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 experience in tracking

Responsibilities

Participate in the investigator recruitment process
Conduct on-site investigator evaluation visits
Assess the site's ability to manage and successfully conduct the clinical study
Collaborate with the ISS (Intelligence, Surveillance & Solutions) team to coordinate activities with the site in preparation for study launch
Obtain regulatory documentation for successful clinical trial implementation, monitoring, and evaluation
Work with ISS and site personnel to obtain regulatory approval (IRB/IEC) of study-specific documents
Perform study launch activities, reviewing with site personnel the study protocol, regulatory questions, study procedures, and providing end-of-FERC training; monitoring and study close-out activities
Train site personnel on the EDC (Electronic Data Capture) system and verify the site's IT system
Assist in resolving issues to ensure compliance with site file audit requirements in collaboration with ISS
Ensure adherence to good clinical practices, investigator integrity, and study procedures through on-site control visits
Perform source data verification according to sponsor requirements
Prepare monitoring reports and letters within the deadlines defined in IQVIA/sponsor PONs (Project Operations Notices) using approved templates and reports
Document the responsibility, stability, and storage conditions of clinical trial materials as required by the sponsor
Perform inventory of investigational products
Ensure the return of unused materials to the designated location or verify destruction, as applicable
Examine the quality and integrity of clinical data through (1) internal electronic CRF data review and (2) source data verification on-site
Collaborate with sites to resolve data queries
May review protocols, FERCs, study manuals, and other related documents, at the request of the Clinical Trial Manager and/or Principal ARC

Skills

Clinical Trial Monitoring

GCP

EDC

IRB

IEC

Source Data Verification

Regulatory Documentation

Site Evaluation

Study Launch

Monitoring Reports

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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