Clinical Research Project/Program Management
For Project Managers, Site Coordinators, and Monitors
October 21 to 22, 2010
Radisson Plaza Warwick Hotel
1701 Locust Street
Philadelphia, PA 19103
Phone: 215-735-6000
WEB: www.radisson.com/philadelphiapa Reservations: hotel or 1-888-333-3333
For Hotel Reservations, please contact the hotel or
call 800 333 3333. Please mention SoCRA to receive the
hotel room rate of $159 (plus applicable taxes), available
until October 6, 2010 or until the SoCRA room block is filled. |
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Registration Fees:
- Member Fee- $655
- Non-Member Fee*- $730
* 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 14.5 Continuing Education Credits for SoCRA CE and Nurse CNE. SoCRA designates this educational activity for a maximum of 14.5 AMA PRA Category 1 Credit(s)™. Physicians should claim 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: 250
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Goal: Clinical trial project and program management incorporate a broad range of skill sets in order to plan, administer, track, evaluate and report
activities and budgets involved in the health care product development process. The goal of this program is to introduce, affirm or enhance the participant’s
understanding of the project management endeavor.
Objective: Through discussion, presentation, and interaction, this program will broaden the participants’ knowledge of the regulatory framework,
project management art and science, planning and accounting, and their attitude and aptitude for achieving successful clinical trials.
Learning Objectives:
Upon completion of the program, the attendee should be able to:
- Discuss the processes and procedures that are necessary to develop an infrastructure that will support the various tasks associated with Project
Management in Clinical Research.
- Discuss how to incorporate IRB interaction activities into a project plan, focusing on issues involved in managing multiple investigational sites.
- Describe project management and basic risk management principles following PMI (Project Management Institute) guidelines (initiation, planning,
execution, monitoring, controlling, and closing).
- Discuss how to address various psychological issues encountered by staff who are working with vulnerable and medically fragile populations.
- Describe general start up issues including; budget development, cash flow issues and solutions, billing to CMS (Centers for Medicare & Medicaid
Services), and contract management.
- Describe Electronic Data Capture and project management systems’ requirements for training research staff, utilizating Web-based systems, cost
management, data capture methodologies, monitoring best practices, data analysis capabilities and requirements, and desireable report writing
capabilities.
- Describe various international regulatory bodies and their submission processes using the US Code of Federal Regulations (FDA/OHRP) as a baseline.
- Describe the various IND and IDE guidance documents and forms designated for use by industry and academic research sponsors and sponsorinvestigators.
- Discuss issues related to risk management and safety, drug accountability, randomization, inventory control, budgeting and billing for “complex studies.”
- Explain how to plan for appropriate biosafety precautions to optimally protect the health care worker (research staff) and the research subject. during
gene therapy research.
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Click HERE to register online!
Click Here to view/print the Program Registration Form in Adobe PDF format.*
- 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 $455 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 2010 Program Agenda in Adobe PDF format.
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