Clinical Research Associate monitoring clinical trials for ICON, a global healthcare intelligence and clinical research organization. Ensuring protocol, ICH - GCP, and regulatory compliance across investigative sites and remote studies.
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Clinical Research Associate I, Bilingual French
Posted 1 hour ago
About the role
- Bilingual French Clinical Research Associate monitoring clinical trials for pharmaceutical and biotech sponsors. Ensuring site compliance, data integrity and audit readiness across remote and on-site visits.
Responsibilities
- Conduct and coordinate clinical monitoring and site management activities
- Perform remote and on-site visits to assess protocol and regulatory compliance
- Manage sponsor procedures and guidelines across different monitoring environments
- Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations and SOPs
- Maintain audit readiness and collaborative relationships with investigational sites
- Monitor investigator sites using risk-based monitoring, root cause analysis and corrective/preventive actions
- Ensure data accuracy through source document review, source data verification and case report form review
- Assess investigational products through inventory and records review
- Document observations in reports and letters and escalate deficiencies through resolution
- Maintain contact with sites between monitoring visits to confirm protocol adherence and issue resolution
- Participate in investigator payments, investigator meetings, site identification, site initiation, trial closeout and trial-material retrieval
- Ensure essential documents are complete and conduct on-site file reviews
- Track trial status and provide progress reports; maintain clinical trial management systems
- Facilitate communication among sites, the client company and internal project teams
- Respond to company, client and regulatory requirements, audits and inspections
- Complete expense reports and timesheets
- Support project publications, tools, process-improvement initiatives and other project work
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 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 may consist of a combination of appropriate education, training and/or directly related experience
- Basic medical/therapeutic area knowledge and understanding of medical terminology
- Working knowledge of ICH GCPs, applicable regulations and procedural documents, or ability to attain and maintain it
- Good oral and written communication skills with medical personnel
- Good interpersonal, organizational and time management skills
- 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
- 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 arrangement
- Full-time employment
- Standard Monday–Friday work schedule
- Frequent travel expenses likely covered through employer processes
- Personal protective equipment provided/required, including protective eyewear, garments and gloves
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