Clinical Trials Coordinator – Regulatory & IRB

School of Medicine; Palo Alto (CA); In loco; USD 65.000 - 90.000; Tempo pieno

Descrizione del lavoro

School of Medicine in Stanford is seeking a Clinical Research Coordinator Associate to manage multiple research protocols at Stanford Hospital and Clinics. You will work with a clinical trials team, support IRB submissions, amendments, and renewals, and ensure regulatory compliance under HIPAA and GCP guidelines.

You will recruit, screen, and enroll subjects, obtain informed consent, collect data, and handle blood sample collection and shipment.

Competenze

• Two-year college degree and two years related work experience or a Bachelor’s degree in a related field or an equivalent combination of related education and relevant experience.
• Strong interpersonal skills.
• Proficiency with Microsoft Office.
• Knowledge of medical terminology.
• Certification by SoCRA or ACRP preferred.

Mansioni

• Serve as primary contact with participants, sponsors and regulatory agencies; coordinate studies from startup through close-out.
• Determine eligibility and gather consent; assist in recruitment strategies.
• Coordinate collection of study specimens and processing.
• Collect and manage patient and laboratory data; develop flow sheets and case report forms.
• Ensure compliance with protocols; prepare regulatory submissions and renewals.
• Assemble study kits, monitor scheduling of procedures and charges; attend monitoring meetings with sponsors.
• Monitor expenditures and adhere to study budgets; resolve billing issues with finance/management.
• Interact with principal investigator to ensure patient safety and proper conduct.
• Maintain essential documentation and reporting of data per regulatory requirements.
• Participate in monitor visits and regulatory audits.
• Other duties as assigned.

Conoscenze

Interpersonal skills

Microsoft Office

Medical terminology

Formazione

Two-year college degree

Bachelor’s degree in related field

Descrizione del lavoro

School of Medicine in Stanford is seeking a Clinical Research Coordinator Associate to manage multiple research protocols at Stanford Hospital and Clinics. You will work with a clinical trials team, support IRB submissions, amendments, and renewals, and ensure regulatory compliance under HIPAA and GCP guidelines.

You will recruit, screen, and enroll subjects, obtain informed consent, collect data, and handle blood sample collection and shipment.