Job Description

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

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 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

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