Senior Clinical Research Coordinator: Impactful Trials

Profound Research; Lake Forest (CA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health insurance

PTO

Retirement plan

Professional development support

Job summary

Profound Research seeks a Senior Clinical Research Coordinator to oversee site activities for clinical trials, ensuring regulatory compliance and high-quality data capture. You will coordinate start-up, vendor management, recruitment, and regulatory submissions while mentoring staff and maintaining robust documentation practices.

The role requires GCP/ICH knowledge, CRP experience, and strong communication skills.

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 Clinical Research Coordinator OR
• High School Graduate and/or technical degree and 8+ years as a Clinical Research Coordinator
• Successful completion of GCP certification and Certified Clinical Research Coordinator (CCRC) certification preferred
• Experience performing clinical assessments, including vital signs, EKGs, blood draws, processing/shipping lab specimens
• Excellent attention to detail, organization, and communication with varied stakeholders

Responsibilities

• Maintain site compliance for all clinical trial activities per protocols and regulatory requirements
• Maintain working knowledge of FDA regulations, ICH-GCP, SOPs, and study protocols
• Complete required Profound Research trainings including ICH-GCP and IATA
• Lead and coordinate duties for assigned trials: startup, vendor management, recruitment, data collection, AE/SAE reporting
• Ensure submission of regulatory documents to Sponsors/IRBs per protocol and regulations
• Develop patient recruitment and study execution strategies to meet timelines
• Ensure good documentation practices across study records and source data
• Communicate effectively with coworkers, leadership, sponsors, CROs and vendors
• Mentor and train staff in trial conduct and documentation
• Track supplies from sponsors (lab kits, investigational products)
• Other duties as assigned

Skills

Clinical Trial Coordination

GCP Certification

CCRC Certification

Vital Signs & Lab Handling

Regulatory Compliance

Communication Skills

Detail-Oriented

Education

BS/BA in Life Sciences

Associate Degree

High School Diploma/Technical Degree

Job description

Profound Research seeks a Senior Clinical Research Coordinator to oversee site activities for clinical trials, ensuring regulatory compliance and high-quality data capture. You will coordinate start-up, vendor management, recruitment, and regulatory submissions while mentoring staff and maintaining robust documentation practices.

The role requires GCP/ICH knowledge, CRP experience, and strong communication skills.