Clinical Research Associate II, Bilingual
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Job Description
Clinical Research Associate monitoring pharmaceutical trials for protocol compliance and data integrity. Conducting remote and on-site site visits across Canadian investigational sites.
Responsibilities:
- Perform and coordinate clinical monitoring and site management activities
- Conduct remote and on-site visits to assess protocol and regulatory compliance
- Manage sponsor procedures, guidelines, documentation, and monitoring environments
- Ensure trials comply with approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs
- Protect subjects' rights and well-being and ensure data reliability and audit readiness
- Build collaborative relationships with investigational sites
- Monitor investigator sites using risk-based monitoring, root cause analysis, critical thinking, and problem-solving
- Ensure data accuracy through source document review, source data verification, and CRF review
- Assess investigational product inventory and records
- Document observations in reports and letters and escalate deficiencies through resolution
- Maintain contact with investigative sites between monitoring visits
- Participate in investigator payments and share responsibility for issue resolution
- Participate in investigator meetings and identify potential investigators
- Initiate clinical trial sites and make compliance recommendations
- Perform trial closeout and retrieve trial materials
- Ensure essential documents are complete and conduct on-site file reviews
- Provide trial status tracking and progress reports to the Clinical Team Manager
- Update clinical trial management systems according to study conventions
- Facilitate communication among investigative sites, client companies, and the PPD project team
- Respond to company, client, and regulatory requirements, audits, and inspections
- Complete administrative tasks such as 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
- Approximately 1 year of experience as a clinical research monitor, or completion of the PPD Drug Development Fellowship
- Equivalency through a combination of appropriate education, training, and/or directly related experience may be considered
- Valid driver's license where applicable
- Proven clinical monitoring skills
- Understanding of medical/therapeutic area knowledge and medical terminology
- Working knowledge of ICH GCPs, applicable regulations, and procedural documents
- Risk-Based Monitoring concepts and processes
- Critical thinking, root cause analysis, and problem-solving skills
- Oral and written communication skills, including communication with medical personnel
- Customer focus, listening skills, attention to detail, and ability to identify underlying issues
- Organizational and time management skills
- Interpersonal skills
- Flexibility and adaptability
- Ability to work independently or as part of a team
- Microsoft Office proficiency and ability to learn appropriate software
- Good English and French language and grammar skills
- Presentation 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
- Ability to use required personal protective equipment and work around biological fluids and potentially infectious organisms
Benefits:
- Fully Remote work arrangement
- Full-time employment
- Standard Monday–Friday work schedule
- Frequent travel expenses implied by required site travel
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