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New: Chapter Development Highlights (PDF)

Note: Chapters that do not have news provide their contact information.

Chapters are listed alphabetically, by state/country.

Arizona (Phoenix) Valley of the Sun SoCRA Chapter

The Phoenix SoCRA Chapter is a quarterly forum for anyone interested or working in clinical research. The meeting is held in March, June, September and December of each year in the Phoenix metropolitan area. One continuing education credit (CEC) is available for attending the one-hour, clinical research-related presentation given by an invited speaker (attendance is free!). Past meeting summaries and selected presentations will be available at subsequent meetings.

MEETING ANNOUNCEMENT

Wednesday
December 10, 2008
6:30 – 8:30 PM

Location:
MDS Pharma Services
2420 W Baseline Road
Tempe, AZ 85283

Speaker:
Philip Bach

Speaker Title:
Clinical Site Director

Speaker Affiliation:
MDS Pharma Services

Presentation:
Phil will provide an overview of Phase 1 clinical research, describe the types of studies performed at the site and give a tour of the facility.

Summary:
We will meet the group at the main entrance of the building which is on the back side in the middle (under the big MDS sign). From there we will escort the participants to a gathering location. An overview will be given and then we can take a tour of the facility.

Light refreshments will be provided at the end of the tour. Please bring a friend and spread the word!

CEC Available: 1 Credit

Questions:
Contact Jason Jones, Phoenix SoCRA Chapter Chairperson
602-667-3948
jjones@medicis.com

Planning to Attend? Please RSVP: jjones@medicis.com

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California (Los Angeles) SoCRA Chapter

Date: Wednesday, August 13, 2008

Time: 6:00 pm – 7:30 pm

Topic: Monitoring and Auditing to Ensure Protocol Compliance and GCP

Presenter:
Paula Miner, LVN, CCRP
Lead Clinical Trials Auditor
Office of Clinical Research Quality Assurance
City of Hope

Location:
City of Hope
Platt Conference Room 3
1500 East Duarte Road
Duarte, California

1 CE credit hour is available for SoCRA Certified Professionals

Directions: www.cityofhope.org/About/dir_campus.htm

Campus Map: www.cityofhope.org/About/campusmap.htm

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California (Northern CA) SoCRA Chapter

We are pleased to announce the September meeting of the Northern California Chapter of SoCRA, the Society of Clinical Research Associates.

Topic: Good Clinical Practice (GCP) Jeopardy

Speaker: Daniel Redline, BA, CCRP, CCRC; Pre-Market Clinical Project Manager, Volcano Corporation

Date and Time: Thursday June 4, 2009, from 12:00 – 1:00 PM

Place: UC Davis Medical Center, Clinical & Translational Science Center (CTSC), 2921 Stockton Blvd., Sacramento, CA. For directions to the, please visit: www.ucdmc.ucdavis.edu/ctsc/directions/

Cost: FREE admission (All members and nonmembers welcome)

For more Information: Please contact the following individuals:

Daniel Redline (Chair)
(916) 281-2760
dredline@volcanocorp.com

Denise Owensby (Vice Chair)
(916) 703-9191
denise.owensby@ucdmc.ucdavis.edu

Rayanne Hildreth (Education & Outreach Officer)
(916) 703-9192
rayanne.hildreth@ucdmc.ucdavis.edu

*SoCRA members are credited with 1 hour of Continuing Education (CME or CNE).

Please share this meeting announcement with your colleagues.

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California (Orange County) SoCRA Chapter

Friday, December 12 Cancelled.

Please be informed that SoCRA Orange County Meeting for December 12 has been cancelled. We did not attain enough number of attendees in order to proceed and decided to move the meeting date to early part of next year.

Our goal is to add value to the organization and utilize the opportunity to hear an excellent presenter. That said, we wish to gather as many attendees as we can for this meeting to hear this great topic, "maximizing study enrollment", which is an important part of clinical research practice.

We will keep you updated.

Date: Friday, December 12, 2008

Time: 6:00-7:30 pm

Topic: The Impact of Site Operations & Structure on Patient Recruitment Success

Speaker:
Pete Fronte
President of Altura
Member, IRB at Mission Hospital in Orange County, California
National Speaker/Writer on the subject of Clinical Research Operations

Location:
University of California Irvine, Main Campus
Irvine, CA 92697
Hewitt Hall, Bldg #843
1st Floor, Conference Room #1042

Maps for UC Irvine and the surrounding area can be located at:

www.uci.edu/campusmaps.html or http://today.uci.edu/pdf/UCI_07_map_campus.pdf

FREE Admission (All members and nonmembers are welcome)

More information: Please contact Chapter Chair Maribelle Sunga, BSMT, CCRP at (323) 271-1330, cell (323) 353-2941 or mgsmedresearch@aol.com.

CE: SoCRA members are credited with 1.5 SoCRA Continuing Education Unit.

“Please bring or submit your recruitment issues for group discussion as part of a post-presentation meeting.”

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California (San Diego) SoCRA Chapter

Meeting Announcement

Date: May 27, 2009 Wednesday

Time: 6:00 - 7:00 pm

Place:
The Binding Site
5889 Oberlin Dr #104
San Diego, CA 92121

Speaker: Cathryn Bennett, R.N.

Topic: “Monitoring Trip Reports, the Good, the Bad and the Ugly”

You are invited to this presentation by an experienced clinical trials professional who is a former board member of ACRP. Ms. Bennett will discuss monitor reports from the perspective of the site, the CRA and the Sponsor.

If you are required to write trip reports for your position or not, this is an excellent opportunity to learn from someone in the industry about a key CRA function.

One hour CEU credit is offered for attending this session.

RSVP:
Germaine Schwider
g.schwider@att.net
(949) 433-4211

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California (San Francisco Bay Area) SoCRA Chapter

We are pleased to announce the November meeting of the San Francisco Bay Area Chapter of SoCRA, the Society of Clinical Research Associates.

Topic: “Who has Time to Plan? A How to Guidefor Clinical Research Project Management”

This session will describe how project management tools can be applied to ensure the success of clinical research projects.

Some of the topics that will be covered:

  • Creating a work breakdown structure
  • Learning to influence without authority - leadership at every level
  • The principles of negotiation
  • Developing a process improvement plan

Speaker:

Natalie Currie, BSc. Instructional Designer and Facilitator

Date and Time: Thursday, March 19, 2009, 2:00 – 4:00 PM

Place: UCSF/Mt. Zion campus, Lurie Conference Room, 2340 Sutter Street, 1st floor, San Francisco, CA 94115. Please stop and sign in with front desk guard.

For directions, please visit www.ucsf.edu/maps/mtzion.html

Cost: FREE admission (All members and nonmembers welcome)

For more Information:
Ilana Hettena, CCRP, hettenai@cc.ucsf.edu

* SoCRA members are credited with 1.5 SoCRA Continuing Education Unit (CEU).

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California (South Bay - LA to San Diego Area) SoCRA Chapter

From San Diego to Los Angeles…..covering Southern California, the last piece of the puzzle!

YOU ARE INVITED TO THE FIRST MEETING OF: THE SOUTH BAY CHAPTER OF SOCRA!

When: 10-10-2007 @ 4:00 PM

Where: Breastlink Offices/701 E. 28th St./Suite #414/Long Beach, CA 90806

Contact: Mary Suarez @ 562-933-7866 or msuarez@memorialcare.org

Wondered about SoCRA? Who are they? Where are they? What do they do? Would it benefit me to join?

Do they have fabulous desserts at the Long Beach meetings? (YES!).

Members and non-members are welcome.

The topic of discussion will be Recruitment with guest speakers:

Joetta Wallace MSN, RN, FNPC
Miller’s Children Hospital

Alicia Martin-Santiago/Research Inquiry Coordinator
Chao Family Comprehensive Cancer Center @ University of California, Irvine

Tarek Dessouky, M.D.,DIS, MBA, MPH
Director of American Institute of Research

Looking forward to meeting you all!

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California (Ventura County) SoCRA Chapter

The California SoCRA Chapter of Ventura County would like to invite you to our exciting 2009 Spring Program which will be hosted by Amgen Inc. of Thousand Oaks on Monday, March 23, 2009. The guest speaker, Natalie Currie, will present and generate discussion on "The Globalization of Clinical Research."

Speaker:
Natalie Currie is an instructional designer, facilitator and founder of Natalie Currie, Clinical Research Consulting Inc., a learning and development organization dedicated to pharmaceutical and biotechnology industries, clinical research organizations and academic research centers. Harnessing her 17 years of broad based clinical research experience, Natalie is sought after as a speaker and facilitator in the United States and Canada.

Natalie’s breadth of roles has spanned from Clinical Research Coordinator, Clinical Research Associate, Clinical Research Project Manager and management roles in Government and Health Economics. She has worked at the Addiction Research Foundation (now the Centre for Addiction and Mental Health [CAMH]), Janssen-Ortho Inc. (a division of Johnson and Johnson) and has participated on international project teams for pivotal Phase III studies and led Canadian Phase IIIb-IV studies.

Natalie holds an honors life science degree from the University of Toronto and is a member of the Society of Clinical Research Associates, as well as the Canadian and American Societies of Training and Development.

Natalie designs and facilitates engaging, customized corporate and public workshops in the areas of clinical research study management, train-the-trainer and presentation mastery.

Presentation:
Natalie Currie will examine the opportunities and challenges of conducting clinical trials in a global environment. In addition, she will discuss the ethical, regulatory and practical considerations of conducting trials in emerging countries and will explore what might lie ahead for clinical trials in North America.

Admission:
There is no cost to attend this event. Due to security reasons, you must either be an Amgen employee or be accompanied by an Amgen employee to attend this event.

Date and Time:
12:00 PM to 1:00 PM on Monday, March 23, 2009

Location:
Amgen Inc.
Building 28, Room 28-B-A3
1 Amgen Center Drive
Thousand Oaks, CA 91320

Parking is available in the main parking lot which is located at the intersection of Amgen Center Drive and Pauling Drive.

Agenda:
1. 12:00 PM – 12:05 PM Registration
2. 12:05 PM – 12:10 PM Welcome and Introduction
3. 12:10 PM – 12:50 PM The Globalization of Clinical Research
4. 12:50 PM – 12:55 PM Questions and Answers
5. 12:55PM – 1:00 PM Concluding Remarks
6. 1:00PM – 1:30 PM Networking

One Continuing Education (CE) credit will be given to SoCRA members for attending this meeting.
For more information about this meeting, please contact the Chapter Chairperson:
Ana Sharma, MPH, CCRP
Compliance Manager
Research and Development Compliance
Amgen Inc.
Telephone: 805.313.6264
E-mail: arsharma@amgen.com

Please share this announcement with your colleagues.

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Colorado SoCRA Chapter

Dear Colleagues,

Supplemental Education Meeting: June 18th, 2009

Agenda: Cancer Prevention Research
(1 SoCRA CEU) will be offered

Speaker: Peter Raich, MD

Time: 12:00-1:00 PM

Location: Anschutz Outpatient Pavilion, Room 2005
Note: The building has a new address: 1665 Aurora Ct.

For additional information please contact Sherri Wilke.
sherri.wilke@ucdenver.edu
(720)848-0656

Area map and Fitzsimons campus map

Area Map

Fitzsimons Campus Map

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Connecticut SoCRA Chapter 

Society of Clinical Research Associates (SoCRA) Connecticut Chapter Meeting

Wednesday, October 1, 2008

  • 5:00 - 5:30 pm Registration & Light Supper Provided
  • 5:30 - 6:30 pm Presentation & Discussion

Connecticut Children’s Medical Center
282 Washington Street
Hartford, CT
Conference Room D, Garden Level

Featured Speaker and Topic:
Sarah Kiskaddon, JD
Vice Chair, Institutional Review Board
Connecticut Children’s Medical Center

Improving the Informed Consent Process: A Guide for Investigators in Developing Materials and Presenting Information to Parents and Children

Jointly sponsored by: Connecticut Children’s Medical Center, Hartford Hospital and the Society of Clinical Research Associates

Please RSVP to Bertha Robbins, RNC, CCRP at brobbin@ccmckids.org by September 26th. Members and non-members are welcome.

*1 Continuing Education Credit hour for SoCRA CCRP Renewal will be awarded.

Please share this announcement with your colleagues.

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Crossroads SoCRA Chapter - Indiana/Ohio/Kentucky/Illinois

The Crossroads Chapter of SoCRA presents: The Prevention and Resolution of Compliance Issues – a CRA Perspective

Presented by:
David Finch, CCRP
Senior Clinical Research Associate
Quintiles, Incorporated

Tuesday, January 20, 2009

  • 5:30 PM Check-in
  • 6:00-7:30 PM Meeting

Attendance is free and open to SoCRA and non-SoCRA members.

Indiana University Cancer Pavilion (RT) 101
535 Barnhill Drive
Indianapolis, IN 46202

Parking is available for a fee in both the parking garages south of Michigan Street on Barnhill Drive.

This program has been awarded 1.0 Continuing Education Unit (CEU).

If you plan to attend and would like a CEU certificate, please contact Cynthia Partridge-Bunin at cynthia.partridgebunin@gmail.com.

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Florida (Central) SoCRA Chapter 

M D Anderson Cancer Center Orlando
1400 South Orange Ave, Orlando, FL 32806

“Facets of Clinical Research”

March 26, 2009

9:00 – 9:15 Registration & Welcome

9:15 – 10:00 a.m. “Pediatric Consent/Assent Process”
Robert M. Sutphin, M.D., Pediatric Hem/Oncology
Review the process and reasons for the required processes with dual parent signature and documentation.

10:00 am – 10:45 "Current topics in nursing research: Older women surviving with breast cancer"
Vicki Loerzel, PhD, RN, OCN, Assistant Professor, University of Central Florida College of Nursing
Define nursing research
Discuss research related to older women surviving with breast cancer Describe relationship between UCF College of Nursing and M. D. Anderson Cancer Center Orlando

10:45 a.m. – 11:00 Break

11:00 – 11:45 a.m. “Protecting Human Subjects in Clinical Research Trials”
Gregory Pennock, M.D., Medical Director, Office of Clinical Trials, M.D. Anderson Cancer Center Orlando
The objectives of this talk will be to discuss:

  • Importance of confidentiality in the era of HIPPA
  • Clearly defining patient's rights and responsibilities while on clinical trials
  • Legal cases involving institutions and their research departments

11:45 – 12:30p.m. “Cancer Research: Bench to Beside”
Cheryl H. Baker, PhD, Dir, MDACCO Research Institute, M.D. Anderson Cancer Center Orlando
The objectives of this talk will be to discuss:

  • Provide information to the audience about basic and translational cancer research and how to immediately translate discoveries from bench top research into clinical practice (bedside) in order to find a cure for cancer

12:30 – 1:30 p.m. Lunch (Network with a bag lunch or enjoy various local eateries)

1:30 – 2:15 p.m. “Models of Informed Consent for Participants in Clinical Research Trials”
David Flory, PhD, Chair and Coordinator of Compliance and Special Programs, M.D. Anderson Cancer Center Orlando
The objectives of this talk will be to discuss:

  • The purpose of informed consent
  • The limitations/challenges involved
  • Special cases: vulnerable populations (focus on children as participants in clinical research trials)
  • Recent models designed to address some of the limitations of earlier models (the Informed Consent Conference)

2:15 – 3:00 p.m. “CRC Retention”
Trudy Graves, RN, MS, CCRP
Manager, Office of Clinical Trials
The objectives of this talk will be to discuss:

  • Practices for hiring and retaining Clinical Research Coordinators in an evolving oncology clinical trial environment

3:00 p.m. Program Wrap Up

Please RSVP to Lorraine Hickson, CCRP at Lorraine.hickson@orlandohealth.com or call (321) 841-7021 with any questions.
Valet parking available at M. D. Anderson Orlando.

4.5 SoCRA continuing education credit hours approved*
*SoCRA accepts documentation of candidate participation in continuing education programs for re-certification for programs applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area.

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Florida (South) SoCRA Chapter 

Invitation to Healthcare Professions Interested in Clinical Research

We are pleased to announce the first educational seminar hosted by the South Florida Chapter of The Society of Clinical Research Associates (SoCRA):

Date: Wednesday, March 23, 2005

Time: 12:00 -1:00 p.m.

Location:
University of Miami School of Medicine Diabetes Research Institute
1450 NW 10th Ave
Conference Rm. 6012
Miami, Florida 33136

Topic: Research Methods In Clinical Trials: From The Bench To The Bedside

Guest Lecturer: Aurea M. Flores, Ph.D., University of Miami

Refreshments will be served.

One-hour of Continuing Education Credit is available. Seating is limited.

Please RSVP by March 18, 2005

Contact:
Franciene Coleman, MPH, CCRP, Chapter Chair
University of Miami/ Sylvester Cancer Center
1550 NW 10th Ave.
Fox Bldg
RM 503
Miami, FL 33136

Telephone: 305-243-6823

E-mail: fcoleman@med.miami.edu

***There is no cost involved to attend this lecture.

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Georgia SoCRA Chapter 

Date: May 16, 2009

Time: 10:00 - Noon

Place:
Cross Creek Cafe
1221 Cross Creek Parkway
Atlanta, Georgia 30327

Topic: Increasing Minority Participation in Clinical Trials

(The restaurant will collect a $10 cover charge from all attendees and brunch will be served.)

Presenter: Dr. Nicole Forman
Medical Director, Pediatrics
Sciele Pharma

Speakers Bio:
Dr. Nicole D. Forman received her Doctor of Medicine from the University of Alabama School of Medicine, Birmingham, AL. She completed her Intern and Residency in Pediatrics at Jacobi Medical Center, Albert Einstein College of Medicine, Bronx, NY. She completed her Intern and Residency in Pediatrics at Jacobi Medical Center, Albert Einstein College of Medicine, Bronx, NY. She has served as Medical Science Liaison in Cardiovascular & Metabolism for Novartis Pharmaceuticals and Vice President and Associate Medical Director of Medical Strategy and Clinical Affairs of Lab9 at Cline Davis and Mann. Currently, Dr. Forman serves as the Medical Director of Pediatrics for Sciele Pharmaceuticals in Atlanta Georgia and we are honored to have her as our guest speaker.

Please share meeting date and time with your colleagues.

Sarah Wilson, MS, CCRP
Chairperson Georgia SOCRA Chapter
Phone: 1- 877-847-2186

Lisa Larry-White
Membership & Program Chairperson

Sharon Hyland
Facility Chairperson

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Great Lakes SoCRA Chapter - Michigan/Ohio/Wisconsin

Chapter Chairperson:
Monica Stiddom
Education Coordinator, Michigan Institute for Clinical and Health Research (MICHR)
Program Administrator, Multidisciplinary Clinical Researchers in Training Program (MCRiT)
University of Michigan
24 Frank Lloyd Wright Drive, Lobby M
Ann Arbor, MI 48109-0738
(734) 998-7348
(734) 998-7228 Fax
mhealy@umich.edu
www.med.umich.edu/cacr
www.med.umich.edu/cacr/mcrit
www.clinicalresearchresources.net

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Halifax, Nova Scotia, Canada SoCRA Chapter

The Halifax Chapter of SoCRA presents: A MONITOR’S PERSPECTIVE: “SOURCE DOCUMENTATION”

December 8, 2008 - 1200 to 1315 pm
Room 6015

Halifax Infirmary
1796 Summer Street
Halifax, NS

QEII Health Sciences Centre

1200 NOON – Chapter Update

1215 – 1315 – Presentation Start

Guest Speaker:
Mary-Gordon MacKenzie, BSc; MSc; PhD
Senior Clinical Research Associate
Eli Lilly Canada Inc.
Halifax, Nova Scotia

Please rsvp to:
Sue Moore,CCRP or Lisa Julien,RN, BScN,CCRP
Co-chair, Halifax SoCRA Chapter
Co-Chair, Halifax SoCRA Chapter

Sue.Moore@cdha.nshealth.ca
Lisa.Julien@cdha.nshealth.ca

(902) 473-4128
(902)473-7883

Halifax Infirmary:
Halifax Nova Scotia
1796 Summer Street
ROOM 6015 Classroom - 6th Floor – behind elevators across from 6.2

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Illinois - Chicago Area SoCRA Chapter

Dear Colleague:

The CHICAGO AREA SOCRA CHAPTER Presents a SEMINAR:
Topic: Good Clinical Practice (GCP)

Speaker:
Jean-Luc De Bouver
Clinical Research & DeveloPMent Training Manager
GlaxoSmithkline, Biologicals

Date: Wednesday, May 19, 2004

Time: 1:15 - 4:30 PM

Location:
Four Seasons - Ground Floor
Advocate Christ Medical Center
4440 West 95th Street
Oak Lawn, Illinois

Local Chapter Business meeting will follow the presentation.
4:30 - 5:00 PM

Nominations are being taken for the Local Chapter Chairperson. Please submit your Name (SoCRA members), Title, Institution, SOCRA background and research experience by May 7, 2004 to Rosemarie Schubert at e-mail address below. Volunteers are also needed to serve on the Education Committee. A candidate roster will be generated and forwarded via e-mail by May 14, 2004. Elections for the Local Chapter Chairperson will be held at the May 19, 2004 Business Meeting.

Please RSVP to:
Rosemarie Schubert, R.H.I.T CTR
Advocate Christ Medical Center
By May12, 2004
Rosemarie.Schubert@advocatehealth.com
(708) 346-4603

Or for any other questions:
Diane Braun, RN CCRP
Advocate Christ Medical Center
(708) 346-4209
diane.braun@advocatehealth.com

Cafeteria nearby for refreshments.

1 CE credit hour is available for SoCRA Certified Professionals

Please join us in this seminar on these very important topics and become acquainted with your research colleagues in the Chicago area SoCRA Chapter.

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Kingston, Ontario Canada SoCRA Chapter

When: Thursday September 27, 2007

Where: KGH Shea Conference Rm., Burr 1, Rm: 21-1061

Time: 6:30 PM to 7:30 PM

Guest Speaker:
Chris Gray
Coordinator of Investigational Drug Service - KGH

Please RSVP:
Lesley MacPhail at macphail@kgh.kari.net or (613) 549-6666 ext. 3834

SoCRA CE credit: 1.0

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Maine SoCRA Chapter

The State of Maine SoCRA Chapter will have a meeting on January 24, 2008 at 2PM.

The presentation will be “Adverse Event Reporting using the CTCAE Version 3.0”.

The meeting will be held at Acadia Clinical Research, 304 Hancock St, Bangor, ME, Suite # 2J

Members planning to attend should RSVP:
Ms. Gail Baillargeon, CCRP
E-mail: gail@acadiaclinical.com
Phone (207) 941-9965

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Maryland SoCRA Chapter

This Chapter targets all clinical research professionals. We strive to be in-depth and educational and to offer opportunities for greater understanding of the full clinical research process -- from the nascent steps in the laboratory to the operations of sponsors, CROs, NIH, sites, the business office, and finally onto market approval and post-market studies.

Date: May 20, 2009

Cost: $2.00 admission per person (for meeting room rental)

Presentation: 6:30 p.m. – 7:30 p.m. – offers one hour of CE

Speaker: Anne N. Martien: MBA in Healthcare Administration, CCRP; 20 years of experience in healthcare, business management and clinical trials, Who’s Who of Business Professionals

Topic: Stem Cell Research – Breakthroughs, types of stem cells, consenting for stem cell research, the challenges, and a group discussion of your experiences with stem cell clinical trials will be the focal points of this month’s presentation. Come with your stories to tell!

Optional Networking and Dinner: 6:00 p.m. – 6:30 p.m.
Ordering food or beverages is optional and at the attendee’s expense.
The menu runs from $2.40 to $30, so all budgets can be accommodated.

Location: Burke’s Café Restaurant
36 Light Street (corner of Lombard St. and Light St.)
Baltimore, MD 21202 (2 blocks from the Inner Harbor)
Please ask for the SOCRA meeting when you arrive to be directed appropriately.
Private room on lower floor with our own wait staff.
www.burkescafe.com
Please go to the restaurant’s website for directions and menus.
Please ask for the SOCRA meeting when you arrive to be directed appropriately.
Private room on lower floor with our own wait staff.

Agenda:

6:00-6:30PM Register and Meet Colleagues

Order dinner or/and drinks (optional)

6:30-7:30PM Announcements, Presentation, and Q&A/Discussion

7:30PM Meeting ends

Parking: There is parking on the street (no fee in the evening) around the restaurant and two garages within one block.

SoCRA CEU Credit: 1.0 hour CE is available for SoCRA members.Certificates of attendance will be provided.

RSVP: Anne N. Martien, MBA, CCRP
Chapter Chairperson
E-mail: MDSocra@yahoo.com
Cell: 410-570-9812

Limit: 30 participants (room capacity) so please RSVP
If you have RSVP’d, but will not be able to attend, please call the Chapter Chairperson so that she may call the next name on the waiting list.

Registrar Request: An amiable SOCRA member willing to help attendees sign in, collect the $2 fee, and fill out a nametag would be greatly appreciated. Should you wish to help in this capacity for the March meeting, please call or e-mail Anne Martien.

Please share this announcement with your colleagues.

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Massachusetts SoCRA Chapter

The Boston SoCRA Chapter is a newly formed chapter of the Society of Clinical Research Associates. This chapter will plan to meet 5 times a year.

MEETING ANNOUNCEMENT

DATE:
Wednesday, June 17, 2009

TIME:
4:30-6:00PM

LOCATION:
NOTE: Meeting location changed to HCRI-Harvard Clinical Research Institute, 930 W. Commonwealth Ave., 3rd Floor. Located on the corner of Pleasant St. and Comm. Avenue, the main entrance for HCRI is on Pleasant St. For building access, it is highly recommended to arrive before 5:00PM. Take the Green (B) line to the Pleasant Street stop, cross the street and the building is directly across from the BU Agannis Arena. For those driving, there is parking located at the Dummer Street Garage (off Pleasant Street, behind the building) for a fee and metered street parking on Pleasant Street and Commonwealth Avenue.

SPEAKER:
Dr. Jerri Perkins, MD, Founder and President of Perkins and Perkins, Inc., Medical and Regulatory Consultants

PRESENTATION:
“Demystifying the Process of an FDA Audit: How Should You Prepare for FDA”

SUMMARY:

Bring your questions and join the discussion as we de-mystify the process of FDA audits and help you learn how to be ready when the FDA comes to your site!

CE Credit to SoCRA Members available: 1 Credit

RSVP: Jodi Jensen, RN, CRC. Vice Chair of SoCRA Boston Chapter jjensen@crine.org

INTERESTED IN BEING PART OF THE SoCRA BOSTON CHAPTER?

CONTACT: Lenore Jackson-Pope RN, BSN, ACRN, CCRP, Chair of SoCRA Boston Chapter lpope@crine.org

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Michigan - Saginaw Bay Chapter

The Saginaw Bay Chapter of SoCRA is holding a meeting in conjunction with the IOMSN meeting is Saginaw on April 25th, 1PM to 2PM.

Featured Speaker Topic:
Benjamin M. Segal, M.D.
Holtom-Garrett Professor of Neurology
Director, Multiple Sclerosis Program
Universityof Michigan

Featured Topic:
Research updates in Multiple Sclerosis

Location:
Masude lecture theater St Mary’s Of Michigan Health Education Center
800 S. Washington Ave. Saginaw MI 48601

Contact information and R.S.V.P.
Heather Clark (989) 497-3023

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Minnesota Southeast (SEMN) SoCRA Chapter

The SEMN SoCRA Chapter announces it's inaugural meeting.

When: Monday May 18th. 5:15-6 networking 6-7 speaker

Where:
Mayo Clinic
200 First St. SW
Rochester, Minnesota 55905
Plummer Building 3rd floor room 325B
(parking after 5 is free in any downtown ramp)

Speaker:
Harvey M. Arbit, PharmD, MBA, RAC, CCRP
Director, IND/IDE Assistance Program
Section Head, Regulatory Knowledge and Support
Clinical and Translational Science Institute (CTSI)
University of Minnesota, Academic Health Center

Topic: The FDA is here to do what?!?!
or How to prepare for an FDA inspection

Brief description:

Dr. Arbit has completed training on how to host an FDA investigator and has done so numerous times in his career. He will define the roles of those involved in an FDA inspection and the corresponding responsibilities. The inspection process will be outlined and the information the FDA investigator will be looking for will be discussed. Violations and Warning Letters will be presented as examples of inspection findings.

Beverages and snacks will be provided.

Pease feel free to invite a friend.

Questions or concerns can be directed to:
Teresa Zais 538-0848
zais.teresa@mayo.edu

Most important: 1 CEU will be offered at this meeting.

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Midwest Regional SoCRA Chapter (Missouri)

Colleen Kilbourne-Glynn
Project Manager
Washington University School of Medicine
Pediatrics/ PORU/ CB 8519
4444 Forest Park Blvd.
St. Louis MO 63108
Phone: (314) 286-1180
Fax: (314) 286-1185
Email: kilbourne-glenn_C@kids.wustl.edu

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Mubai, India (Maharashtra) All India

All India Chapter, SoCRA

The first meeting of the SoCRA All India Chapter will be held:

Sunday 21st December 2008
10 AM – 3 PM

Location:
G-12, Ground Floor, Ruia College
Matunga east, Mumbai
400019, India

Speakers:

1. Dr. Dilip Pawar. MD. - Chief Operating Officer, Akela Pharma, Mumbai, India.

Presentation Title: Future of Clinical Trial Monitoring

Summary: Clinical Trial monitoring is of utmost importance in clinical research. Monitoring involves interaction of investigators with sponsors’ team. Improper monitoring might cause build of lot of quires and can prolong the timelines of clinical trial subsequently leading to increasing cost. This presentation will focus on monitoring importance in coming era of e-technology.

2. Dr. Shirish Sherlekar MD. - Head Life Science Practice. Tata Consultancy Services, Mumbai, India.

Presentation Title: Clinical Research Outsourcing trends: Current and Future

Summary: India is one of the top destinations for outsourcing clinical research. India currently offers advantages in the area of English speaking western trained medical and para medical professionals, software skills, treatment naïve patients, economic clinical trials. Will these points support India as a destination for clinical research in next decade?

Contact:

Dr. Vaidehi Limaye.
All India Chapter, SoCRA.
+91 9820506932
+919820345616

Email: socraindia@yahoo.com

This program will offer 2.0 SoCRA Continuing Education Units.

SoCRA Chapter meetings are free to SoCRA members and nonmembers.

Please share this announcement with your colleagues.

All India SoCRA Chapter is a forum for anyone interested or working in clinical research. We conduct regular interactions and meetings through this chapter.

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Nebraska (Central Plains)

In conjunction with the University of Nebraska Medical Center (UNMC)

Presents two opportunities

Wednesdays, June 17 and 24, 2009
12:00 noon – 1:00 p.m.
Room ESH 6020
Eppley Science Hall, University of Nebraska Medical Center
See map for guest parking (yellow and green flags) and directions to ESH 6020 below.

June 17, 2009

Topic: FDA FORMS

Facilitator: AMY FILLER-KATZ, RN, BSN
Clinical Study Nurse Coordinator
UNMC/Radiation Oncology

Educational Objective: Certification preparation to review and discuss the following FDA forms in a group exchange environment:

  • FDA Form 483: Inspectional Observations
  • FDA Form 1571: Investigational New Drug Application (IND)
  • FDA Form 1572: Statement of Investigator
  • FDA Form 3454: Certification
  • FDA Form 3455: Disclosure
  • FDA Form 3500: For Voluntary Reporting of AE and Product Problems
  • FDA Form 3500A: For Use by User-Facilities, Distributors, and Manufacturers for Mandatory

Please visit www.fda.gov/AboutFDA/ReportsManualsForms/Forms/ListFormsNumerically/default.htm for pre-study materials.

June 24, 2009

Topic: THE BELMONT REPORT

Facilitator: MARY PHILLIPS, RN, BSN, OCN

Research Nurse Coordinator

UNMC/Clinical Research Center

Educational Objective: Certification preparation to review and discuss the Belmont Report in a group exchange environment. Please visit http://ohsr.od.nih.gov/guidelines/belmont.html for pre-study materials.

No RSVP necessary. Members and non-members welcome. Please bring a sack lunch if desired. This activity has been planned and implemented in accordance with the Society of Clinical Research Associates. This educational activity received no commercial support. SoCRA has approved each program for 1 continuing education contact hour for members.

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New Mexico SoCRA Chapter

Date: Wednesday, July 8, 2009

Time: 6-7:00 PM

Location:
Gibson Medical Center
(formerly Lovelace Medical Center-Gibson Campus)
West Classroom, Education Building
5400 Gibson Blvd SE
Albuquerque, NM 87108

Agenda: Guest Lecture & Short Chapter Updates

Guest Lecturer:
Human Research Protections Office
University of New Mexico Human Research Review Committee
Albuquerque, NM

Topic: Criteria for IRB Approval and Consent with Decisionally-Impaired Subject Populations

Join the speaker for a brown bag dinner @ 5:30 PM

One hour of SoCRA Continuing Education Credit is available.

Directions:

Approaching from the west of the Lovelace campus or from I-25: Exit on Gibson Blvd East. Travel approximately 2½ miles past San Mateo. Drive to the east side of the Lovelace campus to the light at Valencia. Turn right into the Lovelace parking lot. The Education Building is located at the corner of Gibson and Valencia. Enter the building. The West Classroom is left of the auditorium.

Approaching from the east of the Lovelace campus: From the intersection of San Pedro and Gibson travel west approximately 2 blocks to the light at Valencia. Turn left into the Lovelace parking lot. The Education Building is located at the corner of Gibson and Valencia. Enter the building. The West Classroom is located to the left of the auditorium.

Contact:
Ann Von Worley, RN, BS, CCRP
Clinical Research Associate
Lovelace Clinic Foundation
2309 Renard Pl SE Suite 103
Albuquerque, NM 87106
505-262-7569
505-262-7560 (fax)
ann@LCFresearch.org

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New York State SoCRA Chapter

New York State SoCRA Chapter Education Program Announcement

Saturday, May 9, 2009
Gaylord Meeting Hall
Research Studies Center
Roswell Park Cancer Institute
Buffalo, NY 14203

“FDA Inspection – Uncovering the Mystery”
Kim Downing, Consumer Safety Officer
Food and Drug Administration
New York District/Buffalo Office

“Notes to File - An Auditor’s Perspective”
Lorrie D. Divers, CCRP, Director, Clinical Trials Quality Assurance
ACM Global Central Laboratory

"Perceived Change in Nursing Practice Post Implementation of an Electronic Medical Record in a National Comprehensive Cancer Network."
Louise Zielinski, MS, BSN, RN, CCRP, Clinical Research Coordinator II
Roswell Park Cancer Institute

Catering Fee: $25.00
(This fee will cover cost of food and beverages; Parking not included, parking in Roswell Lot is $6.00)

Suggested Hotel:
DoubleTree Club Buffalo Downtown
125 High Street
Buffalo, NY 14203 (716) 845-0112

Return this form and check payable to caterer “DoubleTree” by April 30, 2009 to:
Virginia Doran, BS, CCRP
Roswell Park Cancer Institute
Clinical Research Services ASB K-106A
Elm & Carlton Streets
Buffalo, New York 14263

~ SoCRA continuing education= 6.0 credit hours ~

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North Carolina (East) SoCRA Chapter

Greetings,

The June, 2009, meeting of the Clinical Research Professionals of North Carolina (a chapter of SoCRA also referred to as NC East or the RTP chapter) will be held on Monday, 1 June 09, at Durham Technical Community College (DTCC), from 6:00 to 7:00 PM.

This month's meeting will feature Celine Clive, President, Polaris Compliance Consultants, Inc., Cary, North Carolina. Celine will be speaking on "A Comparision of Auditing vs. Monitoring". A brief summary of the program and a biosketch for Ms. Clive can be found below.

OUR TOPIC:"A Comparision of Auditing vs. Monitoring"

SPEAKER: Celine Clive, BS, MBA

SUMMARY:
Some study sites are visited by Monitors and Auditors. Why do we need both? Ms. Clive's presentation will compare the monitoring function with auditing activities. Upon completion of this program the participants will:

  • Have an understanding of the responsibilties of monitors and auditors
  • Have an awareness of co-monitoring activities
  • Have an understanding of how the monitoring and auditing functions compare

ABOUT OUR SPEAKER:
Celine M. Clive, President of Polaris Compliance Consultants, Inc., has more than 25 years experience in diverse areas of the drug development process, including positions in pharmaceutical companies and contract research organizations. She has developed and delivered training programs, education manuals and videos on a wide variety of topics. She has assisted numerous clients in the development of customized SOPs and has performed GCP quality assurance audits for Sponsors, CROs, study sites, and Institutional Review Boards. She is a former alternate member of The Copernicus Group IRB and serves on the curriculum committees for several Clinical Research programs.

CREDIT HOURS: This program offers 1.0 SoCRA CEUs

QUESTIONS:
If you have any questions, please contact: jmarnold@cato.com or at any of the numbers below.

  • Phone (919) 768-1201
  • Fax (919) 361-2290
  • Cell 452-0905

DIRECTIONS TO DURHAM TECHNICAL COMMUNITY COLLEGE
Phail Wynn Jr. Student Services Center

  • From I 40 (Take 40W from airport or 40E from Chapel Hill)
  • Take Durham Freeway (Hwy 147) towards Durham (away from RTP)*
  • Take Briggs Ave. exit and make a left (look for DTCC sign)*
  • Cross over overpass and get in far right lane*
  • Take a right onto Lawson St.

From Lawson St., there are 2 locations to park:

Location 1:

  • Turn into the “DTCC Main Campus” parking lot on the right. Across the street, you will see the Wynn Center building (tall, brick building).
  • Go to the cross walk and cross Lawson Street. Follow the sidewalk to the Wynn Center. The Multipurpose Room will be on your left.

Location 2:

  • Pass the “DTCC Main Campus” on right
  • At the first traffic light make left onto Bacon St.
  • Make the first left onto Cooper St. (there will be an elementary school on the right)
  • Just past school, turn right into drive (you will see a sign for DTCC student and faculty parking)
  • Follow the fence beside the “Newton Building” around to the back to the large parking lot.
  • From the parking lot, you can follow the sidewalk between the Newton Building (on your left) and the Glaxo Welcome Technology Center (on your right). You will cross Cooper Street. The Wynn Center is the building right across the street on the left. TheMultipurpose Room is inside on your left.
  • *If coming from Durham towards RTP, take the first Briggs Ave. exit and turn RIGHT. Stay in that right merge lane and turn right onto Lawson St. The remaining directions are the same.

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North Carolina (Winston-Salem/Northwest) SoCRA Chapter

The Northwest North Carolina SoCRA Chapter is pleased to announce its first meeting of 2008.

Date: January 24, 2008

Time: 12 Noon – 1 PM (bring a bag lunch; vending available)

Location: 2nd floor classroom, OTP Building

Topic: Legally Effective Informed Consent: What it Means and How to Obtain It

Speaker: Cheryl Byers, MHA, CIP

About the Speaker: Ms. Byers is the director of the Wake Forest University School of Medicine IRB. Prior to her current position, she worked with WFUSM in research as a project manager and clinical research manager. Her expertise is in the interpretation of the federal regulations as they pertain to the safety, rights and welfare of human subjects who participate in research. Ms. Byers has been with the Institutional Review Board since December 2003. Prior to her work at WFUSM, Ms. Byers worked for managed care, specifically two health maintenance organizations in North Carolina as a health education specialist and provider relations specialist.

Ms. Byers holds a Bachelor of Science degree in Health Education at East Carolina University and a Master of Health Administration from the University of North Carolina at Charlotte. She is also a certified IRB professional and a member of PRIM&R. She has presented nationally for the Association on Clinical Research Professionals (ACRP), the Society of Clinical Trials (SCT) and SoCRA on topics ranging from academic clinical research, clinical research basics, informed consent, and the use of electronic systems for increased compliance. She has also presented in many additional forums on the impact of the HIPAA Privacy Rule on human subject research.

Directions: Wake Forest University Baptist Medical Center is located in Winston-Salem, NC. WFUBMC employees can take the shuttle to the OTP building via the PTCRC shuttle which runs every half-hour from the Main Tower. If you have a group, you can request a pickup by calling 6-RIDE (6-7433) from an internal phone. All others should contact Angela Kimel at akimel@wfubmc.edu or 336-716-6522 for directions as the OTP building is separate from the main campus.

Once inside the building, take the elevator or stairs to the second floor. At the door on the right (left, if taking the stairs), you may scan a WFUBMC badge or ring the bell to gain entrance. Once inside, the classroom is the last door on the left.

Credits: Participants may claim up to one hour of SoCRA CEUs (members may only claim actual time spent in the educational event). Certificates of attendance will be available.

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North Central Regional SoCRA Chapter

North Central Regional SoCRA Chapter presents: Title: "Where the FDA Regulations End and ICH Begins - The Differences and Similarities between the Two in GCP"

This presentation will review the similarities and differences between the FDA regulations and the ICH GCPs and is targeted to investigator sites and the sponsor personnel (CRAs and Study Managers) that work with them.

Learning Objectives:

  • Define what ICH is and what role they play in clinical research
  • Review the ICH Guidelines for Good Clinical Practice (GCP) and how they differ from the FDA regulations
  • Discuss the impact of ICH-GCPs on Investigator sites

Speaker: Paul Below, Clinical Research Consultant

Time and Date: From 4:00 P.M -5:00 P.M on Wednesday April 09, 2008

Location:
University of Minnesota, East Campus
Moos Tower - Room 2-690
515 Delaware Street, S.E.
Minneapolis, MN

SoCRA Continuing Education Credit: 1 hour

All are welcome (SoCRA members and non-members) and this presentation is free of charge to all.

Please RSVP to:
Jessy Thomas
Email: thoma098@umn.edu
Phone: 612-624-2431

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Ohio "Northeast" SoCRA Chapter

Date: Tuesday, February 12, 2008

Time: 6-8 PM (Light dinner will be provided)

Location:
Summa Health System
525 East Market Street
Akron, Ohio 44304
Critical Care Center Building, Ground Floor Lobby Reception Area

Guest Speaker: Jennifer Oettinger, R.N., J.D.

Jennifer Oettinger is the Manager of Contracts & Budgets in the Research Administration Business Office at the MetroHealth System in Cleveland. Jennifer has over fifteen years in the medical field, including bedside nursing, and administration. She graduated with her law degree in 2002. In 2004 she joined The MetroHealth System of Cleveland in the Research Administration Business Office as the lawyer overseeing budgets and contracts.

Topic: Maximizing Compliance: Developing and Operationalizing the Research Billing Process in Today’s Climate

Objectives:

1. Review of specific federal/legal regulations that impact on clinical research billing practices.

2. How to be compliant with the regulations. (pre-award)

3. How to monitor compliance with regulations. (post-award)

SoCRA CEUs: 1.0

All are welcome (SoCRA & non-SoCRA Members) to attend our Northeast Ohio Local Chapter Meeting. This will be a great opportunity to network with other research professionals. Dinner will be provided.

PLEASE RSVP TO
Dawne Bowman at 330-460-5030
or by e-mail dbowman@m3clinical.com

R.S.V.P. EARLY AS SEATING IS LIMITED!

If you have any questions, please contact Kristi DeFranco or Dawne Bowman at 330-460-5030

DRIVING DIRECTIONS:

From the North: Take I-271 South to Route 8 South. Follow Route 8 South until you reach the Akron area. Take the Perkins Street/Route 59 exit and turn left at the top of the exit ramp. Go through the traffic light at Fountain Street. Turn right on Arch Street. Turn left onto Forge Street. Turn right onto Adams Street.

From the Northwest: Go east on the Ohio Turnpike (I-80). Take the Route 8 exit ramp. Travel on Route 8 South until you reach the Akron area. Take the Perkins Street/Route 59 exit and turn left at the top of the exit ramp. Go through the traffic light at Fountain Street. Turn right onto Arch Street. Turn left onto Forge Street. Turn right onto Adams Street.

From the East: Take I-76 West to Route 8 North. Stay in the right-hand lane. Exit at Buchtel Avenue.

Go through Carroll Street and Buchtel Avenue intersections. Turn right onto East Market Street. Pass Arch Street. Turn left onto Adams Street.

From the West: Take I-77 South. Approaching Akron, it will turn into I-77/I-76. Turn left onto Route 8 North. Take Buchtel Avenue exit. Go through Carroll Street and Buchtel Avenue intersections. Turn right onto East Market Street. Pass Arch Street. Turn left onto Adams Street.

From the South: Take I-77 North to Route 8 North. Exit at Buchtel Avenue. Go through Carroll Street and Buchtel Avenue intersections. Turn right onto East Market Street. Pass Arch Street. Turn left onto Adams Street.

Valet parking is easily accessible. The cost is $4.00.

  • At the Critical Care Center on the south side of Arch Street.
  • At the 95 Arch Street building on the parking lot side.
  • At the Emergency Department entrance.
  • At the hospital’s Main Entrance.

Parking

Parking is available in the Professional Center North Parking garage located at 75 Arch Street. Enter the Critical Care Center Building and the meeting will be held in the lower lobby area. Parking will cost approximately $5.50.

Thank you and we look forward to seeing you!

Kristi DeFranco, M3 Clinical Research, Inc.

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Ohio Valley SoCRA Chapter

Dear Colleague:

We are pleased to announce the first meeting of the Ohio Valley Chapter of SoCRA, The Society of Clinical Research Associates.

Topic: What to expect in an FDA audit

Sub-Topics:

  • Informed Consent in Pediatrics
  • Good Clinical Practice
  • IRB investigations
  • Investigator Data Audits

Date: Oct 6, 2004 (Wednesday)

Time: 6-7:30 PM

Place: Cincinnati Children's Hospital Medical Center Sabin Auditorium

Speaker: Hugh McClure, FDA Investigator/Bioresearch Monitoring Specialist

Cost: FREE admission Refreshments provided

Please RSVP to Tiffany Losekamp, Chapter Chairperson at 513-759-5128 or Tiffany.Losekamp@cchmc.org

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Oklahoma SoCRA Chapter

Dear Colleague,

You are invited to our next Oklahoma SoCRA Chapter meeting:

When: Wednesday, June 14th - 11:30 AM -1:00 PM

Where: OUHSC Bird Library – Provost Conference Room #223

Topic: “An Access Data Base Experience”

Presented by: Elaine Reeves, CCRP, Clinical Research Coordinator, Pediatric Hematology Oncology

RSVP to : Christina-Gonzalez@ouhsc.edu

Come see what can be shared about utilizing an Access Data Base for managing patients and IRB info. Elaine has been using her system in various forms for 20+ years and is willing to share some tips with us. Please come and join us and bring those who might be interested.

We will be having a “Chef Salad” pot luck lunch (see list below). If you do not wish to participate in the potluck then feel free to bring your own lunch.

What we have:

  • Large bag lettuce x4
  • Cheese x2
  • 1lb chopped turkey x1
  • 1lb chopped ham x1
  • Tomatoes x1
  • Carrots
  • 6 eggs boiled & sliced/chopped
  • Can black olives chopped
  • Crackers x2
  • 1 sliced red onion
  • Dessert x2
  • Fruit
  • Sprite & Coke
  • Diet Coke x2
  • Lg. bottle Ranch dressing

What we need:

  • 1lb chopped turkey x2
  • shredded cheese x1
  • 2 tomatoes chopped x2
  • 1lb chopped ham x2
  • Broccoli
  • Cauliflower
  • Celery
  • Croutons x2
  • Bacon Bits
  • Dill pickles
  • Plates
  • Forks
  • Diet DP
  • Lg. bottle bleu cheese dressing
  • Napkins
  • Lg. bottle of Italian dressing
  • Cups

Please RSVP’s to Christina Gonzalez at (405) 271-4412 ext. 42551 or email Christina-gonzalez@ouhsc.edu to let us know what you will be bringing or if you are bringing your own lunch. Space limited to 40. Directions are available for those of you not on campus.

1 hr. Continuing Education Credit available

SOCRA is the Society of Clinical Research Associates. Our local chapter is committed to providing education on campus and statewide to those involved in clinical research. Our meetings are held on the 2nd Wednesday of every month. Please feel free to come even if you are not a member of SOCRA. You can find further information about the national SOCRA organization and certification testing at www.socra.org

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Oregon SoCRA Chapter

Chapter Chairperson: Angela Rock

Phone: 503 490 8381
FAX: 971 275 1867
Email: angela.rock@welchallyn.com

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Ottawa, Ontario Canada SoCRA Chapter

Wednesday April 8, 2009@ 17:00 – 18:00

Elizabeth Coletta RN CCRP
The Ottawa Hospital – General Site

Presenting: “Berliner Bed Rest Study: A Model in Collaboration”

Location: The Ottawa Hospital – General Campus – Room SD-D

Room directions: In the main building take the “service” elevator to the SD level, then turn right. Go to the end of the hall, turn left. It is the 1st room on the left.

Parking: On site parking available – hourly rate

1 SoCRA CEU credit hour

Contact Information: Gwen Ewart RN CCRP

T# 613-798-5555#19233

Email: gewart@ottawaheart.ca

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Pennsylvania / Delaware Valley SoCRA Chapter

PA/Delaware Valley SoCRA Chapter
Cordially Invites You to Attend the Educational Program, "Core Best Research Management Practices"

Feature Presenter:
Gregg Fromell, M.D.
Executive Director, Office of Human Research
University of Pennsylvania

Thursday, November 6, 2008
4:30 PM – 6:00 PM

Thomas Jefferson University
Hamilton Building - Room 505
221 S. 11th Street
(Located on Locust Street between 10th and 11th)
Philadelphia, PA 19107

There is no charge for this program.
Beverages provided.

Parking is the responsibility of the attendee.
The Thomas Jefferson University Hamilton Parking Garage is located on 11th and Locust Street. Thomas Jefferson is also acceptable through public transportation

Available space restricts attendance to the first 70 people to RSVP.

*Qualifies for 1.5 CE credit hour for SoCRA CCRP Renewal

"The Society of Clinical Research Associates (SoCRA - www.SoCRA.org) accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area."

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Tennessee, Greater Nashville Regional SoCRA Chapter

States: Middle Tennessee/Greater Nashville, Western Kentucky

Wednesday, June 25, 2009

12-1pm

Room 898 PRB*

Featured Topic:
Reproductive Health Research with Incarcerated Populations

Speaker: Kristy Kummerow, VMS III

Unintended pregnancies affect women of all races, ethnic groups and socioeconomic classes in the United States, but certain groups have higher rates than others. This talk will review the relationship between pregnancy and incarcerated women that was revealed during a study with female inmates at a Nashville jail. Discussion will also focus on research with vulnerable populations.

Sponsorship: Jointly sponsored by Vanderbilt School of Medicine; Department of Medicine, Division of Rheumatology and the Society of Clinical Research Associates.

Accreditation and Credit Designation: Vanderbilt School of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. Vanderbilt School of Medicine designates this educational activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)TM. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Disclosure Statement: It is the policy of Vanderbilt School of Medicine that participants in CME activities be made aware of any affiliation or financial interest that may affect the planner’s involvement and speaker’s presentation(s). Each planner and speaker has completed and signed a conflict of interest statement; these relationships will be disclosed to the audience.

Commercial Support: This educational activity received no commercial support.

Course Director, Annette Oeser has no financial relationships to disclose. Speaker, Wendy Lloyd has no financial relationships to disclose.

Please RSVP to wendy.lloyd@vanderbilt.edu by June 22. Members and non-members welcome. Please bring your lunch.

SoCRA has approved this program for 1 continuing education contact hour for members.

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Tennessee, Mid-South SoCRA Chapter

When: June 10, 2009, 1:30 – 2:30 PM

“Key Elements of Research Compliance”

3.0 CEU SoCRA hours

Location: St. Jude Children’s Research Hospital (SJCRH), Auditorium (Patient Care Center)

  • 8:00 – 8:30 am: Registration and Sign- In (Continental Breakfast)
  • 8:30 am: Welcome
    Nancy West, RN, BSN, CCRP, Chair MidSouth Chapter of SoCRA
  • 8:35 - 9:30 am: HIPAA and Clinical Research
    Morris Landau, JD, Privacy and Security Compliance Officer, Office of Ethics & Compliance, St Jude
  • 9:30 – 10:30 am: Research Misbehavior
    Sharon Post, JD, Chief Compliance Officer, Director, Office of Ethics & Compliance, St. Jude
  • 10:30 – 10:40 am: Break
  • 10:40 – 11:30 am: You’ve Been Warned…Warning Letters From the FDA
    Laura B. Cummins, JD, Manager, Contract Administration Office of Clinical Research, UT Medical Group, Inc.

Everyone welcomed and there is no fee to attend!

Contact Information:

Nancy West: nancy.west@stjude.org or 901.595.6018

Yvette Montague: yavette.montague@stjude.org or 901.595.6018

Driving Direction to SJCRH, Memphis, TN:

Traveling West:

  1. I-40 E into Memphis.
  2. Exit 1B on Danny Thomas Blvd.
  3. Turn right on Alabama Ave.
  4. Turn right on N. Lauderdale.

Traveling East :

  1. I-40 W into Memphis.
  2. Exit 1C on Danny Thomas Blvd.
  3. Turn right on Alabama Ave.
  4. Turn right on N. Lauderdale.

Traveling North:

  1. I-55 N into Memphis.
  2. Exit right onto I-240 W.
  3. Exit I-40 W.
  4. Turn right on Exit IC on Danny Thomas Blvd.
  5. Turn right on Alabama Ave.
  6. Turn right on N. Lauderdale.

Traveling South:

  1. I-55 S to I-40 E.
  2. Exit 1B on Danny Thomas Blvd.
  3. Turn right on Alabama Ave.
  4. Turn right on N. Lauderdale.

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Texas, Greater Houston/Galveston SoCRA Chapter

This announcement is a "heads up" notice that an educational workshop will be held on April 5, 2008 in the Texas Medical Center from 9 AM to 5 PM.

Attendees will be eligible to receive up to 6 CEUs.

Notifications with further details will be e-mailed as they become available.

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Texas, West SoCRA Chapter

February 12, 2009

5:30-7:30 PM CST

TOPIC: Designing Clinical Materials for Low-Literacy Populations

SPEAKER:
Courtney J. Schoessow, MPH
Senior Partnership Program Coordinator, South Central Region
National Cancer Institute
Cancer Information Service

SUMMARY: Ms. Schoessow will discuss how to design clinical trial materials for low-literacy populations.

Upon completion of this presentation the participants will:

  • Describe the 3 key functions of the National Cancer Institute, Cancer Information Service.
  • Discuss issues surrounding health literacy in the United States, specifically related to informed consent materials.
  • Analyze readability-level of informed consent and health education materials.
  • Employ word recognition tests for potential participants.
  • Design health-education materials utilizing 20 practical guidelines.

LOCATIONS:

  • Lubbock – ACB 220 (Academic Classroom Building – located at front of HSC on 4th and Indiana)
  • El Paso – 235
  • Amarillo – 4717
  • Odessa – 1C12

For further information: Terry Fountain, CCRP
806-775-8590

Please RSVP by February 9, 2009: terry.fountain@umchealthsystem.com

Food will be provided for the Lubbock campus only.

*2 Continuing Education Credit hours for SoCRA CCRP Renewal will be awarded.

Meetings are open to members and non-members.

Please share this announcement with your colleagues.

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Tokyo, Japan SoCRA Chapter

JAPAN CHAPTER SEMINAR ANNOUNCEMENT

Date: June 27 2009

Time: 13:00 - 15:00

Location:
Institute of Biomedical Research and Innovation
4th Floor Training Room , 2-2
Minatojima-Minamimachi Chuo-ku - Kobe Japan

Directions / map: www.ibri-kobe.org/english/foundation.html#3

Registration: 12:30 -13:00

Program: 13:00 – 15:00

Language: Japanese only

Speaker title: Recent amendment of ethical guidelines on clinical research and legal responsibility of institutional review board

Name of speaker: Yuichiro Sato, LL.M, Associate Professor, Kobe Gakuin University, Faculty of Law

CCRP credit: 3.0 CE

Participation fee: free

Japanese information: www.crsu.org/SoCRA_Japan/

Advanced registration: Please email to SoCRAJapan_Committee@umin.ac.jp including your name, affiliation, by March 19, 2009.

Please see the announcement in Japanese.

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Toronto, Canada SoCRA Chapter (Greater Toronto)

” Clinical Research and the Web 2.0”

Speaker: Sarah Beales MSc.; CCRP

Date: Thursday, June 25 2009

Time: 5:30pm-7:00 PM

Location:
Princess Margaret Hospital
PMH Auditorium 6-604
610 University Avenue, TO, ON

Please bring your refreshments

RSVP: susanna.sellmann@uhnresearch.on.ca

Tel: 416 581-8624 leave voicemail. Voicemail messages will not be returned.

SoCRA CE credit: 1 hour

GTA SoCRA Chapter contact: Susanna Sellmann

Please share this announcement with your colleagues.

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Vancouver, Canada SoCRA Chapter

The Vancouver SoCRA Chapter in conjunction with Fraser Health Authority are pleased to announce:a Clinical Trials Research Management Symposium

Presentations & Speakers:

  • Essential Documents for Clinical Trial Research
    Erin Cherban (Centre for Health Evaluation and Outcome Sciences)
  • Assessing the Health of Privacy in Clinical Research: Fit or Failing?
    Catherine Tully (BC Office of the Information and Privacy Commissioner)
  • Clinical Research Agreements and You
    Roger Kuypers (Fasken Martineau)
  • Perspectives from a Research Co-ordinator Running a Clinical Trial Site
    Lynn Breakwell (SMH Cardiology Clinical Trials)

Presentations are followed by a networking lunch

Participants will receive 3.0 CE hours towards SoCRA re-certification.

Date: Friday, June 12, 2009

Time: 8:00 - 12:25

Location:
Royal Columbian Hospital
Sherbrooke Building - Lounge
330 East Columbia Street
New Westminster, BC V3L 3W7

To register: Please contact Camille Viray: camille.viray@fraserhealth.ca with the following details:
Name:
Title/Department:
Place of Work:
Phone Number:
Email:

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Vermont SoCRA Chapter

Date: Wednesday, June 17, 2009

Time: 12:00-1:00 EST

Title of Program:
The Five Rights for GCP Regulatory Affairs: Regulations, Approvals, Reporting, Record Keeping and Readiness

Speaker Name: Deidra Poucher, RN, BSN, MSHS, CCRC

Location:
The University of Vermont/Fletcher Allen Health Care
General Clinical Research Center (Baird 7)
Burlington, Vermont 05401

1.0 SoCRA continuing education credit hours approved*

*SoCRA accepts documentation of candidate participation in continuing education programs for re-certification for programs applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area.

Directions:

From I-89 North or South

  1. Exit 14 W
  2. Bear RT onto East Avenue
  3. The University of Vermont/Fletcher Allen Health Care on LT
  4. Parking garage on RT, valet parking available at main entrance
  5. From Main Entrance follow signs to Baird Building
  6. Take Baird Elevators to 7th FL

Program Objectives :

Participants will lean the governing regulations (Code of Federal Regulation Title 21) and overseeing guidance documents and information sheets guiding the conduct and reporting of clinical studies. Upon completion of this session attendees should be able to:

  • Discuss regulations and ICH Guidelines governing the conduct of clinical trials
  • Define the different reporting requirements for drug, device and biologic studies associated with GCP Regulatory Affairs
  • Define key regulatory documents and site’s readiness for start ups and inspections
  • Develop a streamlined approach to regulatory record keeping

For more information contact the Vermont Chapter Chair:
Angela J. Ricci, MSHS, CCRP
Tel: 802-288-9007
Email: angela.ricci@av.abbott.com

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Washington SoCRA Chapter

Washington State Chapter meeting

Date: Thursday, October 23, 2008

Time: 5:00 pm - 9:00 pm

Program: University of Washington Tumor Vaccine Group Open House

Refreshments and hors d'oeuvres will be provided/sponsored by selected area restaurants

5:00 pm - 5:30 pm
Register SoCRA Attendance, Meet SoCRA Colleagues

Visit Tumor Vaccine Group Displays and Posters

5:30 pm Lab Tours

6:30 pm Presentations:

  • Cancer Vaccine Development
  • Modulating the Immune System
  • Cancer Diagnosis
  • Translating Discoveries to Clinical Trials

7:30 pm Panel Discussion

8:00 pm Lab Tours

9:00 pm Wrap Up

Speakers Include:

  • Dr. Mary L. "Nora" Disis
    Director & Founder, Tumor Vaccine Group
    Professor, Dept of Med. Div Oncology
    Member, Fred Hutchinson Cancer Research Group
    Director, UW Center for Translational Research in Women's Health
  • Dr. Lupe G. Salazar
    Principal Investigator, Tumor Vaccine Group
    Assistant Professor, Dept of Med, Div Oncology
    Staff Physician, Seattle Cancer Care Alliance & UW Medical Center
  • Dr. Hailing Lu
    Principal Investigator, Tumor Vaccine Group
    Research Assistant Professor, Tumor Vaccine Group

CEU: SoCRA members may claim up to 2.5 hours of CEUs for SoCRA recertification.
(members may only claim actual time spent in the educational event).

Location:
Tumor Vaccine Group
University of Washington South Lake Union Campus
815 Mercer Street
Seattle, WA 98109

Free Parking On-Site
No Charge for Attendance
Hors d'oeuvres provided

SoCRA members and non-members welcome, please invite your colleagues! This event is open to the public.

RSVP: Merle Witter, CCRP
mtwitter@comcast.net

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Washington D.C. "National Capital Area" SoCRA Chapter
(D.C., Maryland, Virginia)

Wednesday, June 10, 2009

Time:
5:30 pm Meet and Greet
6:00 pm Start of presentation

Presentation: “How a Sponsor Can Work within Regulations and Still Plan an Active Role in helping Investigator Recruitment through Patient and Site incentives”

Presenter:
Rose Mary Padberg, RN, MA
National Cancer Institute

Objectives:

  • Ethical and regulatory standards essential for recruitment
  • Development of a Protocol that is feasible without being too restrictive
  • Educational requirements for P.I.’s and staff to ensure retention of subjects
    Presenter: Maria F. Malone, CCRP

Location:
Kaiser Permanente Regional Headquarters
2101 E. Jefferson St.
Rockville, MD 20852

Credits available:
1.0 CE credit hour for SoCRA CCRP Renewal "The Society of Clinical Research Associates (SoCRA) accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area."

Room: Desert Center Floor 3E

RSVP: Maria Malone - malonemf@medimmune.com

Parking:

Underground parking is available, there is very limited outside parking. Parking is free if you park in the building garage. The garage closes at 6pm.

However, you are able to get out of the garage at all times (pull up to the entrance and the door will open). NOTE: The attendant leaves at 6pm and the garage will close. Therefore, guests need to ensure they have arrived onsite before 6pm if they want to park in the garage otherwise you will need to park outside.

Driving Directions:

Note: With ongoing construction of the new Montrose Parkway, the entrance to Kaiser Permanente has moved and is no longer on E. Jefferson. The new entrance to Kaiser Permanente is from Montrose Parkway. The front of the building faces Montrose Parkway , and there is a stoplight at the new entrance.

Directions:

  • From I-270 south: Take exit 4A, Montrose Road east. There is a detour onto the new Montrose Parkway. Turn right at the first light on Montrose Parkway , which is at the Kaiser Permanente Regional Office. Follow the driveway to the left and park in the underground garage.
  • From the I-495 innerloop: Take the I-270 split north to exit 4A, Montrose Avenue east. There is a detour onto the new Montrose Parkway. Turn right at the first light on Montrose Parkway , which is at the Kaiser Permanente Regional Office. Follow the driveway to the left and park in the underground garage.
  • From the I-495 outerloop: Take the I-270 split and exit on Old Georgetown Road north. At the fourth light, turn left onto Executive Boulevard. Executive Boulevard becomes East Jefferson. Turn left on the new Montrose Parkway. Turn left at the first light, which is at the Kaiser Permanente Regional Office. Follow the driveway to the left and park in the underground garage.

2009 Upcoming Meeting Schedule

Date, Conference Room, Floor, Time

  • June 10, Desert Center, 3E, 5:30 PM
  • July 8, Desert Center, 3E, 5:30 PM
  • August 12, Desert Center, 3E, 5:30 PM
  • September 9, Desert Center, 3E, 5:30 PM
  • October 14, Desert Center, 3E, 5:30 PM
  • November 11, Desert Center, 3E, 5:30 PM
  • December 9, Desert Center, 3E, 5:30 PM

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Wisconsin SoCRA Chapter

Research: What’s on the Horizon?

Date: Saturday, September 13, 2008

Place:
Mid-State Technical College
Marshfield, Wisconsin

Sponsored by:
Marshfield Clinic Research Foundation-Clinical Research Center
Mid-State Technical College

PROGRAM

  • The Marshfield Clinic Personalized Medicine Research Project
    Cathy McCarty, PhD
  • Biomedical Informatics – The Horizon is Just the Beginning
    Trish Siegler, MBA, PMP
  • Evidence Based Practice-Reducing Central Line Infection using Innovations: Implementation of the BioPatch and CDC guidelines
    Dena Jarog, DNP, RN, CCNS
  • Improving Warfarin Dosing Through Genetic Testing
    James K. Burmester, PhD, MS
  • Considerations When Doing “Investigator Initiated” Research
    Karen Olson, RN, BSN

LEARNING OBJECTIVE:

For participants to be introduced to future trends in genetic, evidence based, investigator initiated and bio-informatics research.

Location:

The conference will be held at:
Mid-State Technical College
Marshfield Campus
2600 W 5th Street
Marshfield, Wisconsin
www.mstc.edu/marshfield.html

Please park in the back parking lot. Signs will be posted.

FURTHER INFORMATION:

If interested in attending, contact:

Mary Spindler LPN, CCRP
spindler.mary@marshfieldclinic.edu
Phone: 715-387-9444

Wendy Foth BS, CCRP
foth.wendy@marshfieldclinic.edu
715-389-4470

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