Supervisor Research Regulatory

Responsibilities

• Supervise a regulatory specialist team
• Ensure compliance with regulations
• Manage regulations submissions to Local and Central IRBs
• Oversee the preparation of necessary documentation for clinical trials
• Directly coordinate regulatory oversight for human subject’s research projects
• Register BayCare-sponsored projects on ClinicalTrials.gov
• Prepare and submit IND or IDE applications to the FDA for BayCare-sponsored projects as required

Requirements

• 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

Qualifications

• 3 years research regulatory submissions experience
• Bachelor's Degree in Business or Healthcare Management
• PREFERRED: SOCRA (Society of Clinical Research Associates)
• PREFERRED: ACRP (Association of Clinical Research Professionals)
• PREFERRED: CCRC (Certified Clinical Research Coordinator)

Benefits

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