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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

Monday, June 16, 2008
6:00 – 7:30 PM

Location:
Good Samaritan Hospital, 3rd Floor
Prenatal Classroom 12th Street and McDowell
Phoenix, AZ 85006

Map: Click here.

Directions:

From McDowell Road

  1. Turn south on 12th Street.
  2. Once on 12th Street, take your 1st right, and then take your first left.
  3. This will bring you to the parking garage.
  4. Park on the 3rd floor and take the sky bridge across to the hospital.
  5. Enter the glass door and turn right at the first hallway.
  6. Look for the Prenatal Classroom.

Speaker:
Mitchell Horowitz, MPP

Speaker Title:
Managing Director, Battelle Technology Partnership Practice

Speaker Affiliation:
Battelle under contract with the Arizona Biomedical Research Commission

Presentation:
The Arizona Translational Research Pathway Initiative – Origins, Progress and Ongoing Activities

Summary:
Mr. Horowitz will discuss the ongoing Arizona Translational Resource Network, an initiative of the Arizona Biomedical Research Commission, developed with support of the Flinn Foundation as part of Arizona’s Bioscience Roadmap efforts.

The Arizona Translational Resource Network (AZTransNet) is an ongoing initiative supported by the Arizona Biomedical Research Commission to provide Arizona with the capacity to facilitate and coordinate translational and clinical researchactivities in Arizona, particularly approaches for:

  • Harmonizing clinical research policy approaches.
  • Developing shared infrastructure in common needs areas such as training, access to IRB support and outreach to physicians for clinical research.
  • Establishment of a new culture of trust and cooperation by serving as an honest broker.

AZTransNet is an outgrowth of the Arizona Translational Research Pathway sponsored by the Arizona Biomedical Research Commission and the Flinn Foundation, and guided by the input of leaders from Arizona’s universities, nonprofit research institutions, hospitals and medical centers and broader stakeholders.

The starting point for AzTransNet is to advance a set of pilot projects identified as part of the development of the Arizona Translational Research Pathway approach undertaken in 2005 and culminating with the June 2006 report, Seizing the Translational Research Opportunity in Arizona. These pilot projects include:

  • Creation of an Institutional Review Board (IRB) Networking Forum to raise awareness of issues, foster collaborations and create a sense of community and trust among IRBs in the state.
  • Initiation of Technical Policy Development Retreats to address complex issues facing IRBs with in-depth education and policy guidance, with the initial retreat addressing IRB policies for serum and tissue repositories. An upcoming Patient Registry Retreat is being held on June 4, 2008 in Scottsdale. The retreats also offer continuing education credits. For more information go to: http://events.signup4.com/patientregistry
  • Formation of an Arizona Clinical Research Consortiumto facilitate collaborations of community physicians and clinical research leaders to increase clinical trials activities in the state.
  • Development of a Community-Based Participation Guide for advancing collaborations with Native American and Hispanic/Latino Populations Groups
  • Assessment, design and formation of an Arizona Community Institutional Review Board (IRB) to provide IRB support for independent research sites that lack in-house IRBs and clinical studies that span multiple research sites.

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

Do You Plan on Having Dinner?
Dinner will be provided for $5 each. Please indicate if you plan on having dinner.

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

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California (Los Angeles) SoCRA Chapter

Date: April 9, 2008

Time: 6:30 PM

Topic: Keeping Study Participants Informed — New Ideas about “New Information”

Presenter:
Holly Weisbuch, BS, CCRP
Quality Assurance Supervisor
Clinical Investigations Support Office
USC/Norris Comprehensive Cancer Center

Goal:
To better understand 45 CFR 46.103 (b) (4) - “New Information”
The consent process and its documentation should be revised when deficiencies in its accuracy or completeness are noted, when new information about reasonably foreseeable risks and potential benefits becomes available, or when other additional information becomes known that will improve the consent process. Such revisions must be reviewed and approved by an IRB prior to the revised consent being utilized except when necessary to eliminate apparent immediate hazards to subjects (45 CFR 46.103(b)(4)).

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 February meeting of the Northern California Chapter of SoCRA, the Society of Clinical Research Associates.

Topic: “Data and Safety Monitoring Boards (DSMBs): When are they needed?”

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

Date and Time: Wednesday, June 18, 2008, from 4:00 – 5:00 PM

Place: UC Davis Medical Center, Clinical and Translational Science Center (CTSC), 2921 Stockton Boulevard, Suite 1400 (near Broadway Blvd.), Auditorium, Sacramento, CA 95817. For directions to the CTSC, 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)
(707) 224-3200 ext 3537
daniel.redline@dey.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 SoCRA Continuing Education Unit (CEU).

Please share this meeting announcement with your colleagues.

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California (Orange County) SoCRA Chapter

We are pleased to announce the FIRST SoCRA chapter meeting in Orange County, Southern California.

Date: Friday, May 23, 2008

Time: 6:00-7:00 pm

Topic: Maximizing Study Enrollment

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, 1st floor conference room

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 SoCRA Continuing Education Unit.

“Bottled water, fruit and cookie bars will be served”

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California (San Diego) SoCRA Chapter

Meeting Announcement

Date: May 28, 2008 Wednesday

Time: 6:00- 7:00 pm

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

Speaker: Kathy Valasek, J.D., Director, Quality Assurance and Regulatory Compliance, Somaxon Pharmaceuticals

Ms. Valasek provides QA expertise and oversight of audit plans and contract auditors for clinical and preclinical activities for Somaxon. She provides regulatory and compliance guidance for her company.

Topic: “QA or Supermonitoring- Is the Auditor a SuperMonitor?”

Objective:
To gain understanding on the differences and issues surrounding the QA process and the auditing process in a clinical trial

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: “Monitoring Investigator-Initiated Trials: The Roles of the Institution and the IRB” and “Targeted Monitoring: the Role of the Project Manager in Government Network Sponsored Trials”

Speakers:

  • Daniel Redline, CCRP, CCRC, Assoc. Manager of Clinical Affairs, Dey, LP
  • Tony Perez, JD, Director, UC Davis IRB Administration
  • Nariman Nasser, BS, CCRP, Mgr. of Clinical Operations, Immune Tolerance Network, UCSF

Date and Time: Thursday, November 15, 2007, 5:00 - 6:30 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:
Contact Chapter Chair, Beverly Fein, MSN, CCRP
bfein@cc.ucsf.edu
or Ilana Hettena, hettenai@surgery.ucsf.edu

* SoCRA members are credited with 1 SoCRA Continuing Education Unit (CEU).

** This will be a repeat of the presentation at the SoCRA Annual Conference in Denver.

***This topic will also be presented at the Northern California Chapter meeting, November 14, 2007.

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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 2007 Fall Program which will be hosted by Amgen Inc. of Thousand Oaks on Tuesday, November 6, 2007. The guest speaker, Diane Kulisek, will present and generate discussion on "The Quality Metrics: Dashboards and Scorecards".

Speaker:
Diane Kulisek has over 30 years of practical experience within the quality profession and is President of CAPAtrak, LLC, a contract provider of quality assurance and regulatory compliance leadership, services and solutions. She has held key management positions within the consumer products, aerospace and biomedical industries, most recently as Vice President of Quality and Regulatory Affairs for Spectrum Laboratories. Her career has included eight years within the Gillette Company, climbing to a final position as manager of Quality Engineering and the Product DeveloPMent Laboratory at Gillette’s Santa Monica Manufacturing Center and nine years within Rockwell International, culminating with her role as Associate Product Manager for Avionics & Controls on NASA’s Space Shuttle Main Engine Program. Diane is currently Chair-Elect for the Food, Drug and Cosmetic Division of the American Society for Quality (ASQ) and Quality Advocacy Chair for the San Fernando Valley Section of ASQ. She is recognized by ASQ as a Certified Manager of Quality/Organizational Excellence and as a Certified Quality Engineer.

Presentation:
Quality metrics visually represent relevant data and provide a means by which to convert information into results. Diane Kulisek will provide an overview of Quality Dashboards and Balanced Scorecards as they relate to Strategic Quality Planning, share links to popular on-line references relating to these topics and summarize Quality Management System guidelines and regulatory requirements pertaining to Quality Planning and Metrics. She will review examples of Scorecards and Dashboards while providing insight, based upon her own experience, about how organizations can apply these tools to achieve higher levels of customer satisfaction, waste reduction and continual improvement. On-line access to a free, editable, Quality Planning Procedure, as well as Scorecard and Dashboard templates, will also be included with this presentation.

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:
6:00 PM to 8:00 PM on Tuesday, November 6, 2007

Location:
Amgen Inc.
Building 24 Conference Center Auditorium
1 Amgen Center Drive
Thousand Oaks, CA 91320

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

Agenda:

  1. 6:00 PM – 6:10 PM Registration and Refreshments
  2. 6:10 PM – 6:15 PM Welcome and Introduction
  3. 6:15 PM – 7:15 PM The Quality Metrics: Dashboards and Scorecards
  4. 7:15 PM – 7:30 PM Questions and Answers
  5. 7:30PM – 7:35 PM Concluding Remarks
  6. 7:35PM – 8:00 PM Networking

For more information about this meeting, please contact the Chapter Chairperson:
Ana Sharma, MPH, CCRP
Compliance Manager
Global Clinical Quality Assurance
Research and DeveloPMent
Amgen Inc.

Telephone: 805.313.6264

E-mail: arsharma@amgen.com

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China, Hong Kong SoCRA Chapter

Chapter Chairperson:
Maria Ming Po, LAI, CCRP
Nursing Officer/Executive Officer

Office Address:
Centre for Clinical Trials
Room 502, 5th Floor
School of Public Health
Chinese University of Hong Kong
Prince of Wales Hospital
Shatin, New Territories
Hong Kong
China, SAR

Tel. no.: (852) 22528715

Fax.no.: (852) 26467297

Email address: maria@cct.cuhk.edu.hk

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Colorado SoCRA Chapter

Dear Colleagues,

Supplemental Education Meeting – Friday, September 14, 2007

Agenda: Palliative Care (1 CEU)

Speaker: Heather Coats, APRN, MS, OCN

Time: 12:00-1:00 PM

Location:
Anschutz Outpatient Pavilion (AOP)
Room 1603

For additional information please contact Kathryn Breaker.
kathryn.breaker@uchsc.edu
(720) 848-0651

Area map and Fitzsimons campus map

Area Map

Fitzsimons Campus Map

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Connecticut SoCRA Chapter 

We are pleased to announce another educational seminar hosted by the Connecticut Chapter of the Society of Clinical Research Associates (SoCRA).

We are pleased to announce another education program and chapter meeting sponsored by the Connecticut Chapter of the Society of Clinical Research Associates and co-provided with Hartford Hospital and Connecticut Children’s Medical Center.

Date: Thursday, May 22, 2008

Time:

  • 5:00 - 5:30 pm Registration & light supper provided
  • 5:30 - 6:30 pm Presentation & Discussion

Location:
Hartford Hospital
85 Jefferson Street Medical Building Conference Room 118

Seminar Theme: “Quality Care in Oncology – Raising Awareness and Increasing Participation in Clinical Trials”

Presented by:
Marianne Davies, APRN
Yale-New Haven Hospital

The talk objectives are:

  • Describe the value of oncology clinical trial
  • Assess current rates of clinical trial accrual
  • Identify patient and clinician barriers to patient participation
  • Discuss strategies for overcoming barriers and increasing participation rates.

Please Pre-Register by completing the attached form and returning it to Bertha Robbins, RN, CCRP at Brobbin@ccmckids.org by May 20th.

*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

DSMB and CEC: A Compare and Contrast of Value Added Services in Clinical Trials

Presented by: Sara Strickler, MD, RAC and Laura Hiles, RN, BSN, CCRN, CCRA
MED Institute

Tuesday, May 20, 2008

  • 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).

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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: February 9, 2008

Time: 10:00 - Noon

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

Topic: Creating Auditable Source Documents

Presenter: Sarah Wilson, CCRP

Please share meeting date and time with your colleagues.

RSVP to gasocrainfo@yahoo.com by February 5, 2008 is requested.

The restaurant will collect $10 for brunch from all attendees.

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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

Sue Moore, CCRP
902 473 4128
F - 902 473 6599
sue.moore@cdha.nshealth.ca

Lisa Julien, RN, BScN, CCRP
902 743 7883
lisa.Julien@cdha.nshealth.ca

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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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Illinois - Zion SoCRA Chapter

Susan Mueller, RN, CRA

Work is progressing on the formation of a SoCRA chapter, which would make it convenient for members in the Chicago and Milwaukee areas to attend local educational seminars. The goal is to provide educational opportunities for all clinical research professionals. Additionally, a network of clinical research contacts will be developed to aid researchers in their day-to-day activities.

The first meeting is tentatively planned for August at the Midwestern Regional Medical Center in Zion, Illinois.

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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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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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New Jersey SoCRA Chapter

Chapter Chairperson:
Yavuz S. Silay, MD, CCRP
(P) 201 427 8717
(F) 201 427 8400
E-mail: drysilay@yahoo.com

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New Mexico SoCRA Chapter

Date: Wednesday, July 9, 2008

Time: 6-7:30 PM

Location:
Lovelace Healthcare Center-Gibson Campus
West Classroom, Education Building
5400 Gibson Blvd SE
Albuquerque, NM 87108

Agenda: Guest Lecture followed by short Chapter updates

Guest Lecturer:
Elizabeth Burki, PhD, Clinical Research Coordinator
Lung Cancer Study, Lovelace Respiratory Research Institute,
Albuquerque, NM

Topic: Getting Down to the Basics: The Shaping of Our Ethical Selves in Every-day Life and in Every-day Research

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 City SoCRA Chapter

Invitation for all those interested in attending the first New York City SoCRA Chapter Meeting.

September 19, 2006
12 noon to 1PM

“Research Ethics”

Guest Speaker: Kathleen E. Powderly, CNM, PhD, M.Phil., MSN
Director, Humanities in Medicine

Location:
Radiation Oncology Conference Room
450 Clarkson Ave, Box 1211
Brooklyn
NY 11203

R.S.V.P:
Dr. Fazal Hussain
Phone: (718) 270-1594
Fax: (718) 270-1535
No registration fee.

Light refreshments (soft drinks/sandwiches) will be served.

Directions: (www.downstate.edu/new%20directions/suny%20directions/dir3.htm)

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New York State SoCRA Chapter

New York State SoCRA Chapter Spring Education Program Announcement

The NYS SoCRA Chapter Spring Education Program to be held May 7th, will also be hosting CCRP Prep Course (May 8) & CCRP Exam (May 9)

Save the Date!

The NYS SoCRA Chapter will be holding their day long education program on May 7th at the beautiful Welch Allyn Adirondack Lodge in Skaneateles Falls, NY.

Topics will include IRB process (including the new FDA clinicaltrials.gov registry regulation), source documentation and electronic records, everything you need to know about blood pressure, infectious disease and cross contamination and other topics which are in process.

Rooms have been blocked for this program at the noted Mirbeau Inn & Spa in Skaneateles at the great rate of $129 (Welch Allyn Corporate Rate)! Room blocks end on March 23rd.

If you would like to receive the program schedule and registration form for this program, please contact Kathi Durdon at: durdonk@welchallyn.com.

In conjunction with the NYS SoCRA Chapter spring program, we will also be hosting the SoCRA Certified Clinical Research Professional (CCRP) Prep Course on May 8th and Exam on May 9th. These two offerings need to be registered directly through SoCRA:
Certification Prep Course: Click Here.
Certification Exam: Click Here.

PLEASE NOTE: THE DEADLINE TO REGISTER FOR THE CCRP EXAM AT THIS LOCATION IS: MARCH 28!!!

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North Carolina (East) SoCRA Chapter

The July meeting has been cancelled.

The AUGUST chapter meeting will be held on Monday, 4 August 08 (6:00-7:00 PM), at Cato Research.

OUR AUGUST MEETING TOPIC: Legally Effective Informed Consent: What it Means and How to Obtain It

SPEAKER: Cheryl L. Byers, MHA, CIP

Additional information regarding the August 4th meeting will be forwarded to your attention.

Happy Fourth of July Holiday !

Joyce Arnold-Avant, CCRP (SoCRA)
Project Coordination

Cato Research / Durham
Westpark Corporate Center
4364 S. Alston Ave.
Durham, NC 27713
www.cato.com

Please share this announcement with your colleagues.

CATO is located at 4364 S. Alston Ave. (Westpark Corporate Center) All attendees should park and enter through the back of the building. The meeting will be held in the 3rd floor Auditorium, from 6:00-7:00 PM.

Please sign in at the reception desk and take the elevator to the 3rd floor. Exit the elevator to your left and follow the arrows to the Auditorium straight ahead. Upon entering the Auditorium, please sign the SoCRA attendance sheet.

Directions to Cato Research

From Raleigh/RDU Airport to Cato Research:

  1. Take Interstate 40 WEST (toward Chapel Hill) to Exit 278 (Apex 55/54)
  2. Drive straight through the stoplight, over the railroad tracks, into WESTPARK CORPORATE CENTER (The Waffle House will be on the left and the Fairfield Inn will be on the right)
  3. Drive around to the back of the office building to locate parking

Directions from Greensboro/Chapel Hill to Cato Research:

  1. Take Interstate 40 EAST toward Durham/Raleigh to EXIT 278 (Apex 55/54)
  2. Drive under the bridge and turn RIGHT at the next traffic light
  3. Drive over the railroad tracks, into WESTPARK CORPORATE CENTER (The Waffle House will be on the left and the Fairfield Inn will be on the right)
  4. Drive around to the back of the office building to locate parking

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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

E-mail: angela.rock@welchallyn.com

Telephone: 503.490.8381

Fax: 971.275.1867

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Ottawa, Ontario Canada SoCRA Chapter

Presentation: Type 2 Diabetes and Heart Disease

Speakers:

  • Colette Favreau RN, BA, CCRP- Bari 2D Study
  • Tina Leech B.A.Sc.,RD - Accord Study
  • Kathy Stevenson BN, RN - Origin Study

Tuesday June 3 2008@ 17:00

Location:
Riverside Campus
1967 Riverside Drive, Ottawa, Ontario
4th Floor – Classroom B - Room 4 – 73
(Turn left coming off the elevators and then turn right down the hall. Classroom is on the left side of the hallway)

Contact Information: Gwen Ewart RN CCRP

Telephone: 613-798-5555#19233

Email: gewart@ottawaheart.ca

Please share this announcement with your colleagues.

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Pennsylvania / Delaware Valley SoCRA Chapter

PA/Delaware Valley SoCRA Chapter
Cordially Invites You to Attend the
Educational Program, "Overview of the Drug DeveloPMent Process"

Wednesday, October 25, 2006
4:00 PM – 5:30 PM

Speaker:
Maureen. A. Morgan, MS
Director, Clinical Research Management Office
Kimmel Cancer Center
Thomas Jefferson University

Place:
Thomas Jefferson University
Bluemle Life Science Building (BLSB) Rooms 105-107
233 S. 10th Street- (Corner of 10th and Locust Street)
Philadelphia, PA 19107

Objectives of the Presentation:

  • To gain an understanding of the “big picture” of drug develoPMent
  • To gain an understanding of how and where clinical trials fit into the overall drug develoPMent process
  • To gain an understanding of both the sponsor’s and FDA’s role in drug develoPMent

Light refreshments will be served.

There is no charge for this program.

Please RSVP by October 20, 2006

Craig Pfister (215) 707-3106 E-mail: cpfister@temple.edu

Kelly Lattanzi (215) 707-8846 E-mail: Lattankm@tuhs.temple.edu

Qualifies for 1 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

June Meeting Has Been Cancelled due to speaker cancellation

GTA SoCRA Chapter to Resume Education Session in Fall 2008.

Have a good summer!

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Tennessee, Mid-South SoCRA Chapter

First Meeting

Tuesday, February 12, 2008

12:30-1:30

St. Jude Auditorium

RSVP: Janie Gardner at
janie.gardner@stjude.org
by Thursday, February 7.

Drinks will be provided.

Featured Speaker:
Clinton D. Hermes, JD
St. Jude Children’s Research Hospital
Senior Vice President
General Counsel

Topic:
Tissue Repository

Speaker will present: Implications for HIPAA on human tissue repositories; Ownership of tissue; Consent of tissue collection; Learn when IRB approval is needed to do research on human tissue; and Learn when IRB approval is needed to maintain a tissue repository.

**Please share this announcement with your colleagues**

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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

Hot Topics in Clinical Research

Jointly Sponsored by

  • Texas Tech University Health Sciences Center Division of Clinical Research
  • Human Research Protection Office and the Office of Continuing Medical Education
  • The West Texas Chapter of the Society of Clinical Research Associates (SoCRA)

Ensuring Confidence in the Conduct of Clinical Research: An FDA Perspective

Presented by:
David Lepay, MD, PhD
Senior Advisor for Clinical Science
Science/Health Coordination and International Programs
Office of the Commissioner, US FDA

Monday, July 23, 2007 – TTUHSC ACB 120

Time Change
5:00 – 6:00 PM

Refreshments will be served.

In Lubbock, please RSVP no later than Thursday, 7/19/07 at 4:00 PM to pam.gardner@ttuhsc.edu or 743-2929

Tech Linked to Regional Campuses:

  • Amarillo - Room 4714
    Please RSVP no later than Thursday, 7/19/07 at 4:00 PM to Jane Stewart or Kathy Thomas at
    amarillo.irb@ttuhsc.edu or 806 354-5419
  • Odessa - Room 2C-41
    Please RSVP no later than Thursday, 7/19/07 at 4:00 PM to kristen.levario@ttuhsc.edu or 806 335-5265
  • El Paso - Room 235 (4:00 – 5:00 p.m. MT)
    Please RSVP no later than Thursday, 7/19/07 at 4:00 PM to lucy.herren@ttuhsc.edu or 806 783-6206

If you are a non-TTUHSC participant, please contact the local campus listed above for directions and parking instructions.

Purpose: This activity is designed to provide faculty, physicians, pharmacists, nurses and staff with current information concerning Clinical Research at TTUHSC.

Objectives: Upon completion of this program the participant should be able to:

  • describe the FDA expectations and oversight in clinical research
  • explain recent changes and challenges in clinical research
  • discuss issues impacting public confidence in clinical research and FDA strategies to enhance public confidence

Accreditation:
This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of Texas Tech University Health Sciences Center and Society of Clinical Research Associates. Texas Tech University Health Sciences Center is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to sponsor continuing medical education for physicians. Texas Tech University Health Sciences Center takes responsibility for the content, quality, and scientific integrity of this CME activity.

Credit Designation:
Texas Tech University Health Sciences Center designates this educational activity for a maximum of 1 AMA PRA Category 1 Credit(s)TM. Physicians should only claim credit commensurate with the extent of their participation in the activity. Texas Tech University Health Sciences Center Office of Continuing Medical Education presents this activity for educational purposes only. Participants are expected to utilize their own expertise and judgment while engaged in the practice of medicine. The content of the presentations is provided solely by presenters who have been selected for presentations because of recognized expertise in their field.

SoCRA Credit:
Program attendees may be credited for 1 hour of Continuing Education Credit Hours from the Society of Clinical Research Associates (SoCRA).

Faculty disclosure statements have been requested from the speaker(s) and will be presented at the activity.
Persons with disabilities who may need auxiliary aids or services must submit a written request to the TTUHSC Office of CME, so that appropriate arrangements, if any, can be made. If a written request is not received at least one week prior to the program date, individuals are responsible to hire and pay for their own auxiliary aids or services.
TTUHSC reserves the right to cancel this activity or substitute speakers in the event of unforeseen or extenuating circumstances.
CME information also available on web site www.ttuhsc.edu/cme

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Tokyo, Japan SoCRA Chapter

SoCRA Japan Chapter will present the following seminar in Tokyo, Japan.

Place: Special Meeting Room, Administration Building 1st Floor National Cancer Center
Tokyo, Japan
Refer to www.ncc.go.jp/jp/ncch/ncchmap2.html

Date: Friday, June 29, 2007

Time: 18:30-20:30

Program:
What is a genomics research?
-through the Millennium Genetic Project-

Emi Toshiro, M.S., R.N.
Clinical Research Coordinator
The Center for Medical Genomic,
National Cancer Center Research Institute

CCRP Credit: 2.0 CE Credit Hours

Target Audience:
SoCRA Regular Member
Personal Support Member (Limited to the member)
Corporate Support Member (Max 2 persons per 1 contribution)

Participation Fee: Free

Please address any questions to:
SoCRAJapan_Office@umin.ac.jp

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Toronto, Canada SoCRA Chapter (Greater Toronto)

Greater Toronto Area Chapter presents:
Super Cells: Clinical and Regulatory Development in Cell Therapy

Speaker: Wanda Opera, Cell Therapy Program Manager, Princess Margaret Hospital

Date: Thursday, May 15, 2008

Time: 5:30pm-7:00pm

Location:
PMH Auditorium 6-605
Princess Margaret Hospital
Toronto, Ontario

Please bring your refreshments

Contact Persons:

Tel: (416) 946-4501 #4502

RSVP via voicemail

SoCRA CE credit: 1 hour

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Vancouver, Canada SoCRA Chapter

Includes Pacific Northwest - British Columbia, Washington; in cooperation with CRPBC.

Two meetings to announce (these educational meetings are open to non-SoCRA members to attend):

1) Vancouver SoCRA Chapter Meeting Thursday, April 3, 2008

RSVP to reserve your seat to: erin@gcpconsultants.com

Date:Thursday, April 3, 2008

Time: 5:00 pm, presentation begin at 5:30 pm

Chair: Erin Cherban, MSc, CCRP
Senior Clinical Project Manager, Global Client Partners Consulting

Topic & Guest Speaker:
Academic Research: The Clinical Site's Perspective
Cheryl Davies
Clinical Trials Coordnator
Centre for Clinical Epidemiology and Evaluation, VCHRI Clinical Research Unit

Location: QLT Inc., 887 Great Northern Way, Vancouver, BC

By attending this meeting you will be provided with a certificate that counts as 1.0 CE toward SoCRA re-certification.

2) Vancouver SoCRA Chapter members are invited to join the Providence Health Care Research Institute Clinical Coordinators Network for their April 8 Meeting.

By attending this meeting you will be provided with a certificate that counts as 1.5 CEs toward SoCRA re-certification.

RSVP to reserve your seat to: erin@gcpconsultants.com

Date:Tuesday, April 8, 2008

Time: 9:00 to 11:00 am (9:00 -10:00 Dr. Toward's presentation, 10:00-11:00 Networking and Open Discussion)

Chair:
Jacqui Brinkman, Education Coordinator and Privacy Facilitator,
The James Hogg iCAPTURE Centre for Cardiovascular and Pulmonary Research

Topic & Guest Speaker:
Preparing for a Health Canada Audit
Jeffrey Toward, Ph.D.
Continuing Review Manager, Research Ethics

By attending this meeting you will be provided with a certificate that counts as 1.0 CE toward SoCRA re-certification.

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Washington SoCRA Chapter

Washington State Chapter meeting

Date: Monday, August 28, 2006

Speaker: Gail Broder, MHS
Community Education Domestic Projects Manager
HIV Vaccine Trials Network
Fred Hutchinson Cancer Research Center

Title: Introduction to Preventive HIV Vaccine Research

CCRP CEU: 1 hour of SoCRA Continuing Education Credit

Time: 5:30 – 6:30 PM

There will be a brief discussion following the presentation regarding future meeting topics. Please bring suggestions.

Location: Metropolitan East Tower
1730 Minor Ave.
Room 1770 (17th Floor)
Seattle, WA

Parking: Available at the Metropolitan East Tower parking garage entering from Minor Street. There are also a number of surface lots and metered street parking in the immediate vicinity

RSVP: Merle Witter, CCRP mtwitter@comcast.net

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

Date: Wednesday June 11, 2008

Time:

  • 5:30 pm Meet and Greet
  • 6:00 pm Speaker presentation

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

Room:
Training Room A Floor 2 E

RSVP: mcdon@gwu.edu

Presentation: Multimedia Informed Consent: Why and How.

Summary:
The consent process has as its end point the participants understanding of their involvement in a trial and their participation decision. We will discuss current issues and trends that may lead to use of electronic media, work though a case example and think about how a new technology (computer signatures) can be used for the consent process.

Learning points:

  • Identify current trends in literacy and technology use.
  • List factors that should be considered when thinking about media based consent.
  • Understand the work flow for use of computer based signatures with online consent.

Presenters:

Susan Brink, President & CEO, ConsentSolutions, Inc.

Dr. Brink founded ConsentSolutions, Inc in 2005 to further the development of media-based approaches to informed consent for clinical trials. Susan has over 25 years experience in research and development in the area of patient and consumer health information. Dr Brink has served as the Principal Investigator on numerous NIH grants exploring technology approaches to engaging patients and consumers in health care decision-making. Dr Brink holds a DrPH from the University Of Texas School Of Public Health and a MS in Health Administration from the University of Colorado.

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.

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Wisconsin SoCRA Chapter

Research: Working as a Team

Date: Saturday, September 22, 2007

Place:
Mid-State Technical College
Marshfield, Wisconsin

Time: 7:30 A.M. – 4:00 P.M.

Sponsored by:
Marshfield Clinic Research Foundation-Clinical Research Center
Mid-State Technical College
RxTrials, Inc.

PROGRAM

7:30 A.M. – Registration & Continental Breakfast

Program A

8:25 A.M. - Welcome

8:30 A.M. -Public Perception of Clinical Research; How It Impacts Enrollment and How to Utilize This Information to Meet Your Enrollment Goals

Christine Pierre, RN

11:30 A.M. - Lunch Provided

12:30 P.M. -Genetics in Research: Perspective from a Genetic Counselor

Christina Zaleski, MS, CGC

1:30 P.M. - Role of the Principal Investigator in Clinical Research

Adedayo A Onitilo, MD, MSCR, FACP

2:30 P.M. - Stress Management in the Workplace and In Your Life

Tracy Olson, MSW, LCSW

3:30 P.M. – Closing Remarks

4:00 P.M. - Program Concludes

Special Notes

  • You do not need to be a SoCRA member to attend.
  • Conference is running in conjunction with SoCRA certification exam (please see SoCRA web site @ www.socra.org for information and registration for exam).
  • Half day registrations are permissible.

Program B

8:25 A.M. - Welcome

8:30 A.M. -Role of the Principal Investigator in Clinical Research

Adedayo A Onitilo, MD, MSCR, FACP

9:30 A.M. -Genetics in Research: Perspective from a Genetic Counselor

Christina Zaleski, MS, CGC

10:30 A.M. - Stress Management in the Workplace and In Your Life

Tracy Olson, MSW, LCSW

11:30 A.M. - Lunch Provided

12:30 P.M. -Public Perception of Clinical Research; How It Impacts Enrollment and How to Utilize This Information to Meet Your Enrollment Goals

Christine Pierre, RN

3:30 P.M.– Closing Remarks

4:00 P.M. - Program Concludes

LEARNING OBJECTIVE:

For participants to obtain a better understanding of the research team

FACULTY:

Tracy Olson, MSW, LCSW
Clinical Social Worker
Marshfield Clinic, Marshfield Center

Adedayo A Onitilo, MD, MSCR, FACP
Oncologist/Hematologist
Marshfield Clinic, Weston Center

Christina Zaleski, MS, CGC
Senior Genetic Counselor
Marshfield Clinic, Marshfield Center

Christine Pierre, RN
President
RxTrials, Inc.
www.rxtrialsinc.com

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.

REGISTRATION:

Although there is no registration fee for this program, advanced registration is required. Registration is limited. Please include which program you wish to attend. Registration deadline is Friday, September 7, 2007.

Attire:

Casual attire is appropriate for this conference.
Since meeting room temperatures and personal comfort levels vary, it is recommended that you bring a sweater or jacket to the educational activities.

Contact Hour Statement:
SoCRA designates this activity for up to 6.0 contact hours (1.0 CEUs per contact hour)

Sponsored by:
This program is sponsored by Marshfield Clinic Research Foundation-Clinical Research Center, Mid-State Technical College, and RxTrials, Inc.

FURTHER INFORMATION:

  • For more information, please call Mary Spindler, LPN, CCRP
  • WI SoCRA Chapter Chairperson (715-387-9444) or Wendy Foth, CCRP
  • WI SoCRA Planning Committee Member (715-389-7549)

To register:

Email or call Mary Spindler, LPN, CCRP at spindler.mary@mcrf.mfldclin.edu (715) 387-9444

Or

Wendy Foth, CCRP at Foth.wendy@mcrf.mfldclin.edu (715) 389-7549

Please include name, employer, email address and program choice.

Program slots will be filled on a first come basis.

Confirmation:

Confirmation of registration will be via email.

Special Accommodations:

If you are in need of special accommodations, please advise us when you register. All requests are kept confidential.

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