Acute Care, Analysis Skills, Certified Clinical Research Coordinator (CCRC), Clinical Research, Clinical Study Publications, Clinical Trial, Communication Skills, FDA (Food and Drug Administration), FDA Requirements, Healthcare, Healthcare Management, Home Care, Hospital, IDE (Integrated Development Environment), Investigational New Drug (IND), Leadership, Long-Term Care, Maintain Compliance, Operational Communications, Outpatient Care, Performance Reviews, Philosophy, Problem Solving Skills, Regulations, Regulatory Compliance, Regulatory Submissions, Research Administration, Research Protocols, Research Skills, Society of Clinical Research Associates (SoCRA), Team Lead/Manager, Team Player
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 that's built on a foundation of trust, dignity, respect, responsibility, and clinical excellence.
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
Equal Opportunity Employer Veterans/Disabled