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The job duties listed are typical examples of work performed by positions in this job classifications and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.
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This position will be based on the Stanford campus and is a hybrid of working on-site and working from home, subject to operational need.
The Department of Surgery, Division of Vascular Surgery at the Stanford University School of Medicine is seeking a Clinical Research Coordinator Associate to perform duties related to the coordination of clinical studies. The CRCA will coordinate moderately complex aspects of several clinical studies within the Division. The CRCA will work under close direction of the Principal Investigators as well as collaborate with research staff, clinicians, Stanford clinic staff, hospitals and other departments.
Desired Qualifications:
- Clinical research coordinator experience preferred
- Strong oral and written communication
- Strong organizational skills
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.