Contract Clinical Research Associate

Responsibilities

• Ensure all activities associated with each type of site visit are completed in compliance with ICH-GCP, SOPs, Clinical Monitoring Plan (CMP), Protocol, Study Plans, Local Laws and Regulations
• Confirm every subject was consented to appropriately and met each eligibility criteria
• Interact with clinical site staff to resolve issues and address findings
• Accurately and timely report AEs, SAEs, and PDs, including any follow-up
• Complete high-caliber, on-time site visit reports and letters for each completed site visit
• Conduct site staff training / retraining
• Oversee site recruitment and enrollment metrics to ensure project timelines are on target; assist site with recruitment efforts, as requested
• Perform through IP accountability and reconciliation; oversee IP return/destruction process
• Complete ongoing review of ISF and TMF reconciliation to ensure completeness, accuracy, and inspection readiness of both files
• Assist with clinical quality metrics and PD listing review to identify trends or areas of risk
• Absorb and perform through IP accountability and reconciliation; oversee IP return/destruction process
• Assist with creation of monitoring tools and training material
• Train other CRAs and team members; may conduct oversight visits to ensure adequacy of CRAs

Requirements

• 4-year BA/BS or equivalent degree required, preferably in healthcare or scientific discipline
• Minimum of 4 years of independent monitoring experience; preference is 6+ years with experience at both CRO and Sponsor
• Rare disease or complex study experience
• Deep understanding of ICH, GCP, FDA, and other regulatory guidelines
• Strong knowledge of drug development and clinical research processes
• Familiarity with NDA process and FDA/EMA inspection experience is highly desired
• Experience in Phase II - IV clinical trials preferred
• Risk Based Monitoring, Targeted SDV, and Remote monitoring experience
• Strong technical experience with clinical trial systems (CTMS, EDC, eTMF, ePRO, eREG eSource, EMR, IRT/IXRS, etc.) with the ability to quickly learn new software and technologies
• Dependable with track record of collaborating and making an impact in team settings
• Able to interact professionally and confidently with Principal Investigators and clinical site staff
• Adept with strong prioritization skills across multiple projects
• Independent with the professional maturity and foresight to escalate immediately when needed
• Must be willing to travel 70%+