Senior Clinical Research Coordinator Lead Meaningful Trials

Profound Research; Carlsbad (CA); On-site; USD 85,000 - 120,000; Full time

Job summary

Profound Research seeks a Senior Clinical Research Coordinator to ensure strict site compliance with trial protocols, FDA/ICH-GCP guidelines, and regulatory requirements. The role oversees start-up activities, vendor management, patient recruitment, data collection, and adverse event reporting, while maintaining high-quality documentation and collaboration across teams.

The candidate will mentor staff, coordinate regulatory submissions to Sponsors and IRBs, and ensure timely study execution with

Qualifications

• BS/BA in Life Sciences or related discipline; 4 years as a Clinical Research Coordinator OR
• Associate degree; 6+ years as a Clinical Research Coordinator OR
• High School Graduate/technical degree; 8+ years as a Clinical Research Coordinator
• GCP certification and CCRC certification preferred

Responsibilities

• Maintain site compliance for all clinical trial activities per protocols and laws.
• Maintain knowledge of FDA regulations, ICH-GCP, SOPs, and study protocols.
• Complete required training incl. ICH-GCP and IATA.
• Lead and coordinate duties for assigned trials (start-up, vendor mgmt, recruitment, data collection, AE/SAE reporting).
• Submit regulatory documents to Sponsors and IRBs as required.
• Create patient recruitment and study execution strategies to meet timelines.
• Ensure good documentation practices across source data and records.
• Communicate effectively with stakeholders and mentor staff.

Skills

GCP certification

CCRC certification

Clinical assessments

Attention to detail

Education

BS/BA in Life Sciences or related

Associate degree

High School/technical degree

Job description

Profound Research seeks a Senior Clinical Research Coordinator to ensure strict site compliance with trial protocols, FDA/ICH-GCP guidelines, and regulatory requirements. The role oversees start-up activities, vendor management, patient recruitment, data collection, and adverse event reporting, while maintaining high-quality documentation and collaboration across teams.

The candidate will mentor staff, coordinate regulatory submissions to Sponsors and IRBs, and ensure timely study execution with