Associé de recherche clinique, – francophone (Canada), IQVIA Clinical Research Associate - 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

Pharmaceuticals, Clinical ResearchIndustries

Requirements

3 years of experience in monitoring
French-speaking (francophone)

Responsibilities

Participates in the preparation and execution of phase I to IV clinical trials
Supervises the progress of clinical investigations by conducting site evaluation, initiation, and close-out visits
Ensures clinical trials are followed in accordance with best clinical practices and procedures established by IQVIA and its sponsors
Works closely with the Clinical Trial Director (DEC) and/or Lead CRA to ensure monitoring activities are conducted in accordance with study requirements; may also act as Lead CRA
Participates in the investigator recruitment process and conducts on-site evaluation visits of potential investigators
Evaluates the site's capacity to manage and successfully conduct the clinical study
Collaborates with the ISS department to coordinate site activities in preparation 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
Conducts study initiation activities, reviews protocol, regulatory questions, study procedures with site staff, provides training at the end of FERC; conducts monitoring and study close-out activities
Trains site staff on the EDC system and verifies the site's computer system
Assists in resolving issues to ensure compliance with site file audits in collaboration with ISS
Ensures compliance with Good Clinical Practices, investigator integrity, and study procedures through on-site monitoring visits
Performs source documentation validation according to sponsor requirements
Prepares monitoring reports and letters according to timelines defined in IQVIA SOPs using approved IQVIA/sponsor templates
Documents accountability, stability, and storage conditions of clinical trial material as required by the sponsor
Performs investigational product inventory 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 other related documents at the request of the trial manager and/or Lead CRA
Serves as the primary contact between IQVIA and the investigator; coordinates all correspondence; ensures timely transmission of clinical data and technical reports
Conducts study close-out visits according to the study-specific clinical monitoring plan, including reconciliation and disposition of final 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, department, and external meetings as applicable
Ensures internal and study-related trainings are completed according to IQVIA and/or study timelines; DEC must always be up-to-date with updates

Skills

Key technologies and capabilities for this role

GCPClinical MonitoringSite InitiationSite CloseoutEDCIRBIECRegulatory ComplianceProtocol ReviewClinical Trials

Questions & Answers

Common questions about this position

What salary is offered for this Clinical Research Associate position?

This information is not specified in the job description.

Is this Clinical Research Associate role remote or office-based?

This information is not specified in the job description.

What experience is required for this Clinical Research Associate position?

The role requires 3 years of experience in monitoring.

What are the main responsibilities of this Clinical Research Associate role?

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

What makes a strong candidate for this French-speaking Clinical Research Associate role at IQVIA?

Candidates with 3 years of monitoring experience who can handle site evaluations, regulatory documentation, study launches, monitoring visits, data verification, and collaboration with sites and sponsors will stand out.

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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