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Regulatory Coordinator II-Research

Company: Nemours
Location: Wilmington
Posted on: November 22, 2021

Job Description:

The Regulatory Coordinator II position will be coordinate regulatory matters concerning the protection of human subjects for studies conducted within clinical research. This position will complete submissions to the Institutional Review Board (IRB) for new studies, with a particular focus on highly complex protocols including Investigational New Drugs (IND), Expanded Access and Emergent Use submissions to the FDA. The submission process includes completion of extensive, detailed forms summarizing all aspects of a research study as well as the development of new research subject consent forms. This is made possible by the Regulatory Coordinator's ability to read and interpret highly specialized research protocols, by negotiating with study sponsors and through understanding of federal regulations governing medical research. Usually acting on behalf of Principal Investigators, this position will be responsible for subsequently addressing IRB concerns, questions and requests' regarding any aspect of a clinical research study until approval is received. This position will serve as a liaison between the Principal Investigators, sponsor companies, and the IRB. This position will contribute to the development of regulatory operating policies and procedures for clinical research and provide guidance to Investigators on regulatory policies guidelines, compliance reporting, and submissions.This position will work collaboratively with a variety of personnel at all levels, including study team members at Nemours and external institutions, cooperative groups, clinical trials experts, quality, representatives from the pharmaceutical industry, federal agencies, and other research organizations.

  • Coordinates submission of regulatory documents to the IRB, including development of informed consent forms and protocol review for complex studies involving more than minimal risk to research subjects. Works independently to complete high-acuity protocol reviews with little need or no need for guidance from investigators and/or management. May prepare Compassionate Use applications, IND applications and renewals. Corresponds with the FDA throughout the IND process. Submits study renewal applications and study progress reports to the IRB
    • Interprets existing and/or new regulatory requirements, developments and Institutional Regulatory Policies as they relate to human subjects research in order to effectively communicate regulatory requirements to the research staff. Maintains current knowledge of federal and institutional guidelines and requirements governing research. Recommends and implements regulatory process improvements.
      • Prepares and participates in all internal and external program audits (monitoring visits), interacts with regulatory agents, and Sponsor monitors. Ensures regulatory binders are well maintained, organized and complete.
        • Communicates with IRB and administrative units, project sponsors and project staff to ensure accuracy of regulatory documents and submissions. Monitors study closure activities and coordinates project closeout with study sponsors, investigators and the IRB.
          • Tracks study approvals and expirations to ensure uninterrupted project approval. Maintains regulatory database and manages electronic filing of all regulatory documents.
            • Provide input and participate in continuous improvement projects and team meetings.Qualifications
              • Bachelor's degree in health related sciences
              • Certification preferred (IRB Professional).

Keywords: Nemours, Wilmington , Regulatory Coordinator II-Research, Other , Wilmington, Delaware

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