Senior Clinical Research Associate overseeing clinical trial sites for Novo Nordisk, a pharmaceutical company developing treatments for chronic diseases. Ensuring compliant monitoring, patient safety, data integrity and timely study execution.
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Clinical Research Associate I, Bilingual French
Posted yesterday
About the role
- Clinical Research Associate monitoring clinical trials for pharmaceutical and biotech clients. Ensuring site compliance, data accuracy, essential documentation, and audit readiness across Alberta.
Responsibilities
- Perform and coordinate clinical monitoring and site-management activities
- Conduct remote and on-site visits to assess protocol and regulatory compliance
- Manage required documentation and sponsor-specific procedures and guidelines
- Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs
- Protect subjects' rights and well-being and ensure data reliability and audit readiness
- Develop collaborative relationships with investigational sites
- Monitor investigator sites using a risk-based monitoring approach
- Apply root cause analysis, critical thinking, and problem-solving to identify site-process failures and corrective/preventive actions
- Ensure data accuracy through source document review, source data verification, and CRF review
- Assess investigational product through inventory and records review
- Document observations in reports and letters and escalate deficiencies to clinical management
- Maintain contact with investigative sites between monitoring visits and follow issues through resolution
- Conduct monitoring tasks according to approved monitoring plans
- Participate in investigator payment processes and investigator meetings
- Help identify qualified investigators and initiate clinical trial sites
- Perform trial closeout and retrieve trial materials
- Ensure essential documents are complete and conduct on-site file reviews
- Track trial status and provide progress updates
- Maintain accurate and current study systems, including Clinical Trial Management Systems
- Facilitate communication among investigative sites, client companies, and internal project teams
- Respond to company, client, and regulatory requirements, audits, and inspections
- Complete expense reports and timesheets
- Assist with project publications and tools and contribute to process-improvement initiatives
Requirements
- Bachelor's degree in a life sciences related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification
- Minimal clinical monitoring experience comparable to 2 years (24 months) in a clinical environment involving clinical trials, medical terminology, medical research, clinical research, health care, or a health sciences field with formal training in medical terminology and anatomy
- Valid driver's license where applicable
- Equivalency through a combination of appropriate education, training, and/or directly related experience may be considered
- Basic medical/therapeutic area knowledge and understanding of medical terminology
- Ability to attain and maintain working knowledge of ICH GCPs, applicable regulations, and procedural documents
- Good oral and written communication skills, including communication with medical personnel
- Good interpersonal, organizational, and time-management skills
- Customer-focus, listening skills, attention to detail, and ability to identify underlying issues
- Flexibility and adaptability
- Well-developed critical-thinking, root-cause-analysis, and problem-solving skills
- Ability to manage risk-based monitoring concepts and processes
- Ability to work independently or as part of a team
- Solid knowledge of Microsoft Office and ability to learn appropriate software
- Good English and French language and grammar skills
- Willingness and ability to travel frequently, generally 60–80%, including possible extended overnight stays
- Ability to work in office, laboratory, clinical, and/or home-office environments and use required personal protective equipment
Benefits
- Fully remote work mode
- Standard Monday–Friday work schedule
- Exposure to varied clinical research projects and monitoring environments
- Professional collaboration with global pharmaceutical, biotech, client, and internal project teams
- Opportunity to contribute to project publications, tools, and process-improvement initiatives
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