Manager Human Subject Protection Program

Role Overview

The Manager Human Subject Protection Program is responsible for overseeing administrative and educational programming that promotes and supports compliance with regulations, laws, ethical principles, and professional standards that govern the responsible and ethical conduct of human subject research and activities throughout the broader research enterprise.

What You Will Do

Coordinate with external Institutional Review Boards (IRBs) and Institutional Biosafety Committees (IBCs), ensure research activities are compliant with federal, state, and local regulations, and manage projects and a team of Research Compliance Analysts (RCAs).

Why It Might Be a Fit

Requires expertise in biomedical clinical trials and academic research, research compliance, ethical principles, and the regulatory landscape surrounding human subject research. Strong organizational, communication, and leadership skills are necessary.

Requirements

• Bachelor’s degree in a relevant field (e.g., Biological/Life Sciences or other related field)
• 5 years of direct experience in clinical research or research compliance, with at least 2 years in a supervisory or management role.
• Certified IRB Professional (CIP) certification OR Certified in Healthcare Research Compliance (CHRC) (if not active, must obtain within 1 year of hire into the role)
• Excellent interpersonal and communication skills
• Strong analytical and problem-solving skills, with the ability to be detail oriented
• Solid computer skills, including proficiency with Microsoft software
• In-depth knowledge of human subject protection regulations and ethical research guidelines
• Strong organizational and project management skills, with the ability to manage multiple tasks and priorities
• Excellent written and verbal communication skills, with the ability to communicate complex regulatory requirements clearly to researchers and staff
• Strong problem-solving and decision-making skills, particularly in high-pressure situations
• Ability to work collaboratively with diverse teams, including researchers, clinical staff, legal counsel, and regulatory agencies
• Proficiency with research compliance software and databases, as well as MS Office Suite (Word, Excel, PowerPoint, etc.)

Benefits

• Comprehensive and market-competitive total rewards package
• Benefits
• Compensation
• Recognition
• Well-being offerings