Job Description

Job Title : Clinical Research Coordinator (1467274)

Duration: 6+ months contract(with possibility of extension)

Location: Palo Alto, CA 94304 (Hybrid)

Job Description:

• Cancer Clinical Research Coordinator Associate
• The Clinical Trials Office seeks 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.
• Client's department strives to lead the biomedical revolution by fueling discovery and innovation to advance human health.

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.

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