Research Regulatory Specialist

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