**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