Position: Clinical Trial Project Manager

Start Date: ASAP

Location: North Valley, CA (80% at Sacramento Morse St. site, 20% at South Sacramento site, a 20–30-minute drive)

Contract: 6 months-1 year, M-F (40 hours/week)

Responsibilities:

• Oversee the execution of 5-6 clinical studies in their final or follow-up phases, while providing support for newer studies.
• Manage trial preparation, including organizing supplies, equipment, and investigator training.
• Lead and mentor staff to address challenges, ensuring minimal oversight is required.
• Operate effectively in limited space while managing high supply volumes.
• Ensure strict compliance with HIPAA , FDA regulations , GCP , and other regulatory requirements.
• Monitor and support studies in the dermatology , stroke , and cardiology therapeutic areas.
• Coordinate site visits, spending 80% of time at the Sacramento Morse St. location and 20% at the South Sacramento site.

Requirements:

• Bachelor’s degree in a related field.
• Proven clinical trial experience, particularly in operational roles.
• Strong knowledge of GCP , HIPAA , compliance requirements, and regulatory audits.
• Familiarity with EDC systems like Epic or RedCap.
• Experience managing high-intensity teams and complex projects.
• Ideal candidates have backgrounds from Stanford , UCSF , or UC Davis , with a proven understanding of clinical trial processes.

Preferred Skills and Experience:

• Demonstrated experience in risk-based monitoring and implementing CAPAs .
• Knowledge of regulatory audits, IRB, and SOPs.
• Strong conflict resolution and task prioritization skills.