Senior Clinical Research Coordinator - Impactful Trials

Profound Research; Riverbank (CA); On-site; USD 70,000 - 110,000; Full time

Job summary

Profound Research is hiring a Senior Clinical Research Coordinator to maintain site compliance with trial protocols and regulatory standards. You will manage regulatory submissions, training, and study startup activities, coordinating with sponsors, CROs, and vendors.

Ideal candidates have a strong background in GCP, CRCPA certification, and hands-on experience with participant visits, data collection, and adverse event reporting.

Qualifications

• BS/BA in Life Sciences or related discipline, and 4 years as a Clinical Research Coordinator, OR
• Associate degree and 6+ years as a CRC, OR
• High School Diploma and/or technical degree and 8+ years as a CRC

Responsibilities

• Maintain site compliance for clinical trial activities per protocols and regulations
• Maintain knowledge of FDA regulations, ICH-GCP guidelines, SOPs and study protocol(s)
• Complete required Profound Research training including ICH-GCP and IATA where applicable
• Lead and coordinate duties for assigned trials: start-up, vendor management, recruitment, source data review, training, regulatory documents, visits, and AE/SAE handling
• Submit regulatory documents to Sponsors and IRBs per protocol and IRB requirements
• Develop patient recruitment and study execution strategies to meet timelines
• Ensure good documentation practices across data and records
• Communicate professionally with team, sponsors, CROs, and vendors
• Mentor/train staff in trial conduct, protocol requirements, and management
• Coordinate supply collection from sponsors (lab kits, supplies, investigational products)
• Perform other duties as assigned

Skills

Attention to detail

Communication

GCP knowledge

Education

BS/BA in Life Sciences or related discipline

Associate degree

High School Diploma or technical degree

Job description

Profound Research is hiring a Senior Clinical Research Coordinator to maintain site compliance with trial protocols and regulatory standards. You will manage regulatory submissions, training, and study startup activities, coordinating with sponsors, CROs, and vendors.

Ideal candidates have a strong background in GCP, CRCPA certification, and hands-on experience with participant visits, data collection, and adverse event reporting.