• Supervisor Research Regulatory

    BayCare Health System (Tampa, FL)


    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

    **Position** Supervisor Research Regulatory

    **Location** Tampa:St Josephs | Leadership | Full Time

    **Req ID** 128335