Clinical Study Manager

We are seeking an experienced Clinical Study Manager to oversee and manage clinical research studies conducted onsite in Boulder. This role requires a licensed Registered Nurse (RN) with hands‑on clinical research experience and a strong background in study coordination and team leadership. The ideal candidate has previously worked as a Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA) and has successfully managed research teams.

• Lead and oversee day‑to‑day operations of clinical research studies
• Ensure compliance with GCP, FDA regulations, and study protocols
• Manage study timelines, enrollment goals, and data integrity
• Supervise and mentor clinical research staff, including coordinators and support personnel
• Collaborate with investigators, sponsors, and cross‑functional teams
• Oversee regulatory documentation, IRB submissions, and reporting
• Monitor study budgets and resource allocation
• Ensure high standards of patient safety and care throughout study execution

• Active Registered Nurse (RN) license
• Minimum 3–5 years of clinical research experience
• Prior experience as a Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA)
• Demonstrated experience managing or leading a team
• Strong understanding of ICH‑GCP guidelines and regulatory requirements
• Excellent organizational, communication, and leadership skills
• Ability to work onsite in Boulder, CO (40 hours per week)