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.\nMust 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\nCommunity 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\nOr
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)\nPreferred
CCRC (Certified Clinical Research Coordinator)

Location:

Clearwater, FL Status:

Full Time;

Exempt:

No Shift Hours:

7:00AM

3:30PM; 8:00AM
4:30

PM Weekend Work:

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