Supervisor Research Regulatory

• 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
• CCRC (Certified Clinical Research Coordinator)

• Location:

• Clearwater, FL

• Status:

• Full Time; Exempt

• Shift Hours:

• 8:00AM
• 4:30PM

• Weekend Work:

• None
• Equal Opportunity Employer Veterans/Disabled
• Position
• Supervisor Research Regulatory
• Location

•

Clearwater:

BayCare Sys Office West | Leadership | Full Time

• Req ID
• 128335