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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:** Research Regulatory Specialist

**Facility:** BayCare Systems Office (Hybrid)

Responsibilities:

+ Responsible for ensuring their assigned research team members, investigators and associated portfolio of clinical research projects are in compliance with all applicable institutional, sponsor and governmental policies and laws.

+ Acts as a liaison between the sponsor, Clinical Research Operations, Institutional Review Board and internal departments/ staff to complete initial Institutional Review Board protocol submissions.

+ Submit study amendments in a timely fashion including changes to the protocol, consent forms and other study documents.

+ Prepare for and facilitate monitoring visits, ensure study regulatory files are up to date & audit ready

+ Maintain regulatory master files for industry & investigator initiated clinical trials

+ Aid in the development of protocol specific standard operation procedures, and develop & train Clinical Research Coordinators on guidelines related to consent, ethical conduct and protection of human subjects.

+ Must have extensive knowledge of FDA regulation and human subjects protection

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 & Education Requirements:

+ Required - Master's Degree in Related Field with 1 Year of Research, Regulatory, or other Healthcare Administration experience

+ Or - Bachelor's Degree in Business, Healthcare Management, Nursing or Related Field and 2 Years of Research Regulatory or other Healthcare Administration experience

+ Or - High School Diploma with 5 Years of Research Regulatory Experience

Certification

+ 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: Yes

**Shift Hours:** 7:00AM - 3:30PM; 8:00AM - 4:30PM

**Weekend Work:** None

Equal Opportunity Employer Veterans/Disabled

**Position** Research Regulatory Specialist

**Location** Clearwater:BayCare Sys Office West | Support Services | Full Time

**Req ID** null