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Regulatory Compliance Specialist
2 months ago
About Jupiter Medical Center
Jupiter Medical Center is recognized for its excellence in Safety, Quality, and Patient Satisfaction, serving as the premier healthcare provider in Palm Beach County and the surrounding Treasure Coast region. Our dedicated team of exceptional physicians, cutting-edge facilities, and innovative practices ensure that we meet a diverse array of patient needs. We take pride in being the only hospital in our area to achieve a 4-star quality and safety rating from the Centers for Medicare & Medicaid Services (CMS).
Educational Requirements
- Bachelor's degree in life sciences
- Master's degree is preferred
Experience and Qualifications
- A minimum of 5 years of pertinent experience in regulatory affairs.
- Possession of a professional certification in regulatory affairs is required; if not held, it must be obtained within the first year of employment.
- In-depth knowledge of FDA, GCP, and ICH guidelines, along with current regulatory trends and modifications.
Role Overview
The Regulatory Compliance Specialist will be tasked with:
- Facilitating and/or completing submissions for initial review by the Institutional Review Board (IBC), which includes aiding in protocol development, filling out necessary application forms, and drafting consent documents to align with both JMC and sponsor standards.
- Gathering essential supporting materials (such as INDs, questionnaires, letters, investigational drug brochures, 1572s, HDE, IND compassionate use, expanded access, etc.) and addressing requests from the Institutional Review Board.
- Preparing applications for modifications to protocols/informed consent for IRB submission; reviewing and identifying necessary changes.
- Assessing and reporting unanticipated adverse events (AEs) and serious adverse events (SAEs) to the IRB as mandated by sponsors, and, if necessary, updating consent forms to incorporate new information regarding adverse events; providing assistance to internal and external personnel in completing AE or SAE reports for submission to study sponsors and the IRB.
- Conducting training and educational sessions for coordinators, physicians, and all research personnel on ICH, GCP, CRFs, and JMC SOPs related to research. Acting as a resource for regulatory, ethical, and methodological inquiries from staff.
- Supporting the research team in various clinical research tasks as directed.
- Executing additional responsibilities as assigned.