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BayCare Health System · 3 hours ago

Research Regulatory Supervisor

Clearwater, FL

Full-time

Hybrid

Mid Level

3+ years exp

BayCare Health System is a network of community-based hospitals and healthcare services, seeking a Research Regulatory Supervisor to lead a regulatory specialist team. This role involves ensuring compliance with regulations, managing submissions to IRBs, and overseeing documentation for clinical trials.

Health CareMedical

Hiring Manager

Morgan Marotti

Responsibilities

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

Qualification

FDA regulationsRegulatory complianceTeam managementAnalytical skillsCommunication skillsBachelor's DegreeSOCRA certificationACRP certificationCCRC certificationProblem-solving skillsCollaboration skillsLeadership skills

Required

3 years research regulatory submissions experience

Bachelor's Degree in Business or Healthcare Management

strong teamwork

communication

regulatory knowledge and skills

leadership and team management

operational oversight

communication and collaboration

analytical and problem-solving skills

Preferred

SOCRA (Society of Clinical Research Associates)

ACRP (Association of Clinical Research Professionals)

CCRC (Certified Clinical Research Coordinator)

Benefits

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

Company

BayCare Health System

Glassdoor3.9

BayCare is a leading not-for-profit academic health care system that connects individuals and families to a wide range of services at 16 hospitals, including a children’s hospital, and hundreds of other convenient locations throughout the Tampa Bay and central Florida regions.

Founded in 1996

Tampa, Florida, USA

10001+ employees