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Clinical Site Management
Clinical Site
Coordinator/Manager Program - GCP for Coordinators,
Research Associates, Study Nurses, and Site Managers
July 11 and 12, 2013
Radisson Plaza Warwick
220 South 17th Street
Philadelphia PA, 19107
Hotel phone: +1 215 735 6000
Reservations: 800 333 3333
SoCRA’s hotel room rate of $154 S/D USD (plus applicable taxes) is available until June 10, 2013 or until the SoCRA room block is filled.
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November 14 and 15, 2013
Marriott World Center
8701 World Center Drive
Orlando FL, 3281-6358
Hotel phone: 407 239 4200
Reservations: 800 380 7931
SoCRA’s hotel room rate of $146 S/D USD (plus applicable taxes) is available until October 19, 2013 or until the SoCRA room block is filled.
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Course Registration Fees:
Member Fee- $615
Non-Member Fee*- $690
* Non-Member Fees include a (non-refundable) one-year membership in SoCRA
Continuing Education Credit Hours:
SoCRA designates this educational activity for a maximum of 14 Continuing Education Credits for SoCRA CE and Nurse CNE. SoCRA designates this live activity for a maximum of 14 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Accreditation Statements:
CME for Physicians: The Society of Clinical Research Associates is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
CNE for Nurses: Society of Clinical Research Associates is an approved provider of continuing nursing education by the Pennsylvania State Nurses Association an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation. ANCC/PSNA Provider Reference Number: 205-3-A-09
SoCRA Course Series: 600
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GOAL: The Society of Clinical Research Associates (SoCRA) recognizes the continuing need for education for Clinical Research Professionals responsible for the activities at the research site or institution. The purpose of this program is to assist Site Coordinators, Research Associates, and Study Nurses in improving their skills and their understanding of the responsibilities of the Clinical Research Site. This program is designed to address all of the functions of the research site related to the Good Clinical Practices as delineated by the U.S. Code of Federal Regulations and the guidelines supported by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH Guidelines).
OBJECTIVE: The goal will be accomplished through lecture and practical application facilitated by clinical research professionals with a combined industry experience of more than 20 years. Information will be presented and discussed regarding administration of clinical trials according to FDA Regulations and International Conference on Harmonisation (ICH) guidelines as well as practical procedures and site / sponsor / CRO relationships.
LEARNING OBJECTIVES: Upon completion of this course the attendee should be able to:
- Discuss aspects of clinical trials that are governed by regulations and guidelines.
- Discuss the basic philosophy and guiding principles of clinical research GCP.
- Discuss the elements of the Informed Consent Form, the ethical principles originating in the Declaration of Helsinki, the various aspects of the informed consent process, and those special considerations that may impact the process.
- Describe the various aspects of human research protections including the ICH definitions of AEs (adverse events) and SAEs (serious adverse events) and describe the reporting requirements common to all sponsors and IRBs/IECs.
- Discuss the role of the Study Coordinator including: Submitting a protocol to the IRB; Setting up local procedures; Source documentation management and control; and Working relations with Sponsors.
- Discuss the rationale and issues surrounding the monitoring visit and the audit process from a site, a sponsor, and a regulatory perspective.
- Discuss the parameters, goals, and outcomes of audits and inspections.
- Discuss the philosophy and rationale for the development and implementation of Standard Operating Procedures.
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Click HERE to Register Online* Note: If you experience difficulties, please use the PDF form.
Click Here to view/print the Conference Registration Form in Adobe PDF.
*SoCRA REGISTRATION POLICIES/INFORMATION:
- Non member fees include a one year membership in SoCRA.
- Membership fees are processed immediately and are not refundable.
Fees are in U.S. dollars.
- Please make checks payable to “SoCRA”
- Checks must be drawn on a U.S. bank or marked “Pay in U.S. Funds”.
- Written cancellation requests received by SoCRA at least 10 business days prior to start of course may receive a $400 refund.
- We regret that refunds cannot be issued for cancellations on or after 10 business days prior to start of course.
- Taping (audio or video) is prohibited unless SoCRA’s written permission has been acquired.
- ADA - This program is accessible to persons with disabilities. Please list any special needs in the area indicated in the registration form.
- If for any reason this conference cannot be held, SoCRA is not responsible for costs incurred by attendees, such as airfares, or hotel or other reservations.
- SoCRA is an educational non-profit membership organization (corporation) - Federal Tax ID #61 1208981
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Click Here to view/print the Program Agenda in Adobe PDF format.
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Course Leader - Jacqueline Busheikin, RN
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Jacqueline Busheikin, RN, CCRP, is President of JANA Research Corporation, an independent clinical research consulting/monitoring organization established in 2001. She is a registered nurse and had been working in the field of clinical trials since 1989 as a study coordinator - specializing in Mental health, mainly schizophrenia, at the University of Calgary/Foothills Medical Centre. She was the first research coordinator at the Foothills Medical Centre and was responsible for establishing all standard operating procedures and for organizing the functioning of the unit. Ms. Busheikin has also presented numerous training and educational programs for site coordinators and clinical research monitors. |
Course Leader - Helen R. Darwin, CCRP
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Helen is President of Darwin Site Management Services, Ltd. She has 20 years experience in clinical research, having worked as an independent monitor and previously as a senior regional monitor in Western Canada for Janssen-Ortho Inc, a unit of Johnson & Johnson. Prior to that she worked as a CRA for a contract research organization. Before joining industry, she was employed for five years as a study coordinator. Helen joined SoCRA in 1991 and was the first Canadian member. She was elected to the board of directors in 1995 and was Chair of the Certification Committee from 1996 to 1998 and again from 1999 to 2000. Since that time, she served on the Board as a Director and as President of the Society. |
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