Clinical Research Associate I, Bilingual French

This is a fully remote position, open to applicants in Canada.

📋 Description

• Execute and coordinate clinical monitoring and site management activities.

• Carry out remote and on-site visits to evaluate compliance with protocols and regulations.

• Oversee necessary documentation along with sponsor-specific procedures and guidelines.

• Ensure that trials adhere to approved protocols, ICH-GCP guidelines, relevant regulations, and SOPs.

• Safeguard the rights and well-being of subjects while ensuring data reliability and audit preparedness.

• Foster collaborative relationships with investigational sites.

• Monitor investigator sites utilizing a risk-based monitoring strategy.

• Implement root cause analysis, critical thinking, and problem-solving techniques to identify site-process deficiencies and develop corrective or preventive actions.

• Ensure data precision through review of source documents, source data verification, and CRF review.

• Evaluate the investigational product through inventory and records assessments.

• Document findings in reports and letters, escalating any deficiencies to clinical management.

• Maintain communication with investigative sites between monitoring visits and follow up on issues until resolution.

• Execute monitoring tasks as per approved monitoring plans.

• Participate in investigator payment processes and attend investigator meetings.

• Assist in identifying qualified investigators and initiating clinical trial sites.

• Conduct trial closeout activities and retrieve trial materials.

• Ensure that essential documents are complete and conduct on-site file reviews.

• Monitor trial status and provide updates on progress.

• Maintain accurate and up-to-date study systems, including Clinical Trial Management Systems.

• Facilitate communication among investigative sites, client companies, and internal project teams.

• Address company, client, and regulatory requirements, audits, and inspections.

• Complete expense reports and timesheets.

• Assist with project publications and tools, contributing 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 equivalent 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 may be considered through a combination of appropriate education, training, and/or directly related experience.

• Basic knowledge of medical/therapeutic areas and understanding of medical terminology.

• Ability to acquire and maintain a working knowledge of ICH GCPs, applicable regulations, and procedural documents.

• Strong oral and written communication skills, including interactions with medical personnel.

• Effective interpersonal, organizational, and time-management abilities.

• Customer-focused with good listening skills, attention to detail, and the capability to identify underlying issues.

• Flexibility and adaptability to changing situations.

• Well-developed critical thinking, root-cause analysis, and problem-solving capabilities.

• Capability to manage risk-based monitoring concepts and processes.

• Ability to work independently or as part of a team.

• Proficient in Microsoft Office and open to learning new software.

• Strong English and French language skills, including grammar.

• Willingness and ability to travel frequently, generally 60–80%, including potential extended overnight stays.

• Capacity to work in office, laboratory, clinical, and/or home-office settings while utilizing required personal protective equipment.

🏝️ Benefits

• Fully remote work environment.

• Standard Monday–Friday work schedule.

• Exposure to diverse 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.