A leading university is seeking a Clinical Research Coordinator 5 to coordinate thoracic clinical studies from start-up through closeout.
Clinical Research Coordinator 5 Responsibilities:
Serve as the primary contact with research participants, sponsors, and regulatory agencies, coordinating moderately complex aspects of one or more clinical studies from start-up through closeout, and participate in sponsor monitoring meetings, monitor visits, and regulatory audits.
Determine participant eligibility and gather consent according to protocol, assist in developing recruitment strategies, and coordinate the 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 per institutional and regulatory requirements.
Ensure compliance with research protocols by reviewing and auditing case report forms against source documents, preparing regulatory submissions, and completing Institutional Review Board renewals. Interact regularly with the principal investigator to ensure patient safety and proper study conduct.
Assemble study kits for study visits, 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.
Clinical Research Coordinator 5 Qualifications:
2 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.
