Senior Clinical Trials Lead & Regulatory Coordinator

Profound Research; Los Angeles (CA); Vor Ort; USD 90.000 - 120.000; Vollzeit

Benefits dieser Stelle

Health insurance

PTO

Retirement plan

Professional development support

Zusammenfassung

Profound Research seeks a Senior Clinical Research Coordinator to ensure site compliance with trials following FDA, ICH-GCP, and company SOPs. You will lead study startup, vendor management, recruitment, data collection, and regulatory submissions.

You will mentor staff, maintain quality documentation, and coordinate with Sponsors, IRBs, and CROs to support safe, effective clinical trials. On-site role in Los Angeles with travel to partner sites as needed.

Qualifikationen

• GCP certification and CCRC certification are preferred.
• Experience performing clinical assessments (vital signs, EKGs, blood draws, processing/shipping labs).
• Excellent attention to detail, organization, and communication with varied stakeholders.

Aufgaben

• Maintain site compliance with protocols, laws, regulations, and SOPs.
• Lead study startup activities, vendor management, and subject recruitment.
• Prepare and submit regulatory documents to Sponsors and IRBs as required.
• Develop patient recruitment and study execution strategies to meet timelines.
• Mentor and train staff in trial conduct and documentation practices.

Kenntnisse

GCP certification

CCRC certification

Clinical assessments

Attention to detail

Communication

Ausbildung

BS/BA in Life Sciences or related

Associate degree with 6+ years experience

High School Diploma or technical degree with 8+ years

Jobbeschreibung

Profound Research seeks a Senior Clinical Research Coordinator to ensure site compliance with trials following FDA, ICH-GCP, and company SOPs. You will lead study startup, vendor management, recruitment, data collection, and regulatory submissions.

You will mentor staff, maintain quality documentation, and coordinate with Sponsors, IRBs, and CROs to support safe, effective clinical trials. On-site role in Los Angeles with travel to partner sites as needed.