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.
BayCare offers a competitive total reward package including:
- Benefits (Medical, Dental, Vision)
- Paid Time Off
- Tuition Assistance
- 401K Match and additional yearly contribution
- Annual performance appraisals and team award bonus
- Family resources and wellness opportunities
- Community perks and discounts
Experience Requirements
- Required - 3 years research regulatory submissions experience
Education Requirements
- Required - Bachelor's Degree in Business or Healthcare Management
Certification Requirements
- Preferred - SOCRA (Society of Clinical Research Associates)
- Preferred - ACRP (Association of Clinical Research Professionals)
- Preferred - CCRC (Certified Clinical Research Coordinator)
Location: Clearwater, FL
Status: Full Time; Exempt
Shift Hours: 8:00AM - 4:30PM
Weekend Work: None
