Bilingual CRA II

Thermo Fisher Scientific

Clinical Research Associate monitoring clinical trials for compliance with protocols at Thermo Fisher Scientific. Conducting remote and onsite site management processes for investigational studies.

Posted 7/25/2026full-timeRemote • 🇨🇦 CanadaJuniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial monitoring, ensuring compliance with ICH-GCP and regulatory standards while effectively communicating with investigative sites and project teams. Proficient in data accuracy verification and risk-based monitoring approaches, including root cause analysis and problem-solving.

Highest-signal resume keywords

Clinical Trial MonitoringICH-GCP ComplianceRoot Cause AnalysisData Accuracy VerificationEffective Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Risk-Based MonitoringData ReviewSite Process AssessmentTrial Close OutMonitoring Plan Execution

Soft Skills

Critical ThinkingProblem-SolvingTeam CollaborationTime Management

Tools & Technologies

Clinical Trial Management SystemElectronic Communication Tools

Certifications & Qualifications

Bachelor's Degree in Life SciencesRegistered Nursing Certification

Industry Keywords

Clinical ResearchInvestigational Product AssessmentRegulatory ComplianceSite QualificationProject Management

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
Assesses investigational product through physical inventory and records review.
Documents observations in reports and letters in a timely manner using approved business writing standards.
Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.
Conducts monitoring tasks in accordance with the approved monitoring plan.
Participates in the investigator payment process.
Ensures shared responsibility with other project team members on issues/findings resolution.
Investigates and follows-up on findings as applicable.
Participates in investigator meetings as necessary.
Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted.
Performs trial close out and retrieval of trial materials.
Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations.
Conducts on-site file reviews as per project specifications.
Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).
Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
Responds to company, client and applicable regulatory requirements/audits/inspections.
Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
Contributes to other project work and initiatives for process improvement, as required.

Requirements

What you’ll need

Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship.
Valid driver's license where applicable. In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Benefits

Comp & perks

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