Clinical Research Associate (CRA)

Clinical GCP Monitoring Compliance Safety
Clinical GCP Monitoring Compliance Safety

Career Opportunity

Oversee multi-site trials as a CRA

As a CRA, you will monitor clinical trial sites, verify data integrity, and ensure participant safety and protocol compliance across locations.

Role Summary

You will serve as the primary liaison to trial sites, providing monitoring, training, and quality oversight to keep the study on time and compliant.

Key Responsibilities

  • Conduct site qualification, initiation, monitoring, and close-out visits.
  • Verify accuracy and completeness of source documents and eCRFs.
  • Ensure protocol, GCP, and regulatory compliance; manage CAPAs where needed.
  • Protect subject safety and ensure timely reporting of AEs/SAEs.
  • Maintain site relationships and communicate status to the project team.

Qualifications

  • Bachelor’s degree in life sciences/health field; advanced degree a plus.
  • Solid understanding of ICH-GCP, clinical operations, and documentation.

Technical Skills

  • Experience with EDC/eCRF systems, CTMS, and study documentation.
  • Risk-based monitoring familiarity and audit/inspection readiness.

Soft Skills

  • Detail-oriented, organized, and strong communicator with site teams.
  • Calm under pressure with a proactive, problem-solving mindset.
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Position Details

  • Location: Multiple Sites
  • Department: Clinical Operations
  • Type: Full-Time
  • Experience: 2–5 years (CRA)
  • Reports To: Clinical Trial Manager

Nice to Have

  • Therapeutic area experience and on-site monitoring track record.
  • Audit/inspection participation (sponsor or authority).

Frequently Asked Questions

Clinical Operations

What to expect while monitoring and engaging with sites.

Visit frequency is risk-based and protocol-dependent, aligned with ICH-GCP best practices.

Yes—hybrid approaches are used where appropriate to enhance quality and efficiency.

Yes—per policy and role level, including travel and accommodation where applicable.