Job Description

Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Kelly Government Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with the leading medical research center in the world. We are seeking an individual for a short-term project (estimated 1-2 months until late May 2025) to work as a Clinical Protocol Specialist at the National Institutes of Health (NIH) in Bethesda, MD.

KEY TASKS

(1) Provide regulatory guidance and assistance for protocol development, implementation, and continuing support for National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) intramural research protocols.

(2) Serve as the point-of-contact and project manager for an assigned portfolio of projects.

(3) Work with PIs and the research team on the design, plan, production and revision of

study documents, including applying clinical and regulatory knowledge to the review of

protocol and informed consent documents.

(4) Work with research staff to navigate requirements for protocol approval and continued conduct, which may include completing submissions to approving bodies (e.g., scientific review, IRB and radiation safety), coordinating with PIs and the research team to ensure stipulations are addressed appropriately, and tracking the required approvals necessary to initiate and continue intramural research.

(5) Prepare other program actions that do not go to the IRB such as data sharing plans, reliance agreements and technology transfer agreements.

(6) Provide advice and assistance in troubleshooting human subjects protection issues.

(7) Work with the Institutional Review Board (IRB) to keep abreast of new guidance related to protocol and informed consent submissions for both initial reviews and amendments

(8) Work with the Office of Human Subjects Research Protection (OHSRP) to keep abreast of new guidance related to policy governing the conduct of research at the NIH Intramural Research Program

(9) Maintain regulatory files, ensure protocol design safety issues are identified early, and required oversight is initiated as outlined in the protocol.

(10) Educate research staff regarding relevant aspects of regulatory process including requirements of protocol development, conduct of research trials, regulatory change, IRB and FDA submission requirements, radiation safety requirements, ethics clearances, and technology transfer.

(11) Disseminate expertise and best practices related to human subjects protections in clinical research through presentations, publications, and/or interactions with colleagues.

KEY REQUIREMENTS

(1) Master’s degree related to life science, public health or healthcare; three (3) years of specialized experience plus a bachelor’s degree is equivalent to a master’s degree

(2) Relevant clinical research experience to serve as an expert and program manager for principal investigators and other staff responsible for planning, developing, approving, implementing, and tracking research protocols

(3) Regulatory experience including mastery of the IRB process and the submission/approval process

(4) Ability to work in a clinical research regulatory setting, both independently and with a team, to coordinate, negotiate and facilitate program goals, mitigate potential problems, move projects forward expeditiously, and meet deadlines

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