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Senior Clinical Research Associate

Abcellera • Montreal

Job Description

<p>Each of us cares about someone who will need medicines. That’s why our vision is to repeatedly beat the odds to deliver breakthrough medicines to patients that need them. We pursue truth and scientific rigour and have the courage to work at the edge of the unknown.</p> <p>We're looking for a Senior Clinical Research Associate to serve as the primary link between AbCellera and our investigative sites. You'll be trusted to safeguard patient safety and data integrity, build strong working relationships with clinical teams, and help sites run trials well. If you're energized by the complexity of study execution and want your work to directly move breakthrough medicines toward the patients who need them, we want to hear from you!</p> <p><strong>How you might spend your days</strong></p> <ul> <li>Owning a portfolio of complex investigator sites, applying independent judgment to keep timelines and study objectives on track even when challenges arise</li> <li>Executing the full spectrum of monitoring activities from site selection and qualification through initiation, routine monitoring, and close-out, applying strategic oversight to ensure regulatory compliance, data integrity, and operational excellence at every stage of the site lifecycle</li> <li>Exercising expert-level scrutiny in source data verification and documentation review, setting the standard for accuracy across regulatory files and essential documents</li> <li>Translating enrollment, retention, and data quality metrics into actionable insights, delivering timely monitoring visit reports that shape site strategy, not just document activity</li> <li>Taking ownership of investigational product accountability, ensuring rigor and safety across every assigned site</li> <li>Acting as the trusted point of contact between AbCellera and investigative sites, cultivating the kind of relationships that keep sites performing at their best</li> <li>Leading the resolution of protocol deviations, including investigations into significant or complex compliance issues that call for sound judgment under pressure</li> <li>Anticipating and escalating study risks before they become problems, driving quality standards and risk-based monitoring practices across your sites</li> <li>Serving as the go-to subject matter expert for your protocols and therapeutic areas, training and elevating site personnel performance</li> <li>Shaping the next generation of CRAs through hands-on mentorship, co-visits, and knowledge-sharing that raises the bar for the whole team</li> <li>Partnering across data management, project management, and medical teams to influence enrollment strategy, site management planning, and feasibility decisions</li> <li>Preparing investigative sites for sponsor, regulatory, and quality assurance audits, proactively identifying gaps, strengthening inspection readiness, and partnering with site teams to ensure confident and successful audit outcomes</li> </ul> <p><strong>We'd love to hear from you if</strong></p> <ul> <li>You hold a degree in Life Sciences, Nursing, Pharmacy, or a related field, backed by 10+ years of CRA monitoring experience and a proven track record managing complex clinical trials and multiple sites simultaneously</li> <li>You've mentored or trained other CRAs (preferred, not required), and enjoy helping others grow into strong monitors</li> <li>You bring extensive experience conducting site selection and site initiation visits, confidently assessing site capabilities, confirming study readiness, and setting sites up for successful trial execution from day one</li> <li>You bring advanced, hands-on command of ICH-GCP, FDA, EMA, and local regulatory requirements, applied with confidence a

Job Reference ID: CF-142832 • Posted on CloudFrame Job Scanner