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)