Detailed Job Description:

Job Title: Clinical Research Coordinator

Location: Palo Alto, CA 94304 - Hybrid Role

Duration: 06 Months (Extension/Conversion based on performance)

Pay : $40-47/ hr 

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)

Description:

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

• Coordinator site experience (not pharma, CRO, or Lab research experience).
• Treatment trials experience, EPIC experience, and a like to have is oncology experience

• 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 the 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 monitoring visits and regulatory audits.