Research Associate
1 week ago
We are seeking a highly organized and detail-oriented Clinical Research Coordinator Associate to join our team at Stanford University's Department of Neurosurgery.
Key Responsibilities
- Serve as the primary contact with research participants, sponsor, and regulatory agencies, ensuring effective communication and timely resolution of issues.
- Assist with the screening, recruiting, and obtaining consent of study participants, maintaining confidentiality and adhering to regulatory guidelines.
- Review medical records and/or perform telephone or in-person interviews to gather data, as needed, and accurately document findings.
- Schedule subjects for appointments; contact participants with reminders or other requirements, maintaining a organized and efficient schedule.
- Perform clerical duties in the preparation of regulatory documents and maintenance of study regulatory binder, ensuring accuracy and completeness of records.
- Maintain subject study binders, including all forms and documents, (i.e. source data, consent forms, and master subject logs), and file all appropriate correspondence.
- Extract data from source documents and complete case report forms and electronic data capture (EDC) forms for assigned studies, resolving database queries as required.
- Collect, process and ship specimens in accordance with clinical protocol and IRB, ensuring compliance with regulatory requirements.
- Order and maintain study supplies, ensuring timely delivery and adequate inventory levels.
- Prepare, administer, and score study questionnaires and tests as assigned, performing quantitative review of forms, tests, and other measurements for completeness and accuracy.
- Participate in monitoring visits and regulatory audits, providing accurate and timely information as required.
- 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.
- Strong interpersonal skills, with the ability to work well with individuals and their families.
- Strong oral and written communication skills, with the ability to effectively communicate with research participants, sponsor, and regulatory agencies.
- Proficiency with Microsoft Office, including Excel, Word, and PowerPoint.
- Knowledge of medical terminology and regulatory guidelines, including IRB and FDA requirements.
- Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
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