TASKS/SERVICES. The contractor shall:
(1) Develop, draft, and compile policy or procedures documents either independently or as part of a working group in support of the overall functions of the Protections of Participants, Evaluation and Policy Branch (ProPEP) in the Division of AIDS (DAIDS)
(2) Provide leadership, editorial expertise, and consultative support to the Division of AIDS through creation of clinical research policies and related procedures, as well as DAIDS human subjects clinical research policies, in compliance with all applicable US federal regulations and international guidelines, such as ICH, and other relevant guidelines.
(3) Provide DAIDS staff advice on the interpretation of human subjects’ protections regulations, protocol compliance in the area of human subject protections, and the additional requirements under 45 CFR 46 Subparts B, C, and D as well as other applicable regulations (21 CFR 50, etc.) and guidelines (ICH and others as applicable).
(4) Serve as the subject matter expert, providing expertise on HIV, associated comorbidities (such as TB), etc. needed to evaluate human subject protection issues, and maintain such scientific expertise.
(5) Contribute to the review of individual protocols presented at DAIDS’ Scientific Review Committees, from a human subject protection perspective.
(6) Provide direct human subjects protections support to protocol development teams, clinical operations offices, project specific working groups and other DAIDS and DAIDS’ Stakeholders in their oversight of the implementation of DAIDS’ sponsored and/or funded clinical research.
(7) Provide advice and develop policy briefings to inform the departmental Branch Chief and leadership of activities related to policies; perform project management, and administrative tasks related to development and/or modification of policies and procedures.
(8) Conduct in-depth research for development and/or modification of clinical research policies in a variety of areas (for example, clinical trial conduct and oversight, safety, research participant privacy protections).
(9) Provide NIH and NIAID-wide benchmarking, policy research, and analyses in support of DAIDS policy development, management, and/or administration.
(10) Serve as a content manager for the internal (ProPEP) policies and procedures and DAIDS external clinical research policy website.
REQUIREMENTS. The contractor must have at least:
(1) Bachelor’s degree in Biology, Public Health, Nursing, or a related discipline. Advanced degree (Master’s or Ph.D.) in relevant field preferred.
(2) Minimum of 5 years of relevant experience in the field of human subject protection and policy development.
(3) Experience with clinical research protocols and operations along with knowledge of federal regulations and guidelines
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