Clinical Research Coordinator

Clinical Research Coordinator 1501511

• Hourly pay: $35-$40/hr
• Worksite: Leading university (Stanford, CA 94305 - Hybrid)
• W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program, PSL
• 40 hours/week, 5 Month Assignment

A leading university is seeking a Clinical Research Coordinator to support the coordination and execution of clinical research studies from study start-up through closeout. This role serves as the primary liaison for study participants, sponsors, and regulatory agencies while ensuring compliance with research protocols, maintaining accurate study documentation, coordinating participant visits and specimen collection, and supporting the successful conduct of clinical trials.

Clinical Research Coordinator Responsibilities:

• Coordinate all phases of assigned clinical research studies from start-up through closeout, serving as the primary contact for research participants, sponsors, and regulatory agencies while supporting participant recruitment, screening, consent, and retention activities.
• Collect, manage, and maintain clinical research data by coordinating study visits, specimen collection and processing, completing case report forms, maintaining research databases, developing study documentation, and ensuring accurate electronic medical record documentation.
• Ensure regulatory and protocol compliance by preparing regulatory submissions, maintaining essential study documentation, completing Institutional Review Board renewals, auditing study records for accuracy, and supporting monitoring visits and regulatory inspections.
• Coordinate study operations by assembling study kits, scheduling research procedures, managing study budgets and billing issues, monitoring expenditures, and collaborating with investigators, sponsors, finance, and clinical teams to ensure successful study execution.
• Partner closely with principal investigators and research staff to ensure patient safety, adherence to study protocols, timely communication, and the successful completion of research activities.

Clinical Research Coordinator Qualifications:

• 2+ years of related clinical research experience.
• Associate's Degree plus 2+ years of related experience.
• Bachelor's degree in a related field, or an equivalent combination of education and relevant experience.
• Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) certification is preferred.
• Experience coordinating or supporting clinical research studies, including participant recruitment, informed consent, data collection, and study documentation.
• Experience with clinical data entry and electronic medical records; EPIC experience is preferred.
• Knowledge of clinical research regulations, research protocols, Good Clinical Practice (GCP), and medical terminology.
• Proficiency with Microsoft Office applications and clinical research documentation.
• Experience preparing regulatory documents, maintaining study files, and supporting monitoring visits or audits is preferred.

Shift:

• Hybrid: 3-4 days onsite.