Lead, Clinical Research Associate
JobgetherNorth AmericaFull TimeHealthcare
Remotely
good clinical practice21 cfr part 11trial master fileregulatory requirementssite initiation visitssite qualification visitsroutine monitoring visitsserious adverse event
Job Description
📋 Description
- Lead and develop a team of Clinical Research Associates and contractors.
- Oversee monitoring and site management across clinical trials.
- Ensure adherence to policies, procedures, regulations, and quality standards.
- Coordinate resource allocation and manage workloads.
- Collaborate with sponsors, project managers, investigators, vendors, and teams to maintain momentum.
- Drive process improvements and maintain trial quality and timelines.
🎯 Requirements
- Bachelor’s degree in biomedical or life sciences or equivalent experience.
- Minimum 5 years in clinical operations within CRO/pharma; at least 3 years on-site monitoring.
- Demonstrated people-management experience.
- Strong knowledge of Good Clinical Practice and 21 CFR Part 11.
- Hands-on experience with trial activities: site visits, monitoring, and trial master file
- Excellent English communication and strong organizational skills.
🎁 Benefits
- Leadership development and opportunities to grow a Clinical Research team.
- Exposure to diverse trials, sponsors, and regulatory activities.
- Opportunities to influence monitoring strategy and process improvements.
- Collaboration in a supportive, integrity-driven environment.
- Professional development and knowledge-sharing opportunities.
- Travel opportunities for site visits and meetings.