Experienced Clinical Research Associate (CRA II/Sr CRA)
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an Experienced Clinical Research Associate (CRA II/Sr CRA) based in Canada.
This role offers the opportunity to contribute directly to the successful execution of clinical trials across diverse therapeutic and monitoring environments.
You’ll oversee clinical site activities, ensuring trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and established procedures.
The position combines remote and on-site monitoring with meaningful collaboration across investigators, project teams, sponsors, and regulatory stakeholders.
You’ll use risk-based monitoring, critical thinking, and root cause analysis to identify issues and drive appropriate corrective and preventive actions.
Your work will help protect participant safety, maintain data integrity, and keep studies audit-ready throughout their lifecycle.
As part of a global clinical research environment, you’ll have opportunities to contribute to process improvements, project initiatives, and effective site relationships.
This is a fully remote position in Canada with significant travel to clinical sites, generally around 60-80% depending on project requirements.
Accountabilities
Conduct remote and on-site monitoring visits using risk-based monitoring principles, including source data review, source data verification, CRF review, and investigational product accountability.
Assess investigator sites for protocol, regulatory, ICH-GCP, and procedural compliance, identifying risks, deficiencies, and opportunities for improvement.
Apply critical thinking and root cause analysis to investigate site process issues and recommend appropriate corrective and preventive actions.
Document monitoring findings, observations, follow-up actions, and site communications accurately and within required timelines.
Escalate significant deficiencies and unresolved issues to clinical management and follow findings through to resolution.
Maintain regular communication with investigative sites between monitoring visits to confirm protocol adherence, issue resolution, and timely data entry.
Conduct site initiation, monitoring, and close-out activities in accordance with approved monitoring plans and applicable procedures.
Support investigator identification and selection in collaboration with relevant stakeholders, assessing site suitability and investigator qualifications.
Participate in investigator meetings and support the successful initiation and management of clinical trial sites.
Ensure essential documents and site files are complete, accurate, and maintained in accordance with ICH-GCP and applicable regulations.
Track trial status and provide progress updates to the Clinical Team Manager and broader project team.
Maintain clinical trial management systems and other study platforms according to established conventions.
Facilitate effective communication between investigative sites, sponsors, project teams, and other stakeholders through written, verbal, and electronic channels.
Respond to sponsor, regulatory, audit, and inspection requirements as needed.
Support investigator payment processes and complete administrative responsibilities such as expense reports and timesheets accurately and on time.
Contribute to project publications, tools, process improvements, and other clinical research initiatives.
Share insights, recommendations, and best practices with project team members to strengthen study execution.
Bachelor’s degree in a life sciences-related field, Registered Nursing certification, or an equivalent relevant academic or vocational qualification.
Previous experience providing the knowledge and capabilities required for clinical research monitoring, typically including at least 1 year of clinical research monitor experience, or successful completion of a relevant drug development fellowship.
Valid driver’s license where applicable.
Demonstrated clinical monitoring expertise and understanding of clinical research processes.
Working knowledge of medical terminology and relevant therapeutic areas.
Strong and current understanding of ICH-GCP requirements, applicable regulations, and clinical research procedures.
Ability to apply risk-based monitoring concepts and processes effectively.
Strong critical-thinking, investigative, root-cause analysis, and problem-solving skills.
Excellent written and verbal communication skills, including the ability to communicate effectively with medical professionals and clinical research stakeholders.
Strong customer and site focus, with active listening skills, attention to detail, and the ability to identify underlying issues.
Good organizational and time-management skills, with the ability to manage multiple priorities independently.
Effective interpersonal and relationship-building skills.
Ability to remain flexible and adaptable across different projects, sites, and monitoring environments.
Comfortable working both independently and collaboratively as part of a multidisciplinary project team.
Good computer skills, including proficiency with Microsoft Office and the ability to learn relevant clinical research systems.
Strong English and French language and grammar skills, both written and spoken.
Good presentation and stakeholder communication skills.
Willingness and ability to travel frequently to clinical sites, generally approximately 60-80%, including potential overnight stays.
Ability to work in environments where exposure to biological fluids, infectious organisms, personal protective equipment, and occasional fluctuating temperatures may occur.
Fully remote position based in Canada.
Full-time employment with a standard Monday-Friday schedule.
Opportunity to contribute to clinical trials supporting pharmaceutical and biotechnology research.
Exposure to a broad range of sponsors, therapeutic areas, clinical sites, and monitoring environments.
Opportunities to collaborate with international clinical research and project teams.
Professional development through hands-on clinical research experience and participation in project initiatives.
Opportunity to contribute to process improvement and clinical research best practices.
Work that directly supports participant safety, data quality, regulatory compliance, and the successful delivery of clinical studies.
Reasonable accommodations available for candidates with disabilities throughout the recruitment and employment process.
Frequent travel to clinical sites, generally 60-80%, with potential extended overnight stays depending on project requirements.