Research Regulatory Supervisor

Join the team that is revolutionizing health care BayCare Health System Our network consists of 16 community-based hospitals, a long-term acute care facility, home health services, outpatient centers and thousands of physicians. With the support of more than 30,000 team members, we promote a forward-thinking philosophy thats built on a foundation of trust, dignity, respect, responsibility, and clinical excellence. Title:Supervisor Research Regulatory Facility:BayCare System Office Schedule:Hybrid Schedule / Tuesday - Thursday in office; Monday & Friday work from home 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 subjects 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 Equal Opportunity Employer Veterans/Disabled