Regulatory Affairs Coordinator

4 weeks ago

Jupiter, United States Jupiter Medical Center Full time

Ranked #1 for Safety, Quality and Patient Satisfaction, Jupiter Medical Center is the leading destination for world-class health care in Palm Beach County and the greater Treasure Coast.

Outstanding physicians, state-of-the-art facilities, innovative techniques and a commitment to serving the community enables Jupiter Medical Center to meet a broad range of patient needs. Jupiter Medical Center is the only hospital in Palm Beach, Martin, St. Lucie and Indian River counties to receive a 4-star quality and safety rating from the Centers for Medicare & Medicaid Services (CMS).

Education

  • Bachelor's degree in life sciences
  • Master's preferred
Experience / Qualifications
  • Minimum of 5 years of relevant work experience related to regulatory affairs.
  • Professional certification related to regulatory affairs. If none, must be obtained within 12 months of hire.
  • Significant understanding of FDA, GCP & ICH guidelines and regulatory trends and changes.
Position Summary

The Regulatory Affairs Coordinator is responsible for:
  • Coordinates and/or completes applications for initial submission to the Institutional Review Board (IBC) for review including assisting with protocol development activities, completing required application forms, and creating consent forms to meet JMC and sponsor standards.
  • Collection of appropriate supporting documents (INDs, questionnaires, letters, investigational drug brochures, 1572s, HDE, IND compassionate, expanded access, etc.) and respond to Institutional Review Board requests.
  • Prepares applications for protocol/informed consent modification for submission to IRB; review and identify changes to be reviewed.
  • Analyze and submit unanticipated adverse events (AEs) and serious adverse events (SAEs) and deviation reports to the IRB as required by sponsors and, if appropriate, make changes to the consent form to reflect new information about adverse events; provides support to internal/external staff in completing AE or SAE reports for submission to study sponsors and IRB.
  • Conducts education and training of coordinators, physicians, and all research staff regarding ICH, GCP, CRFs and JMC SOPs related to research. Serves as information specialist and resource for regulatory, ethical and methodological questions and issues from staff.
  • Assists research team in other clinical research procedures as directed.
  • Performs other duties as assigned.

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