Clinical Research Coordinator

Title: Clinical Research Coordinator Associate(1472429)

Note:
Hybrid and onsite 4 days per week during training

Job Description:

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.

We strives to lead the biomedical revolution by fueling discovery and innovation to advance human health.

• 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.
• 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.