Clinical Trials Specialist

7 days ago

Rockville, Maryland, United States Kelly Full time
Job Title: IRB Specialist

Kelly Government Solutions is a trusted partner to the federal government and its key suppliers. We offer administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with the leading medical research center in the world. As an IRB Specialist, you will support the National Institutes of Health (NIH) in Rockville, MD, in an on-site position with a potential for a hybrid schedule.

Key Responsibilities:
  • Prepare regulatory submissions for approval to initiate clinical studies of emerging infectious diseases.
  • Conduct quality control reviews of IRB applications and all forms and documents included in the submission packets.
  • Ensure that advice and actions of VRC/CTP staff are consistent with NIAID, NIH, and DHHS goals and policy, as well as with applicable statutes, regulations, rules, guidance, and directives of the NIH IRB.
  • Use information technology/telecommunication systems for document management and document control.
  • Work in conjunction with the research nurse/study coordinator and the monitoring staff to schedule and attend monitoring visits for VRC protocols and to resolve and address findings generated during the visit.
  • Prepare regulatory files for monitoring activities and interface with site monitors who conduct reviews of VRC regulatory files.
  • Maintain the electronic and paper regulatory binders for the VRC clinical studies.
  • Responsible for the administration, coordination, and management of the CTP activities related to the NIH Institutional Review Board (IRB) and the IRB's management systems PROTECT and PROTRAK (PQS).
  • Analyze and interpret regulations, policies, and procedures and provide oral and written explanations and advice.
  • Assist in ensuring that all VRC/CTP scientists and clinicians involved in human subject research are educated in policies and procedures governing such research.
  • Create, distribute, and track all IRB submissions in support of the VRC clinical trials activities.
  • Logs all items in the tracking software used by VRC.
  • Distribute IRB memoranda to Principal Investigator and other appropriate CTP staff as needed.
  • Provide input on timelines and plans for VRC activities related to regulatory reviews.
  • Review investigators' responses to IRB stipulations for completeness and make recommendations regarding the adequacy of the response.
  • Design and modify forms, letters, and memoranda to guide initial and continuing review of protocols, to maintain efficient operations within the CTP, and to avoid delay or impediment to VRC clinical research.
  • Monitor the flow of documents in and out of the office in conformance with strict deadlines of the NIH IRB.
  • Track studies and communicate with investigators concerning the status and requirements for continuing reviews.
  • Serve as a resource concerning procedures and regulations for initial IRB submission and continuing review of clinical protocols. Inform potential investigators and advise them of the documentation and approvals they need to initiate a clinical study, based on the type, location, and complexity of the protocol.
  • Attend meetings of the CTP as well as the meetings related to the NIH IRB and work with clinical and regulatory staff to update work instructions and procedures as needed.
  • Maintain current knowledge of policies and regulations from the DHHS, FDA, OHRP, HSR, NIAID, and NIH for the implementation of clinical studies.
  • Provide input to the development and updating of CTP protocol manuals that are used as a reference for the conduct of external clinical trials.
  • Interpret, synthesize, and clarify relevant changes or proposals in NIH or VRC regulatory policy or procedures and standing policies.
  • Contribute to oversight process for all the required trainings for CTP staff members as well as required medical licenses, Curricula Vitae, and trainings for the clinical staff.
Requirements:
  • Master's degree in Life Sciences or other related discipline. Two (2) years of specialized experience plus a BA/BS degree is equivalent to a master's degree.
  • Minimum of two (2) years of experience in related field. Expertise in the fundamentals of clinical trials.
  • Experience in clinical data and regulatory management and monitoring for clinical studies.
  • Active knowledge of current regulatory and IRB requirements.

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