Research Regulatory Supervisor

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Facility: Bay Care System Office

Schedule: Hybrid Schedule / Tuesday - Thursday in office;
Monday & Friday work from home

• 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 Bay Care, registers Bay Care-sponsored projects on Clinical Trials.gov, and prepares and submits IND or IDE applications to the FDA for Bay Care-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.

• Paid Time Off
• Tuition Assistance
• 401K Match and additional yearly contribution
• Annual performance appraisal and team award bonus
• Family resources and wellness opportunities
• Community perks and discounts

• Required – 3 years research regulatory submissions experience

• Required – Bachelor's Degree in Business or Healthcare Management

• 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:
  
  8:00 AM – 4:30 PM

Equal Opportunity Employer Veterans/Disabled

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