Senior Clinical Research Coordinator: Lead Trials

Profound Research; Pasadena (CA); Sur place; USD 90 000 - 120 000; Plein temps

Avantages offerts par ce poste

Full benefits package

Professional development support

Career growth opportunities

Résumé du poste

Profound Research is seeking a Senior Clinical Research Coordinator to ensure site compliance with FDA regulations and GCP guidelines. You will lead trial start-up activities, manage vendors, recruit subjects, and oversee data collection and reporting, while ensuring high ethical and scientific standards.

The role requires strong documentation, communication with sponsors and CROs, and mentoring junior staff.

Qualifications

• Experience performing clinical assessments, including vital signs, EKGs, blood draws, and processing/shipping lab specimens.
• Strong documentation practices and data integrity in clinical trials.
• Familiarity with FDA regulations, ICH-GCP guidelines, SOPs, and study protocols.

Responsabilités

• Maintain site compliance for all clinical trial activities per protocols and regulations.
• Lead study start up, vendor management, and participant visits.
• Ensure timely data collection, adverse event reporting, and deviations management.
• Create regulatory documents submission to Sponsors and IRBs as required.
• Mentor and train staff in trial conduct and protocol requirements.
• Coordinate collection of regulatory documents and visit-related activities.

Connaissances

Attention to detail

Communication

GCP certification

Formation

BS/BA in Life Sciences or related discipline

Associate degree with 6+ years experience

High School diploma with 8+ years experience

Description du poste

Profound Research is seeking a Senior Clinical Research Coordinator to ensure site compliance with FDA regulations and GCP guidelines. You will lead trial start-up activities, manage vendors, recruit subjects, and oversee data collection and reporting, while ensuring high ethical and scientific standards.

The role requires strong documentation, communication with sponsors and CROs, and mentoring junior staff.