Clinical Research Project/Program Management
For Project Managers, Site Coordinators, and Monitors
October 9 and 10, 2014
Lord Baltimore Hotel
20 West Baltimore St
Baltimore, MD 21202
SoCRA’s hotel room rate of $159 USD (plus applicable taxes) is available until 9/8/2014, or until the SoCRA room block is filled.
- 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 live activity for a maximum of 14.5 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
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
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.
Upon completion of the program, the attendee should be able to:
- Describe project management and basic risk management principles following PMI (Project Management Institute) guidelines (initiation, planning, execution, monitoring, controlling, and closing).
- 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. Disaster recovery and contingency planning will be discussed.
- Discuss Organizational Dynamics and psychological issues in project management to promote effective team building. Describe conflict resolution strategies; discuss approaches to work effectively with different leadership and personality styles.
- 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 contract development topic issues including: intellectual property (IP) rights, publication, indemnification, payment schedule management, clinical trial sponsor interactions and negotiations.
- Describe various international regulatory bodies and their submission processes using the US Code of Federal Regulations (FDA/OHRP) as a baseline.
- Describe Project Management of the IND and IDE, review guidance documents, forms and accountability measures designated for use by industry and academic research sponsors and sponsor investigators.
- Discuss pharmacy issues related to risk management, safety, drug accountability, drug purity, randomization, blinding and unblinding, inventory control drug & device administration, dose calibration and dose escalation schedules.
Click HERE to Register Online* Note: If you experience difficulties, please use the PDF form.
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 Program Agenda in Adobe PDF format.
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