The Research Regulatory Specialist is 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.
• Additional Specific Skills includes extensive knowledge of FDA regulation and human subjects protection.

Why BayCare?

Our network consists of 15 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. Our team members focus on tomorrow by achieving personal and professional success today. That's why you'll thrive in our forward-thinking culture, where we combine the best technology with compassionate service. We blend high-tech with high touch in ways that are advancing superior health care throughout the communities we serve. Our extraordinary team of 8522 nurses deliver clinical excellence and compassion that makes a difference in our patients lives every day. All BayCare hospitals have been awarded the Pathways to Excellence, which recognizes health care organizations for positive practice environments where nurses excel.

BayCare offers a competitive total reward package including benefits, paid time off, tuition reimbursement, 401k match and additional yearly contribution, yearly performance appraisals with merit increases, yearly team award bonus, community discounts and the chance to be part of an amazing team and a great place to work!

Requirements:

• Preferred Certification includes SOCRA (Society of Clinical Research Associates), ACRP (Association of Clinical Research professionals) or CCRC (Certified Clinical Research Coordinator)
• Bachelor's Degree in in Business, Healthcare Management, Nursing or related and 2 years of research, regulatory, or other healthcare administration 5 years management experience
• High School Diploma and 5 years of research regulatory experience
• Master's Degree in related field and 1 year of research, regulatory, or other healthcare administration experience