Research Regulatory Specialist

Baycare Health System • Clearwater, FL

202d

About The Position

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.

Requirements

• Master's Degree in Related Field with 1 Year of Research, Regulatory, or other Healthcare Administration experience
• Bachelor's Degree in Business, Healthcare Management, Nursing or Related Field and 2 Years of Research Regulatory or other Healthcare Administration experience
• High School Diploma with 5 Years of Research Regulatory Experience

Nice To Haves

• SOCRA (Society of Clinical Research Associates) certification
• ACRP (Association of Clinical Research Professionals) certification
• CCRC (Certified Clinical Research Coordinator) certification

Responsibilities

• Ensure compliance of assigned research team members, investigators, and clinical research projects with applicable institutional, sponsor, and governmental policies and laws.
• Act 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, ensuring study regulatory files are up to date and audit ready.
• Maintain regulatory master files for industry and investigator-initiated clinical trials.
• Aid in the development of protocol-specific standard operating procedures, and develop and train Clinical Research Coordinators on guidelines related to consent, ethical conduct, and protection of human subjects.
• Possess extensive knowledge of FDA regulation and human subjects protection.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Ambulatory Health Care Services
• Education Level: Master's degree