Lecture Summary: Preparing for a CRA Interview

Introduction

• Discussion focus: Preparing for a Clinical Research Associate (CRA) interview, particularly focusing on regulatory knowledge.
• Importance of understanding regulatory requirements as a CRA.

Key Interview Questions from a Regulatory Perspective

Scenario 1: New Sub Investigator at a Site

• Immediate Actions Required:
  • Update Form 1572: Add the new sub investigator.
  • Collect and verify necessary documents:
    • License
    • CV (Curriculum Vitae)
    • GCP (Good Clinical Practice) training certificate
  • Ensure addition to the training log.
  • Obtain a signed financial disclosure form.
  • Consider portal access needs, though less urgent.
  • Update the Delegation of Authorities Log.

Scenario 2: Sub Investigator Leaves the Site

• Immediate Actions Required:
  • Add end date on the Delegation of Authorities Log.
  • Revise Form 1572: Remove sub investigator's name from box 6.

General Interview Preparation Tips

• Be ready for a wide range of regulatory-related questions.
• Quick thinking and timely responses are crucial in an interview setting.
• Understand the importance of proper documentation.

Good Documentation Practices (Alcoa-C)

• Key Attributes:
  • Attributable
  • Legible
  • Contemporaneous
  • Original
  • Accurate
  • Complete
• Importance of these attributes for both source documents and regulatory practices.

Conclusion

• The lecture briefly covered potential interview questions focused on regulatory aspects for CRAs.
• Understanding and preparation in these areas are essential for success in CRA roles.
• Encouragement to review and understand these concepts thoroughly.

Remember to see beyond regulatory tasks and consider broader documentation practices, like Alcoa-C, to excel in CRA interviews and roles.