Regulatory Affairs and Compliance Administrative
DCI OFFICE OF RESEARCH SUPPORT
Provide administrative direction and coordination in meeting all Duke and National Cancer Institute [NCI] Cancer Center Support Grant [CCSG] requirements in the day-to-day activities in relation to the Duke Cancer Institute [DCI] Oncology Clinical Research Unit [CRU] and CCSG scientific reviews performed by the Cancer Protocol Committee [CPC].
Responsibilities and Expectations
Responsible for triage and initial review of all cancer-related clinical research protocols submitted in the Duke electronic Internal Review Board [eIRB] system. Studies are reviewed for conforming to Duke and NCI CCSG requirements. Assign protocols for review by CPC members.
Serve as a liaison between the Principal Investigator/s [PIs], the study team, the CPC and the Duke IRB to ensure all study submissions are completed and reviewed in a timely manner.
Responsible for Oncology Clinical Research Unit [CRU] and CPC review in the Duke eIRB system. Coordinate final CPC sign off in eIRB. Acts as the CRU sign off for new protocols and associated Research Data Security Plans (RDSPs) in eIRB.
Conduct orientation and training for all new CPC members as well as individual disease group clinical research nurses and coordinators. Orientation includes overview of CPC, CCSG and Duke requirements for submission of protocols (format, information provided), types of CPC reviews, eIRB submission and how to, who to contact, etc.
Coordinate annual scheduling of DCI representatives on the CPC and Duke IRB.
Identify problems and/or inconsistencies in individual study submissions and overall CPC review process; recommend corrective action as appropriate. Expert in protocol submission requirements (required information and application data).
Responsible for initial entry of study characteristics of all new protocols into the CPC Access database based upon study characteristics and alignment with NCI CCSG categories.
And other work as assigned.
The above statements describe the general nature and level of work being performed. This is not intended to be an exhaustive list of all responsibilities and duties required.
The intent of this position description is to be representative of the level and the types of duties and responsibilities that will be required of this position and shall not be construed as a declaration of the total specific duties and responsibilities. You may be directed to perform job-related tasks other than those specifically presented in this description.
Requisition Number 401491709
Duke Entity MEDICAL CENTER
Job Code 2857 REGULATORY AFFAIRS & COMPLIANCE ADMINIST
Job Family Level 71
Full Time / Part Time FULL TIME
Regular / Temporary Regular
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Bachelor's degree in a scientific discipline or equivalent.
Four years of clinical trials research experience, including budget preparation, NIH/NCI grant application experience and familiarity with regulatory guidelines. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
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