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What are the Project Officer’s responsibilities in clinical research?

Portfolio manager -- Many Project Officer 

Project Officer
the NIH staff member designated as a Contracting Officer's Technical Representative (COTR) to coordinate the substantive aspects of an acquisition from its development through to contract award and administration. Also known as Contracting Officer's Technical Representative ( COTR ).
manage extramural research portfolios and play key scientific administrative roles in working with investigators throughout the life of an award.  This will include ensuring compliance with regulations that govern the protection of human subjects 
Human Subject
Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction 
Interaction
any communication or other interpersonal contact between an investigator and a human subject. For more information, go to definitions in 45 CFR 46.102 and full 45 CFR 46.
or intervention or through identifiable, private information. Regulations include but are not limited to human organs, tissues, body fluids, and recorded information. Term is defined differently by FDA.
in research, providing fiscal management, monitoring subject accrual, approving data and safety monitoring plans and preparing reports or documents as needed.

Scientific advocate/advisor - POs may identify scientific research agendas and moving initiatives forward.   POs may also produce original scientific papers and reports, summarize and integrate scientific findings, organize workshops and symposia and originate research initiatives.





Page Last Updated: February 2011
Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov

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