Clinical Research Associate II, Bilingual

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

📋 Description

• Execute and coordinate activities related to clinical monitoring and site management.

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

• Oversee sponsor procedures, guidelines, documentation, and monitoring environments.

• Ensure that trials adhere to approved protocols, ICH-GCP guidelines, applicable 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 risk-based monitoring, root cause analysis, critical thinking, and problem-solving techniques.

• Guarantee data accuracy through the review of source documents, source data verification, and CRF examination.

• Evaluate investigational product inventory and maintain records.

• Document observations in reports and letters, escalating deficiencies until resolution is achieved.

• Maintain communication with investigative sites between monitoring visits.

• Engage in investigator payments and share responsibility for resolving issues.

• Participate in investigator meetings and identify potential investigators.

• Initiate clinical trial sites and provide compliance recommendations.

• Conduct trial closeout activities and retrieve trial materials.

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

• Deliver trial status tracking and progress reports to the Clinical Team Manager.

• Update clinical trial management systems in accordance with study conventions.

• Facilitate communication among investigative sites, client companies, and the PPD project team.

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

• Complete administrative tasks such as expense reports and timesheets.

• Assist in project publications and tools while contributing to process-improvement initiatives.

⛳️ Requirements

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

• Approximately 1 year of experience in clinical research monitoring, or completion of the PPD Drug Development Fellowship.

• Consideration may be given to equivalency through a combination of appropriate education, training, and/or directly related experience.

• Valid driver's license where applicable.

• Demonstrated clinical monitoring skills.

• Understanding of medical/therapeutic area knowledge and medical terminology.

• Working knowledge of ICH GCPs, applicable regulations, and procedural documentation.

• Familiarity with Risk-Based Monitoring concepts and processes.

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

• Proficient oral and written communication skills, including interaction with medical personnel.

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

• Strong organizational and time management skills.

• Excellent interpersonal skills.

• Flexibility and adaptability in various situations.

• Ability to work independently or collaboratively within a team.

• Proficiency in Microsoft Office and a capacity to learn relevant software.

• Strong command of English and French language and grammar.

• Effective presentation skills.

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

• Capability to work in office, laboratory, clinical, and/or home-office settings.

• Ability to utilize 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 covered as required by site travel.