Sr. CRA

Responsibilities

• Lead end-to-end site management activities including start-up, monitoring, and close-out, ensuring studies are delivered on time and in compliance with GCP and regulatory standards
• Oversee site performance, maintain study tracking, and proactively identify risks with mitigation strategies to ensure quality and timelines
• Review source data and CRFs, ensure proper documentation (TMF/ISF), and maintain overall study data integrity
• Collaborate cross-functionally with internal teams and external vendors to ensure alignment and smooth study execution
• Support regulatory submissions, audit/inspection readiness, and mentor junior CRAs through training and co-monitoring

Qualifications

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related discipline
• 3+ years of CRA/clinical site monitoring experience
• Strong knowledge of ICH-GCP guidelines and regulatory requirements
• Proven ability to manage clinical sites independently across study phases
• Experience with study start-up, site selection, and monitoring activities