Research Regulatory Supervisor

BayCare Health System; Clearwater (FL); Hybrid; USD 70,000 - 90,000; Full time

Benefits offered by this job

Paid Time Off

Tuition Assistance

401K Match

Annual performance appraisal and bonus

Family resources and wellness opportunities

Community perks and discounts

Job summary

A leading healthcare organization in Clearwater, FL is seeking a Supervisor Research Regulatory. This role involves supervising a regulatory specialist team ensuring compliance with regulations and overseeing regulatory submissions for clinical trials. The ideal candidate has a Bachelor's Degree in Business or Healthcare Management, along with 3 years of experience in research regulatory submissions. Knowledge of FDA regulations is critical. This position is full-time, with a hybrid work schedule during the week.

Qualifications

• 3 years of research regulatory submissions experience required.
• Extensive knowledge of FDA regulations and human subject protection.
• Certification in SOCRA, ACRP, or CCRC preferred.

Responsibilities

• Supervise a regulatory specialist team for compliance.
• Manage regulations submissions to IRBs and prepare documentation.
• Coordinate regulatory oversight and register projects on ClinicalTrials.gov.

Skills

Leadership

Regulatory knowledge

Team management

Problem-solving

Communication

Collaboration

Education

Bachelor's Degree in Business or Healthcare Management

Job description

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Supervisor Research Regulatory

Facility: BayCare System Office

Schedule: Hybrid Schedule / Tuesday - Thursday in office; Monday & Friday work from home

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.

Benefits

• Paid Time Off
• Tuition Assistance
• 401K Match and additional yearly contribution
• Annual performance appraisal 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 – CCRC (Certified Clinical Research Coordinator)

Job Details

• Location: Clearwater, FL
• Status: Full-time; Exempt
• Shift Hours: 8:00 AM – 4:30 PM

Equal Opportunity Employer Veterans/Disabled

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