Associé de recherche clinique, Télécommande– francophone (Canada), IQVIA Clinical Research Associate, Remote - French speaking (Canada), IQVIA at IQVIA

Montreal, Quebec, Canada

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, PharmaceuticalsIndustries

Requirements

3 years of monitoring experience
French-speaking (francophone), based in Canada
Ability to work remotely (Télécommande– francophone (Canada))

Responsibilities

Participates in the preparation and execution of phase I to IV clinical trials
Supervises the progress of clinical investigations through evaluation, initiation, and close-out visits at sites
Ensures clinical trials are followed according to best clinical practices and procedures established by IQVIA and sponsors
Works closely with the Clinical Trial Director (DEC) and/or Lead CRA to ensure monitoring activities meet study requirements; may act as Lead CRA
Participates in investigator recruitment and conducts on-site evaluation visits of potential investigators
Evaluates site capacity to manage and conduct the clinical study successfully
Collaborates with the ISS service to coordinate site activities for study initiation
Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials
Works with ISS and site staff to obtain regulatory approval (IRB/IEC) for study-specific documents
Performs study initiation activities, reviews protocol, regulatory issues, study procedures with site staff, provides training at the end of FERC; conducts monitoring and close-out activities
Trains site staff on the EDC system and verifies the site's computer system
Helps resolve issues to ensure site file audit compliance in collaboration with ISS
Ensures compliance with Good Clinical Practices (GCP), investigator integrity, and study procedures through on-site monitoring visits
Performs source data validation according to sponsor requirements
Prepares monitoring reports and letters within IQVIA PON timelines using approved templates
Documents accountability, stability, and storage conditions of investigational materials as required by the sponsor
Performs inventory of investigational products and ensures return of unused materials or verifies destruction
Reviews quality and integrity of clinical data through (1) internal review of electronic CRF data and (2) on-site source verification
Collaborates with sites to resolve data queries
May review protocols, FERC, study manuals, and related documents at the request of the trial manager and/or Lead CRA
Serves as primary contact between IQVIA and the investigator; coordinates all correspondence; ensures timely transmission of clinical data and technical reports
Performs study close-out visits per the study-specific monitoring plan, including reconciliation and disposition of investigational products, site study file reconciliation, resolution of data queries until database lock, and resolution of outstanding action items
Assists and participates in investigator meetings for assigned studies
Is authorized to request site audits due to data integrity issues
Attends study-related, company, departmental, and external meetings as applicable
Ensures internal and study-related trainings are completed per IQVIA and/or study timelines; DEC must stay updated with relevant updates/contacts

Skills

Key technologies and capabilities for this role

Clinical MonitoringGCPEDC SystemsSite VisitsIRB/IECProtocol ReviewRegulatory ComplianceSite InitiationSite CloseoutClinical Trials

Questions & Answers

Common questions about this position

Is this a remote position?

Yes, this is a remote position for a French-speaking Clinical Research Associate in Canada.

What experience is required for this role?

The role requires 3 years of experience in monitoring.

What are the main responsibilities of this position?

Responsibilities include participating in clinical trials from phase I to IV, supervising investigations through site visits, ensuring compliance with best clinical practices, and collaborating closely with the Clinical Trial Director and/or Lead CRA.

What is the employment type for this job?

This is a full-time position.

What makes a strong candidate for this CRA role?

A strong candidate has 3+ years of monitoring experience, skills in site evaluation and recruitment, regulatory documentation handling, on-site monitoring visits, data verification, and the ability to collaborate with sites and IQVIA teams.

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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