Clinical Research Associate I, Bilingual French

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

📋 Description

• Oversee and coordinate clinical monitoring and management activities at sites.

• Conduct both remote and on-site visits to evaluate compliance with protocols and regulations.

• Administer sponsor procedures and guidelines across various monitoring settings.

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

• Maintain audit readiness and foster collaborative relationships with investigational sites.

• Monitor investigator sites employing risk-based monitoring, root cause analysis, and corrective/preventive actions.

• Guarantee data accuracy through the review of source documents, source data verification, and case report form evaluation.

• Evaluate investigational products through inventory and record assessments.

• Document findings in reports and letters, escalating any deficiencies until resolution.

• Keep in touch with sites between monitoring visits to confirm adherence to protocols and resolve issues.

• Assist in investigator payments, meetings, site identification, site initiation, trial closeout, and retrieval of trial materials.

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

• Monitor trial status and generate progress reports; maintain clinical trial management systems.

• Facilitate communication among sites, the client organization, and internal project teams.

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

• Complete expense reports and timesheets.

• Support project publications, tools, process improvement initiatives, and other project-related work.

⛳️ Requirements

• Bachelor's degree in a life sciences-related field, Registered Nursing certification, or a similar relevant academic/vocational qualification.

• Minimum clinical monitoring experience equivalent to 2 years (24 months) in clinical trials, medical terminology, medical research, clinical research, healthcare, or a health sciences field, with formal training in medical terminology and anatomy.

• Valid driver's license where applicable.

• Equivalency may include a combination of suitable education, training, and/or directly related experience.

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

• Proficient understanding of ICH GCPs, applicable regulations, and procedural documents, or the capability to acquire and maintain such knowledge.

• Strong oral and written communication skills with medical professionals.

• Excellent interpersonal, organizational, and time management abilities.

• Critical thinking, root cause analysis, and problem-solving capabilities.

• Proficient in managing Risk Based Monitoring concepts and processes.

• Capability to work independently or collaboratively within a team.

• Solid proficiency in Microsoft Office and a willingness to learn necessary software.

• Good command of English and French language and grammar skills.

• Willingness to travel frequently, typically 60–80%, which may include extended overnight stays.

• Ability to work in office, laboratory, clinical, and/or home office environments while using required personal protective equipment.

🏝️ Benefits

• Fully remote work arrangement.

• Full-time employment.

• Standard Monday–Friday work schedule.

• Frequent travel expenses typically covered through employer processes.

• Personal protective equipment provided/required, including protective eyewear, garments, and gloves.