CRA

Term from Clinical Trials industry explained for recruiters

CRA (Clinical Research Associate) is a key role in medical research and drug development. These professionals monitor clinical trials to ensure they follow proper procedures and maintain patient safety. Think of them as quality control specialists who travel to different research sites to check that trials are being conducted correctly. They're sometimes called "monitors" because they monitor how hospitals and research centers run their trials. This role is essential in getting new medications and medical treatments approved for public use.

Examples in Resumes

Monitored 12 research sites as CRA ensuring protocol compliance

Served as lead Clinical Research Associate for Phase III oncology studies

Conducted site initiation visits as CRA for multiple international trials

Performed risk-based monitoring as Clinical Research Associate for 8 concurrent studies

Typical job title: "Clinical Research Associates"

Also try searching for:

Clinical Research Associate Clinical Monitor Clinical Trial Monitor Study Monitor Drug Safety Associate Clinical Research Monitor

Example Interview Questions

Senior Level Questions

Q: How would you handle a serious protocol deviation at a research site?

Expected Answer: Should discuss steps including immediate documentation, reporting to sponsor/IRB, developing corrective action plans, and implementing preventive measures for future compliance.

Q: How do you manage multiple sites with different compliance levels?

Expected Answer: Should explain risk-based monitoring approach, prioritization strategies, and how to develop site-specific action plans while maintaining overall study timeline.

Mid Level Questions

Q: What is your approach to site initiation visits?

Expected Answer: Should describe preparation steps, training site staff, reviewing protocols, ensuring proper documentation, and establishing communication channels.

Q: How do you ensure data quality during monitoring visits?

Expected Answer: Should explain source data verification process, common documentation errors to look for, and how to train site staff on proper data entry.

Junior Level Questions

Q: What are the essential documents needed before starting a clinical trial?

Expected Answer: Should mention protocol, informed consent forms, IRB approval, site agreements, and regulatory documents.

Q: What is GCP and why is it important?

Expected Answer: Should explain that Good Clinical Practice is an international quality standard for clinical trials that protects patient rights and ensures reliable data collection.

Experience Level Indicators

Junior (0-2 years)

  • Basic understanding of clinical trial protocols
  • Knowledge of GCP guidelines
  • Site monitoring visit assistance
  • Data verification

Mid (2-5 years)

  • Independent site management
  • Protocol deviation handling
  • Site staff training
  • Risk-based monitoring

Senior (5+ years)

  • Multiple trial oversight
  • Complex protocol management
  • CRA team leadership
  • Strategic site relationship management

Red Flags to Watch For

  • No knowledge of GCP guidelines
  • Unwillingness to travel (role typically requires 60-80% travel)
  • Poor attention to detail
  • Lack of experience with electronic data capture systems
  • No understanding of medical terminology