Stanford University and the Department of Psychiatry and Behavioral Sciences is seeking a Clinical Research Coordinator Associate (CRCA) to perform duties related to the coordination of moderate complex clinical studies. The CRCA serves as the primary contact for research participants from diverse populations, including adults with schizophrenia and children with schizophrenia or bipolar disorders. The CRCA will work under close direction of the principal investigator. Additionally, the CRCA coordinates study visits and serves as the liaison between the study sponsor and the Principal Investigator to ensure smooth communication and study operations.
DESIRED QUALIFICATIONS:
- Experience coordinating moderately complex clinical studies.
- Experience coordinating clinical studies involving adults with schizophrenia and children with schizophrenia or bipolar disorders
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.
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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.