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PROJECT MANAGERS

The Clinical Research Program’s (CRP) Project Managers (PMs) provide administrative support to clinical investigators either in conjunction with the provision of CRP Clinical Research Coordinator (CRC) services or as a free-standing service:

  • As part of the provision of CRP CRC services, CRP PMs oversee CRCs; review study funds and resolve errant charges; invoice sponsors; and track receipt of payments. 

  • When provided as a free-standing service, CRP project management support includes budget creation and management for new clinical research studies, study start-up support, monthly research fund review, study conduct and regulatory assistance, and oversight of study close-out. CRP PMs serve as a communication conduit when new investigators, grant managers and study staff are taking over approved protocols from departing members of the study team to ensure seamless continuation of research operations. In addition, PMs can work with investigators to respond to sponsor and internal audits and develop and implement corrective action plans.
Fee Structure:

  • CRP Project Management services are provided free of charge to investigators who contract for CRP Clinical Research Coordinator (CRC) services.  
  • If Project Management services are requested by investigators who have not contracted a CRP CRC, the first six hours of service are free of charge. Thereafter, the scope of services is negotiated with the investigator based on a rate of $50/hour.

CLINICAL RESEARCH COORDINATORS

The Clinical Research Program’s (CRP) experienced Clinical Research Coordinators (CRCs) provide day-to-day study management support including study initiation; subject screening, recruitment, enrollment and retention; managing study visits; specimen collection and processing; data entry, and regulatory document maintenance from study start-up through close-out. The CRP’s CRCs receive supplemental support from the CRP Project Managers at no additional cost to investigators. CRCs may be hired on an hourly or longer term based on individual investigator needs.

Fee Structure:

Fees are negotiated based on a rate of $41/hour.

IRB SUBMISSION AND ONGOING SUPPORT ASSISTANCE

The Clinical Research Program (CRP) also provides Institutional Review Board (IRB) submission and regulatory support to clinical investigators. The CRP’s clinical research coordinators can prepare IRB applications, work with investigators to respond to the IRB’s queries, and edit consent forms and other documents to support full and continued IRB approval of the study.

Fee Structure:

Full IRB Board Review: $3500 plus applicable overhead; IRB Expedited Review, Continuing Review applications and other regulatory submissions are negotiated based on a rate of $45/hour.