FSP Clinical Research Associate I - Bilingual French QC Canada

Thermo Fisher Scientific

About The Position

As a Clinical Research Associate I, you will perform and coordinate clinical monitoring and site management activities. You will conduct remote and on-site visits to assess protocol and regulatory compliance, manage required documentation, and apply sponsor procedures and guidelines across different monitoring environments. You will help ensure trials are conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and standard operating procedures, protecting subjects’ rights and well-being and supporting reliable data. The role also involves maintaining audit readiness and building collaborative relationships with investigational sites. The position includes monitoring investigator sites using a risk-based approach, reviewing data and investigational products, documenting and escalating issues, and following findings through resolution. You will support site initiation and closeout, essential-document management, trial tracking, study-system upkeep, investigator payments and meetings, and communication among sites, clients, and internal teams. You may also contribute to project materials and process-improvement initiatives. Work is performed in an office, laboratory, clinical, or home-office environment. Frequent driving to site locations and travel—generally 60–80%, potentially more for some individuals—are expected and may include extended overnight stays. The role may involve exposure to biological fluids and infectious organisms, electrical office equipment, and, rarely, fluctuating or extreme temperatures. Personal protective equipment such as protective eyewear, garments, and gloves is required.

Requirements

Bachelor’s degree in a life sciences-related field, Registered Nursing certification, or equivalent relevant formal academic or vocational qualification.
Minimal clinical monitoring experience providing the knowledge and skills to perform the role, comparable to 2 years, in a clinical environment involving clinical trials, medical terminology, medical research, clinical research, or health care; alternatively, experience in a health sciences field with formal training in medical terminology and anatomy may be considered.
Valid driver’s license where applicable.
Basic medical or therapeutic-area knowledge and understanding of medical terminology.
Ability to attain and maintain working knowledge of ICH-GCP, applicable regulations, and procedural documents.
Good oral and written communication skills, including the ability to communicate effectively with medical personnel.
Good interpersonal skills.
Ability to maintain customer focus through listening, attention to detail, and identifying customers’ underlying issues.
Good organizational and time-management skills.
Ability to remain flexible and adaptable in a wide range of scenarios.
Well-developed critical-thinking skills, including a critical mindset, in-depth investigation for root-cause analysis, and problem solving.
Ability to manage risk-based monitoring concepts and processes.
Ability to work independently or as part of a team, as required.
Good computer skills, including solid knowledge of Microsoft Office and ability to learn appropriate software.
Good English and French language and grammar skills.

Responsibilities

Monitor investigator sites using a risk-based monitoring approach; identify site-process failures and recommend corrective and preventive actions.
Ensure data accuracy through source document review, source data verification, and case report form review, as applicable, during on-site and remote monitoring.
Assess investigational products through physical inventory and records review.
Document observations in reports and letters promptly and in accordance with approved business-writing standards.
Escalate deficiencies and issues to clinical management and follow them through resolution.
Maintain contact with investigative sites between monitoring visits as needed to confirm protocol compliance, resolution of previously identified issues, and timely data recording.
Conduct monitoring tasks according to the approved monitoring plan.
Participate in the investigator payment process and share responsibility with project team members for resolving issues and findings.
Investigate and follow up on findings, as applicable.
Participate in investigator meetings as necessary.
Help identify potential investigators with the client company when needed.
Initiate clinical trial sites according to applicable procedures and recommend actions to support compliance with protocol, regulatory, and ICH-GCP obligations.
Perform trial closeout and retrieve trial materials.
Ensure required essential documents are complete and in place according to ICH-GCP and applicable regulations.
Conduct on-site file reviews according to project specifications.
Provide trial-status tracking and progress updates to the team as required.
Ensure study systems, such as the Clinical Trial Management System, are complete, accurate, and updated according to agreed conventions.
Facilitate written, oral, and electronic communication among investigative sites, the client company, and internal project teams.
Respond to company, client, and applicable regulatory requirements, audits, and inspections.
Complete administrative tasks, including expense reports and timesheets, promptly.
Assist with project publications and tools, share ideas with team members, and contribute to other project work and process-improvement initiatives as required.