Supervisor Research Regulatory

**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** Clearwater:BayCare Sys Office West | Leadership | Full Time

**Req ID** 162928