Sample interview questions: Can you discuss your experience with the preparation and submission of oncology clinical trial protocols for regulatory review?
Sample answer:
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Preparation:
- Gained comprehensive knowledge of oncology clinical trial protocols, regulatory requirements, and ethical guidelines.
- Conducted extensive literature reviews and analyzed existing data to identify unmet medical needs and establish a strong rationale for the proposed trial.
- Collaborated with multidisciplinary teams, including oncologists, biostatisticians, pharmacists, and data managers, to develop a robust and feasible protocol design.
- Drafted detailed protocols that clearly outlined the objectives, methodology, eligibility criteria, interventions, endpoints, statistical methods, and safety assessments.
- Ensured accurate and consistent formatting and referencing according to regulatory standards.
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Submission:
- Identified the appropriate regulatory agencies for submission based on the trial’s location and scope.
- Prepared comprehensive regulatory submissions that included the protocol, investigator’s brochure, informed consent forms, data collection tools, and any othe… Read full answer
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