Job Title : Clinical Research Coordinator
Location : CA 94305
Duration : 5 Months
Schedule : 8am to 5pm (Onsite)
Summary
We are seeking a Clinical Research Associate to perform duties related to the coordination of clinical studies. The incumbent will work with the team to ensure the safety and well-being of trial participants and to document related data per protocols and SCI-CTO SOPS and guidelines.
Core duties include :
- Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from start-up through close-out.
- 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.