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Chapter News 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 ChapterThe 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 Location: Speaker: Speaker Title: Speaker Affiliation: Presentation: Summary: Light refreshments will be provided at the end of the tour. Please bring a friend and spread the word! CEC Available: 1 Credit Questions: Planning to Attend? Please RSVP: jjones@medicis.com California (Los Angeles) SoCRA ChapterDate: Wednesday, August 13, 2008 Time: 6:00 pm – 7:30 pm Topic: Monitoring and Auditing to Ensure Protocol Compliance and GCP Presenter: Location: 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 California (Northern CA) SoCRA ChapterWe 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) Denise Owensby (Vice Chair) Rayanne Hildreth (Education & Outreach Officer) *SoCRA members are credited with 1 hour of Continuing Education (CME or CNE). Please share this meeting announcement with your colleagues. California (Orange County) SoCRA ChapterFriday, 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: Time: 6:00-7:30 pm Topic: The Impact of Site Operations & Structure on Patient Recruitment Success Speaker: Location: 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.” California (San Diego) SoCRA ChapterMeeting Announcement Date: May 27, 2009 Wednesday Time: 6:00 - 7:00 pm Place: 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: California (San Francisco Bay Area) SoCRA ChapterWe 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:
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: * SoCRA members are credited with 1.5 SoCRA Continuing Education Unit (CEU). California (South Bay - LA to San Diego Area) SoCRA ChapterFrom 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 Alicia Martin-Santiago/Research Inquiry Coordinator Tarek Dessouky, M.D.,DIS, MBA, MPH Looking forward to meeting you all! California (Ventura County) SoCRA ChapterThe 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’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: Admission: Date and Time: Location: Parking is available in the main parking lot which is located at the intersection of Amgen Center Drive and Pauling Drive. Agenda: One Continuing Education (CE) credit will be given to SoCRA members for attending this meeting. Please share this announcement with your colleagues. Colorado SoCRA ChapterDear Colleagues, Supplemental Education Meeting: June 18th, 2009 Agenda: Cancer Prevention Research Speaker: Peter Raich, MD Time: 12:00-1:00 PM Location:
Anschutz Outpatient Pavilion,
Room 2005 For additional information please contact Sherri Wilke. Area map and Fitzsimons campus map Area Map
Fitzsimons Campus Map
Connecticut SoCRA ChapterSociety of Clinical Research Associates (SoCRA) Connecticut Chapter Meeting Wednesday, October 1, 2008
Connecticut Children’s Medical Center Featured Speaker and Topic: 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. Crossroads SoCRA Chapter - Indiana/Ohio/Kentucky/IllinoisThe Crossroads Chapter of SoCRA presents: The Prevention and Resolution of Compliance Issues – a CRA Perspective Presented by: Tuesday, January 20, 2009
Attendance is free and open to SoCRA and non-SoCRA members. Indiana University Cancer Pavilion (RT) 101 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. Florida (Central) SoCRA ChapterM D Anderson Cancer Center Orlando “Facets of Clinical Research” March 26, 2009 9:00 – 9:15 Registration & Welcome 9:15 – 10:00 a.m. “Pediatric Consent/Assent Process” 10:00 am – 10:45 "Current topics in nursing research: Older women surviving with breast cancer" 10:45 a.m. – 11:00 Break 11:00 – 11:45 a.m. “Protecting Human Subjects in Clinical Research Trials”
11:45 – 12:30p.m. “Cancer Research: Bench to Beside”
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”
2:15 – 3:00 p.m. “CRC Retention”
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. 4.5 SoCRA continuing education credit hours approved* Florida (South) SoCRA ChapterInvitation 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: 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: Telephone: 305-243-6823 E-mail: fcoleman@med.miami.edu ***There is no cost involved to attend this lecture. Georgia SoCRA ChapterDate: May 16, 2009 Time: 10:00 - Noon Place: 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 Speakers Bio: Please share meeting date and time with your colleagues. Sarah Wilson, MS, CCRP Lisa Larry-White Sharon Hyland Great Lakes SoCRA Chapter - Michigan/Ohio/WisconsinChapter Chairperson: Halifax, Nova Scotia, Canada SoCRA ChapterThe Halifax Chapter of SoCRA presents: A MONITOR’S PERSPECTIVE: “SOURCE DOCUMENTATION” December 8, 2008 - 1200 to 1315 pm Halifax Infirmary QEII Health Sciences Centre 1200 NOON – Chapter Update 1215 – 1315 – Presentation Start Guest Speaker: Please rsvp to: Sue.Moore@cdha.nshealth.ca (902) 473-4128 Halifax Infirmary: Illinois - Chicago Area SoCRA ChapterDear Colleague: The CHICAGO AREA SOCRA CHAPTER Presents a SEMINAR: Speaker: Date: Wednesday, May 19, 2004 Time: 1:15 - 4:30 PM Location: Local Chapter Business meeting will follow the
presentation. 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: Or for any other questions: 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. Kingston, Ontario Canada SoCRA ChapterWhen: Thursday September 27, 2007 Where: KGH Shea Conference Rm., Burr 1, Rm: 21-1061 Time: 6:30 PM to 7:30 PM Guest Speaker: Please RSVP: SoCRA CE credit: 1.0 Maine SoCRA ChapterThe 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: Maryland SoCRA ChapterThis 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. Location: Burke’s Café Restaurant 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 Limit: 30 participants (room capacity) so please RSVP 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. Massachusetts SoCRA ChapterThe 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: TIME: LOCATION: SPEAKER: PRESENTATION: 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 Michigan - Saginaw Bay ChapterThe 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: Featured Topic: Location: Contact information and R.S.V.P. Minnesota Southeast (SEMN) SoCRA ChapterThe SEMN SoCRA Chapter announces it's inaugural meeting. When: Monday May 18th. 5:15-6 networking 6-7 speaker Where: Speaker: Topic: The FDA is here to do what?!?! 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: Most important: 1 CEU will be offered at this meeting. Midwest Regional SoCRA Chapter (Missouri)Colleen Kilbourne-Glynn Mubai, India (Maharashtra) All IndiaAll India Chapter, SoCRA The first meeting of the SoCRA All India Chapter will be held: Sunday 21st December 2008 Location: 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. 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. Nebraska (Central Plains)In conjunction with the University of Nebraska Medical Center (UNMC) Presents two opportunities Wednesdays, June 17 and 24, 2009 June 17, 2009 Topic: FDA FORMS Facilitator: AMY FILLER-KATZ, RN, BSN Educational Objective: Certification preparation to review and discuss the following FDA forms in a group exchange environment:
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. New Mexico SoCRA ChapterDate: Wednesday, July 8, 2009 Time: 6-7:00 PM Location: Agenda: Guest Lecture & Short Chapter Updates Guest Lecturer: 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: New York State SoCRA ChapterNew York State SoCRA Chapter Education Program Announcement Saturday, May 9, 2009 “FDA Inspection – Uncovering the Mystery” “Notes to File - An Auditor’s Perspective” "Perceived Change in Nursing Practice Post Implementation of an Electronic Medical Record in a National Comprehensive Cancer Network." Catering Fee: $25.00 Suggested Hotel: Return this form and check payable to caterer “DoubleTree” by April 30, 2009 to: ~ SoCRA continuing education= 6.0 credit hours ~ North Carolina (East) SoCRA ChapterGreetings, 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:
ABOUT OUR SPEAKER: CREDIT HOURS: This program offers 1.0 SoCRA CEUs QUESTIONS:
DIRECTIONS TO DURHAM TECHNICAL COMMUNITY COLLEGE
From Lawson St., there are 2 locations to park: Location 1:
Location 2:
North Carolina (Winston-Salem/Northwest) SoCRA ChapterThe 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. North Central Regional SoCRA ChapterNorth 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:
Speaker: Paul Below, Clinical Research Consultant Time and Date: From 4:00 P.M -5:00 P.M on Wednesday April 09, 2008 Location: 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: Ohio "Northeast" SoCRA ChapterDate: Tuesday, February 12, 2008 Time: 6-8 PM (Light dinner will be provided) Location: 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 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.
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. Ohio Valley SoCRA ChapterDear 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:
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 Oklahoma SoCRA ChapterDear 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:
What we need:
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 Oregon SoCRA ChapterChapter Chairperson: Angela Rock Ottawa, Ontario Canada SoCRA ChapterWednesday April 8, 2009@ 17:00 – 18:00 Elizabeth Coletta RN CCRP 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 Pennsylvania / Delaware Valley SoCRA ChapterPA/Delaware Valley SoCRA Chapter Feature Presenter: Thursday, November 6, 2008 Thomas Jefferson University There is no charge for this program. Parking is the responsibility of the attendee. 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." Tennessee, Greater Nashville Regional SoCRA ChapterStates: Middle Tennessee/Greater Nashville, Western Kentucky Wednesday, June 25, 2009 12-1pm Room 898 PRB* Featured Topic: 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. Tennessee, Mid-South SoCRA ChapterWhen: 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)
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:
Traveling East :
Traveling North:
Traveling South:
Texas, Greater Houston/Galveston SoCRA ChapterThis 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. Texas, West SoCRA ChapterFebruary 12, 2009 5:30-7:30 PM CST TOPIC: Designing Clinical Materials for Low-Literacy Populations SPEAKER: SUMMARY: Ms. Schoessow will discuss how to design clinical trial materials for low-literacy populations. Upon completion of this presentation the participants will:
LOCATIONS:
For further information: Terry Fountain, CCRP 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. Tokyo, Japan SoCRA ChapterJAPAN CHAPTER SEMINAR ANNOUNCEMENT Date: June 27 2009 Time: 13:00 - 15:00 Location: 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. 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: 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. Vancouver, Canada SoCRA ChapterThe Vancouver SoCRA Chapter in conjunction with Fraser Health Authority are pleased to announce:a Clinical Trials Research Management Symposium Presentations & Speakers:
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: To register: Please contact Camille Viray: camille.viray@fraserhealth.ca with the following details: Vermont SoCRA ChapterDate: Wednesday, June 17, 2009 Time: 12:00-1:00 EST Title of Program: Speaker Name: Deidra Poucher, RN, BSN, MSHS, CCRC Location: 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
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:
For more information contact the Vermont Chapter Chair: Washington SoCRA ChapterWashington 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 Visit Tumor Vaccine Group Displays and Posters 5:30 pm Lab Tours 6:30 pm Presentations:
7:30 pm Panel Discussion 8:00 pm Lab Tours 9:00 pm Wrap Up Speakers Include:
CEU: SoCRA members may claim up to 2.5 hours of CEUs for SoCRA recertification. Location: Free Parking On-Site SoCRA members and non-members welcome, please invite your colleagues! This event is open to the public. RSVP: Merle Witter, CCRP Washington D.C. "National Capital Area" SoCRA Chapter
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