Clinical Research Coordinator 5

Avispa Technology•Stanford, CA

3d•Onsite

About The Position

A leading university is seeking a Clinical Research Coordinator 5 to coordinate thoracic clinical studies from start-up through closeout. The role coordinates moderately complex aspects of one or more clinical studies and serves as a primary contact for research participants, sponsors, and regulatory agencies. The coordinator supports study conduct, participant safety, regulatory compliance, data management, visit logistics, and budget monitoring.

Requirements

Two years of related work experience.
A bachelor's degree in a related field and a two-year college degree, or an equivalent combination of related education and relevant experience.
Proficiency with Microsoft Office.
Knowledge of medical terminology.

Responsibilities

Serve as the primary contact with research participants, sponsors, and regulatory agencies.
Coordinate moderately complex aspects of one or more clinical studies from start-up through closeout.
Participate in sponsor monitoring meetings, monitor visits, and regulatory audits.
Determine participant eligibility and gather consent according to protocol.
Assist in developing recruitment strategies.
Coordinate collection and processing of study specimens.
Collect and manage patient and laboratory data.
Manage research project databases, develop flow sheets and other study documents, complete case report forms, and ensure patient and research data are documented in appropriate files according to institutional and regulatory requirements.
Review and audit case report forms against source documents to ensure compliance with research protocols.
Prepare regulatory submissions and complete Institutional Review Board renewals.
Interact regularly with the principal investigator to ensure patient safety and proper study conduct.
Assemble study kits for study visits and monitor the scheduling of procedures and charges.
Coordinate documents, monitor expenditures and adherence to study budgets, and resolve billing issues in collaboration with finance and management staff.