Clinical Research Coordinator Associate
Stanford University · Stanford, California, United States · hybrid
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.
Minimum Education and 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.
Certificates and Licenses Required
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
[REMOVE STATEMENT BEFORE POSTING - KEEP LANGUAGE BELOW, IF
APPLICABLE. REMOVE IF NOT APPLICABLE]
Drivers License Requirements
- Must possess and maintain a valid California non-commercial Class
C Driver's License.
- Ability to drive day or night.
- When conducting university business, must comply with the
California Vehicle Code and Stanford University driving
requirements.