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["Regulatory Affairs Coordinator","Regulatory Affairs Coordinator"]

Katalyst Healthcares and Life Sciences

  • Indianapolis
  • 5 days ago

    Highlights

    They will support clinical research teams by facilitating the study start-up approval process and maintaining documentation of regulatory compliance throughout the trial's duration for research studies involving human subjects. This role ensures adherence to local, state, and federal regulations, including but not limited to FDA, ICH, and GCP guidelines, and supports the smooth conduct of clinical research studies at the site.

    Numbers & Facts

    LocationIndianapolis

    Description

    Responsibilities:
    • The Regulatory Coordinator is responsible for the coordination, preparation, and maintenance of regulatory documentation and compliance for clinical trials.
    • This role ensures adherence to local, state, and federal regulations, including but not limited to FDA, ICH, and GCP guidelines, and supports the smooth conduct of clinical research studies at the site.
    • They will support clinical research teams by facilitating the study start-up approval process and maintaining documentation of regulatory compliance throughout the trial's duration for research studies involving human subjects
    • S/he will be responsible maintaining accurate and up-to-date regulatory files.
    • S/he will serve as a central regulatory resource for staff conducting clinical research.
    • This position reports to the Director of Research Services.
    • Prepare, review, and submit regulatory documents for initial IRB submission, amendments, continuing reviews, and protocol deviations.
    • Reviews informed consents for institutional language and work with legal and sponsors to ensure CTA language is consistent with consent.
    • Maintain accurate and up-to-date regulatory binders, including signed investigator agreements, CVs, and medical licenses.
    • Develop and maintain electronic regulatory files in compliance with institutional and sponsor requirements.
    • Track protocol approvals, renewals, and amendments to ensure study compliance.
    • Monitor study compliance with federal regulations (FDA, OHRP) and guidelines (ICH, GCP).
    • Maintain site readiness for internal and external audits and inspections, including preparing regulatory files and ensuring proper documentation
    • ssist in preparing responses to audit findings and implementing corrective actions.
    • Ensure prompt and accurate reporting of adverse events (AEs), serious adverse events (SAEs), and protocol deviations.
    • Provides study updates, deviations, and SAE reports to Director of Research Services.
    Requirements:
    • Bachelor's degree required
    • Minimum of 2 years of experience in regulatory coordination within clinical research, preferably in oncology.
    • Knowledge of FDA regulations, ICH guidelines, and GCP standards.
    • Experience with IRB submissions, protocol amendments, and regulatory document management.
    • Experience working with multiple central IRBs, understanding their submission process and requirements.
    • Proficiency with electronic systems and Microsoft Office Suite.
    • Strong organizational skills, attention to detail, and ability to manage multiple tasks efficiently.

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