[Remote] Experienced Bilingual CRA - Quebec, Canada at Thermo Fisher Scientific

Canada

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Pharmaceuticals, BiotechnologyIndustries

Requirements

Bilingual (implied for Quebec, Canada)
Experienced Clinical Research Associate (CRA)
Knowledge of protocol compliance, ICH-GCP guidelines, applicable regulations, and SOPs
Ability to apply root cause analysis (RCA), critical thinking, and problem-solving skills
Familiarity with risk-based monitoring approach
Proficiency in data review processes (SDR, SDV, CRF review)
Skills in business writing standards for reports and letters
Ability to manage procedures and guidelines from different sponsors/monitoring environments (FSO, FSP, Government)
Availability for standard Mon-Fri office schedule, including remote or on-site visits

Responsibilities

Performs and coordinates all aspects of clinical monitoring and site management
Conducts remote or on-site visits to assess protocol and regulatory compliance and manages documentation
Monitors investigator sites using risk-based approach, identifying process failures and corrective/preventive actions
Ensures data accuracy through SDR, SDV, and CRF review via on-site and remote activities
Assesses investigational products through physical inventory and records review
Documents observations in reports and letters timely using approved standards
Escalates deficiencies/issues to clinical management and follows through to resolution
Maintains regular contact with sites between visits to confirm protocol adherence, issue resolution, and timely data recording
Conducts monitoring tasks per approved monitoring plan and participates in investigator payment process
Shares responsibility with project team on issues/findings resolution and investigates follow-ups
Participates in investigator meetings and identifies potential investigators with client
Initiates clinical trial sites per procedures, ensuring compliance and making recommendations
Performs trial close out and retrieval of trial materials
Ensures essential documents are complete per ICH-GCP and regulations
Conducts on-site file reviews per project specifications
Provides trial status tracking and progress update reports to Clinical Team Manager (CTM)
Acts as site processes specialist to guarantee subject rights, well-being, data reliability, and audit readiness
Develops collaborative relationships with investigational sites

Skills

Key technologies and capabilities for this role

Clinical MonitoringSite ManagementProtocol ComplianceICH-GCPRegulatory ComplianceAudit ReadinessRemote VisitsOn-site VisitsBilingual

Questions & Answers

Common questions about this position

Is this a remote position or does it require on-site work?

The role involves both remote and on-site visits to investigator sites for monitoring, conducted in an office environment with a standard Monday-Friday schedule.

What are the key skills required for this Clinical Research Associate role?

Key skills include clinical monitoring and site management, risk-based monitoring with root cause analysis, critical thinking and problem-solving, ensuring protocol compliance with ICH-GCP and regulations, and data review through SDR, SDV, and CRF.

What is the salary or compensation for this position?

This information is not specified in the job description.

What is the company culture like at Thermo Fisher Scientific?

The culture emphasizes meaningful work with global impact, enabling customers to make the world healthier through research and life-changing therapies, while providing resources for individual career goals and fostering collaborative relationships.

What makes a strong candidate for this Experienced Bilingual CRA role?

A strong candidate has experience in clinical monitoring, excels in risk-based approaches with root cause analysis and problem-solving, ensures regulatory compliance and data accuracy, and can build collaborative site relationships while managing documentation effectively.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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