Senior Clinical Research Associate
$15,000–$25,000 year
On-siteMontréal, Quebec, Canada
Job Summary
Own a portfolio of complex investigator sites, applying independent judgment to keep timelines and study objectives on track. Execute the full spectrum of monitoring activities from site selection through close-out, ensuring regulatory compliance and data integrity. Exercise expert-level scrutiny in source data verification and documentation review. Translate enrollment and data quality metrics into actionable insights to shape site strategy. Take ownership of investigational product accountability and act as the trusted point of contact between AbCellera and investigative sites. Lead the resolution of protocol deviations and anticipate study risks before they become problems. Serve as the go-to subject matter expert, training and elevating site personnel performance. Partner with data management, project management, and medical teams to influence enrollment and site management planning. Prepare investigative sites for sponsor, regulatory, and quality assurance audits. This role requires 10+ years of CRA monitoring experience, bilingualism (French/English), and 60-70% travel to clinical sites in Canada and the USA.
Required Qualifications
- Degree in Life Sciences, Nursing, Pharmacy, or a related field
- 10+ years of CRA monitoring experience
- Proven track record managing complex clinical trials and multiple sites simultaneously
- 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
- Advanced, hands-on command of ICH-GCP, FDA, EMA, and local regulatory requirements
- Sound judgment and strong stakeholder management skills
- Comfortable operating independently and making the right call with minimal oversight
- Sharp problem-solving abilities
- Strong risk assessment instincts
- Ability to spot issues before they become obstacles
- Willingness to travel to clinical sites in Canada and in the USA, 60-70% of the time
- Bilingual (French/English) - required for Quebec sites
Desired Qualifications
- Experience mentoring or training other CRAs
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