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Job Description
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:
Supervisor Research Regulatory
Facility:
BayCare System Office (Hybrid)
Responsibilities Include:
+ Responsible for supervising a regulatory specialist team, ensuring compliance with regulations, managing regulations submissions to Local and Central IRBs, and overseeing the preparation of necessary documentation for clinical trials.
+ This role requires strong teamwork, communication, regulatory knowledge and skills to guide the team to ensure research protocols are conducted in compliance with all regulations. + The supervisor directly coordinates regulatory oversight for human subject's research projects administratively approved for use within BayCare, registers BayCare-sponsored projects on ClinicalTrials.gov, and prepares and submits IND or IDE applications to the FDA for BayCare-sponsored projects as required. + Required skills includes extensive knowledge of FDA regulations and human subject protection, regulatory knowledge and compliance, leadership and team management, operational oversight, communication and collaboration and analytical and problem-solving skills.
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 Requirements
+ Required
3 years research regulatory submissions experience
Education Requirements
+ Required
Bachelor's Degree in Business or Healthcare Management
Certification Requirements
+ Preferred
SOCRA (Society of Clinical Research Associates) + Preferred
ACRP (Association of Clinical Research Professionals) + Preferred