Senior Clinical Research Associate

Job description

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. 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! **How you might spend your days** - Owning a portfolio of complex investigator sites, applying independent judgment to keep timelines and study objectives on track even when challenges arise - 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 - Exercising expert-level scrutiny in source data verification and documentation review, setting the standard for accuracy across regulatory files and essential documents - Translating enrollment, retention, and data quality metrics into actionable insights, delivering timely monitoring visit reports that shape site strategy, not just document activity - Taking ownership of investigational product accountability, ensuring rigor and safety across every assigned site - Acting as the trusted point of contact between AbCellera and investigative sites, cultivating the kind of relationships that keep sites performing at their best - Leading the resolution of protocol deviations, including investigations into significant or complex compliance issues that call for sound judgment under pressure - Anticipating and escalating study risks before they become problems, driving quality standards and risk-based monitoring practices across your sites - Serving as the go-to subject matter expert for your protocols and therapeutic areas, training and elevating site personnel performance - Shaping the next generation of CRAs through hands-on mentorship, co-visits, and knowledge-sharing that raises the bar for the whole team - Partnering across data management, project management, and medical teams to influence enrollment strategy, site management planning, and feasibility decisions - 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 **We'd love to hear from you if** - 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 - You've mentored or trained other CRAs (preferred, not required), and enjoy helping others grow into strong monitors - 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 - You bring advanced, hands-on command of ICH-GCP, FDA, EMA, and local regulatory requirements, applied with confidence across diverse study demands - You lead with sound judgment and strong stakeholder management skills, comfortable operating independently and making the right call with minimal oversight - You're a sharp problem-solver with strong risk assessment instincts, able to spot issues before they become obstacles - You're ready to travel to clinical sites, in Canada and in the USA, 60-70% of the time, bringing your expertise directly to where the work happens - You're bilingual (French/English) - required for Quebec sites, and a strong asset across our broader network **What we offer** In addition to base salary, we offer equity, annual bonus dependent on team and company performance, and a 6% (non-match) RRSP contribution. You will have a CAD $1,500 annual Active Lifestyle Allowance, annual vacation, professional development opportunities, and comprehensive health benefits. Scientific and technical mentorship is a priority. And you’ll find a strong sense of community and connections across AbCellera through our work, clubs, and socials. **About AbCellera** ***Creating medicines is the most important work we can do.*** We are a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology, women’s health, immunology, and oncology. We have built a platform for advancing antibody drug programs from target to clinic, and we are using it to build our internal pipeline. Today, our pipeline includes two drug candidates in clinical development, two preclinical development candidates (DCs) in Investigational New Drug (IND)-enabling activities, and more than 20 active discovery programs across multiple modalities and indications. We believe that when tenacious people share a vision and work together, they can truly have a positive impact. That’s why we hire for character and intelligence, not just for CVs or experience. We look for people with drive and energy. People we trust. People who need to know their days are being well spent. That their work really matters. In the end, our success will be measured by the impact of our medicines. **To apply** Please submit your application through our website and refer to **Job ID 23382** in your cover letter. We receive a large volume of applications and are only able to contact those who are selected for an interview. All communication from our Talent Discovery team will come from an @abcellera.com email address.