Clinical Research Coordinator- A (Thoracic)

JOB PURPOSE:

Perform duties related to the coordination of clinical studies. Coordinate moderately complex aspects of one or more clinical studies and work under close direction of the principal investigator and/or study coordinator/supervisor

CORE DUTIES:

• Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from start-up through closeout.
• Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies.
• Coordinate collection of study specimens and processing.
• Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms.
• Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions, and ensure Institutional Review Board renewals are completed.
• Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
• Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.
• Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
• Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
• Participate in monitor visits and regulatory audits.

Education & Experience:

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.

Knowledge, Skills and Abilities:

• Strong interpersonal skills.
• Proficiency with Microsoft Office.
• Knowledge of medical terminology.
• 1283171-100-VAHRR
• 1284000-100-VAHVQ

The PTA to use is: (50% each)