Associé de recherche clinique,Télécommande– francophone Clinical Research Associate,Remote

Position: Associé de recherche clinique, Télécommande– francophone IQVIA Clinical Research Associate, Remote - French speaking
Location: Kirkland

Job Description

To be eligible for this position, you must reside in the same country where the job is located.

· 3 years of experience in follow-up;

· BASIC FUNCTIONS:

Participates in the preparation and execution of Phase I to IV clinical trials. Oversees the progress of clinical investigations by conducting interim site assessment, initiation, and closure visits. Monitors clinical trials in accordance with clinical best practices and procedures established by IQVIA and its sponsors. Works closely with the Clinical Trial Director (CTD) and/or the lead CRA to ensure that follow-up activities are conducted in accordance with study requirements.

The lead RCAF may also act as the lead CRA.

ESSENTIAL DUTIES, DUTIES AND RESPONSIBILITIES OF THE POSITION:

· Participates in the investigator recruitment process. Conducts on-site evaluation visits of potential investigators. Evaluates the site's ability to successfully manage and conduct the clinical study.

· Collaborates with ISS to coordinate activities with the site in preparation for the launch of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with the ISS and site staff to obtain regulatory approval (IRB/IEC) of study-specific documents.

· Conducts study initiation activities, reviews protocol, regulatory issues, study procedures with site staff, and provides training at the end of FERC; monitoring activities and study closure activities.

· Trains site staff on the EDC system and verifies the site's computer system.

· Helps resolve any issues to ensure compliance with site file audits in collaboration with the ISS.

· Ensures adherence to good clinical practices, investigator integrity, and adherence to study procedures through on-site monitoring visits. Performs validation of source documentation as per sponsor's requirements. Prepares monitoring reports and letters according to the timelines defined in IQVIA SOPs using templates and reports approved by IQVIA or the Sponsor.

· Documents the responsibility, stability, and storage conditions of clinical trial material as required by the sponsor. Conducts inventory of investigative products. Ensures the return of unused materials to the designated location or verifies destruction, if applicable.

· Examines the quality and integrity of clinical data through (1) an internal review of the FIU's electronic data and (2) an on-site source verification. Works with sites to resolve data queries.

· May review protocols, FERCs, study manuals, and other related documents, as requested by the clinical trial authority and/or the lead CRA.

· Serves as the primary contact between IQVIA and the investigator; coordinates all correspondence;
Ensures timely transmission of clinical data with study site and technical reports as requested.

· Conducts study closure visits in accordance with the study-specific clinical follow-up plan, including reconciliation and disposition of final investigation products, reconciliation of site study files, resolution of data queries up to database locking, and resolution of outstanding action items.

· Attends and participates in investigators' meetings for assigned studies.

· Is allowed to request site audits due to data integrity issues.

· Attends study, business, department, and outside related meetings as required.

· Ensures that internal and study-related trainings are completed in accordance with IQVIA and/or study's schedules; DECs should always be updated with relevant site updates/contacts.

· Ensures that study deliverables are completed according to IQVIA Biotech and study schedules.

· Conducts field assessment visits and field training of RCAF I, II and other core RCAs.

· Serves as a mentor for CRA assistants and those who are new to the business and/or study.

Performs other duties, as requested.

You will be required to support, liaise with and/or work with IQVIA customers and/or suppliers across Canada and around the world therefore, a functional knowledge of English, both written and spoken, is necessary to perform the duties of this position.

ESSENTIAL DUTIES, DUTIES AND RESPONSIBILITIES OF THE SENIOR CRA POSITION:

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Associé de recherche clinique, Télécommande– francophone Clinical Research Associate, Remote - French speaking