Acute Care, Administrative Skills, Certified Clinical Research Coordinator (CCRC), Clinical Research, Clinical Trial, FDA Requirements, File Maintenance, Government Funding, Government Regulations, Healthcare, Healthcare Administration, Healthcare Management, High School Diploma, Home Care, Hospital, IRB/IEC (Institutional Review Board/Independent Ethics Committee), Informed Consent, Long-Term Care, Nursing, Operations Processes, Operations Research, Organizational Skills, Outpatient Care, Performance Reviews, Philosophy, Regulations, Society of Clinical Research Associates (SoCRA), Standards Development, Time Management, Work From Home
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)
Schedule: Tuesday - Thursday in office; Monday and Friday work from home
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: No
Shift Hours: 7:00AM - 3:30PM; 8:00AM - 4:30PM
Weekend Work: None
Equal Opportunity Employer Veterans/Disabled