Supervisor Research Regulatory

Title Supervisor Research Regulatory Facility BayCare System Office (Hybrid) Responsibilities 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. Benefits 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 Employment Type Full Time; Exempt Shift Hours 8:00AM - 4:30PM Weekend Work None Equal Opportunity Employer Veterans/Disabled #J-18808-Ljbffr