Remote Senior CRA: Phase 2–3 Trials & eTMF Quality

BioCT Innovation Commons; New Haven, Northern (CT, KY); Hybrid; USD 90,000 - 130,000; Full time

Job summary

BioCT Innovation Commons in Connecticut is seeking a Senior Clinical Research Associate to provide senior-level co-monitoring and quality oversight for clinical trials. You will partner with CRAs, CRO monitors, and cross-functional study teams to ensure site activities and study documentation meet the highest standards of quality and audit-readiness.

The role combines hands-on monitoring with ownership of eTMF quality control and trial oversight, reporting to the Director of Clinical Operations.

Qualifications

• Bachelor’s degree in life sciences or related field; advanced degree is a plus.
• 4–6 years of clinical research experience in Biotech/Pharma/CRO; Phase 2/3 experience preferred.
• Experience with eTMF systems and document quality control.
• Strong knowledge of GCP/ICH guidelines and FDA regulations.
• Experience with EDC systems and remote/risk-based monitoring.
• Experience supporting inspection readiness (FDA/EMA/audit).

Responsibilities

• Co-monitor site visits with CRAs or CRO partners to provide senior-level oversight.
• Conduct independent quality checks of monitoring reports and SDV/SDR.
• Provide real-time coaching and feedback to CRAs during joint visits.
• Assess site performance and elevate findings from visits as needed.
• Identify, document and follow up on site-level deviations and CAPAs.
• Build strong relationships with investigators and site staff; mentor juniors.
• Support oversight tasks for Phase 2 and 3 studies, including essential document reviews.

Skills

GCP/ICH knowledge

eTMF quality control

FDA/EMA regulations

Remote monitoring

Team collaboration

Education

Bachelor's degree in life sciences or related field

Advanced degree a plus

Tools

eTMF systems

RIMS platforms

EDC systems

Microsoft Office

Job description

BioCT Innovation Commons in Connecticut is seeking a Senior Clinical Research Associate to provide senior-level co-monitoring and quality oversight for clinical trials. You will partner with CRAs, CRO monitors, and cross-functional study teams to ensure site activities and study documentation meet the highest standards of quality and audit-readiness.

The role combines hands-on monitoring with ownership of eTMF quality control and trial oversight, reporting to the Director of Clinical Operations.