Sample interview questions: Can you explain any experience you have with managing and maintaining study documentation and records in accordance with regulatory requirements?
Sample answer:
Experience in Managing and Maintaining Study Documentation and Records
As a Clinical Research Coordinator, I have extensive experience in managing and maintaining study documentation and records in accordance with regulatory requirements. My responsibilities have included:
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Document Preparation and Review:
- Created, reviewed, and maintained research protocols, consent forms, and other study-related documents.
- Ensured all documentation was clear, concise, and compliant with regulatory guidelines.
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Record Keeping:
- Established and implemented systems for tracking and storing participant data, medical records, and study progress.
- Maintained accurate and complete research files, including source documents, case report forms, and study correspondence.
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Regulatory Compliance:
- Stayed abreast of relevant regulations, including the Common Rule and HIPAA.
- Conducted self-audits and inspectio… Read full answer
Source: https://hireabo.com/job/7_0_31/Clinical%20Research%20Coordinator