Sample interview questions: How do you ensure compliance with all applicable local, national, and international regulations and guidelines?
Sample answer:
- Regulatory Knowledge: Keep updated with local, national, and international regulations and guidelines relevant to clinical trials, such as the Good Clinical Practice (GCP) guidelines, local ethical review board requirements, and regulatory agency regulations.
- Protocol Compliance: Ensure that clinical trials strictly adhere to the study protocol, protocol amendments, and approved investigational new drug (IND) application or clinical trial application.
- Informed Consent: Obtain informed consent from study participants or their legal representatives in compliance with regulatory requirements and ethical guidelines. Provide complete and accurate information about the study, risks, and benefits to ensure participants make informed decisions.
- Institutional Review Board (IRB) Submission: Prepare and submit all necessary documents for IRB approval, including study protocols, informed consent forms, and investigator brochures. Address IRB comments and queries promptly and provide any additional information required.
- Record Keeping and Documentation: Maintain accurate and complete clinical trial records, including patient medical records, study data, adverse events, and protocol deviations. Ensure compliance with data retention and archiving requirements.
- Investigator and Staff Training: Provide training to investigators and study staff on the study protocol, regulatory requirements… Read full answer
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