Supervisor Research Regulatory jobs in United States
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BayCare Health System · 1 month ago

Supervisor Research Regulatory

BayCare Health System is a network of community-based hospitals and health services promoting a forward-thinking philosophy. They are seeking a Supervisor for Research Regulatory to oversee a team ensuring compliance with regulations and managing submissions for clinical trials.

Health CareMedical

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 complianceLeadershipAnalytical skillsClinical trials documentationIND/IDE applicationsTeam managementBachelor's DegreeSOCRA certificationACRP certificationCCRC certificationCommunication skillsProblem-solving skillsCollaboration skills

Required

3 years research regulatory submissions experience
Bachelor's Degree in Business or Healthcare Management
extensive knowledge of FDA regulations and human subject protection
regulatory knowledge and compliance
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

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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.

Funding

Current Stage
Late Stage

Leadership Team

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Stephanie Conners
President & Chief Executive Officer
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Ann Marie Swindler
Vice President, Risk Management
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