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

Clinical Research, PharmaceuticalsIndustries

Requirements

3 years of monitoring experience
French-speaking (francophone)
Based in 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 for potential investigators
Assesses site capacity to successfully manage and 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 IRB/IEC approval for study-specific documents
Conducts study initiation activities, reviews protocol, regulatory issues, study procedures with site staff, provides training at the end of FERC, and covers monitoring and close-out activities
Trains site staff on the EDC system and verifies the site's computer system
Assists in resolving issues to ensure site file audit compliance in collaboration with ISS
Ensures compliance with Good Clinical Practices, investigator integrity, and study procedures through on-site monitoring visits
Performs source documentation validation per sponsor requirements
Prepares monitoring reports and letters within IQVIA PON deadlines using approved templates
Documents accountability, stability, and storage conditions of investigational materials 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 internal eCRF review and 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 from the site
Conducts study close-out visits per the study-specific monitoring plan, including investigational product reconciliation, site study file reconciliation, data query resolution until database lock, and pending action items
Assists and participates in investigator meetings for assigned studies
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 per IQVIA and/or study timelines; DECs must stay updated with updates

Skills

Clinical Trial Monitoring

Site Initiation

Site Close-out

GCP Compliance

EDC Training

Regulatory Documentation

IRB Approval

Protocol Review

Site Evaluation

French Language

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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