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 readyMaintain regulatory master files for industry & investigator initiated clinical trialsAid 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 OffTuition Assistance401K Match and additional yearly contributionAnnual performance appraisals and team award bonusFamily resources and wellness opportunitiesCommunity perks and discounts

 

Experience & Education Requirements:

Required - Master's Degree in Related Field with 1 Year of Research, Regulatory, or other Healthcare Administration experienceOr - Bachelor's Degree in Business, Healthcare Management, Nursing or Related Field and 2 Years of Research Regulatory or other Healthcare Administration experienceOr - 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