Sample interview questions: What steps do you take to ensure compliance with oncology regulations and guidelines?
Sample answer:
- Maintain a comprehensive understanding of oncology regulations and guidelines. This includes being familiar with Good Clinical Practice (GCP), the International Conference on Harmonisation (ICH) guidelines, and the regulations of the relevant regulatory agencies (e.g., FDA, EMA, MHRA).
- Develop and implement a robust quality management system. This system should ensure that all clinical research activities are conducted in accordance with GCP and other applicable regulations.
- Train and educate staff on oncology regulations and guidelines. This training should be tailored to the specific roles and responsibilities of each staff member.
- Monitor compliance with oncology regulations and guidelines on an ongoing basis. This monitoring should include regular audits and inspections.
- Take corrective and preventive action when non-compliance is identified. This may involve implementing new… Read full answer
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