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Job Description
Job Details Title:
Research Regulatory Supervisor
Company:
BayCare Health System
Location:
Clearwater, FL Join the team that is revolutionizing health care•
BayCare Health System Title:
Supervisor Research Regulatory Facility:
BayCare System Office (Hybrid)
Responsibilities Include:
Responsible for supervising a regulatory specialist team, ensuring compliance with regulations, managing regulations submissions to Local and Central IRBs, and overseeing the preparation of necessary documentation for clinical trials.
This role requires strong teamwork, communication, regulatory knowledge and skills to guide the team to ensure research protocols are conducted in compliance with all regulations.
The supervisor directly coordinates regulatory oversight for human subject's research projects administratively approved for use within BayCare, registers BayCare-sponsored projects on ClinicalTrials.gov, and prepares and submits IND or IDE applications to the FDA for BayCare-sponsored projects as required.
Required skills includes extensive knowledge of FDA regulations and human subject protection, regulatory knowledge and compliance, leadership and team management, operational oversight, communication and collaboration and analytical and problem-solving skills.
Experience Requirements:
Required
3 years research regulatory submissions experience