Clinical Research Associate

1 month ago

Kirkland, Quebec, Canada IQVIA Full time
Job Description

As a Clinical Research Associate at IQVIA, you will play a critical role in the preparation and execution of Phase I to IV clinical trials. Your responsibilities will include overseeing the progress of clinical investigations, conducting interim site assessment, initiation, and closure visits, and monitoring clinical trials in accordance with clinical best practices and procedures established by IQVIA and its sponsors.

Key Responsibilities
  • Participate in the investigator recruitment process, conducting on-site evaluation visits of potential investigators and evaluating the site's ability to successfully manage and conduct the clinical study.
  • Collaborate with ISS to coordinate activities with the site in preparation for the launch of the study, obtaining regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials.
  • Conduct study initiation activities, reviewing protocol, regulatory issues, study procedures with site staff, and providing training at the end of FERC; monitoring activities and study closure activities.
  • Train site staff on the EDC system and verify the site's computer system.
  • Help resolve any issues to ensure compliance with site file audits in collaboration with the ISS.
  • Ensure adherence to good clinical practices, investigator integrity, and adherence to study procedures through on-site monitoring visits, performing validation of source documentation as per sponsor's requirements, and preparing monitoring reports and letters according to the timelines defined in IQVIA SOPs using templates and reports approved by IQVIA or the Sponsor.
  • Document the responsibility, stability, and storage conditions of clinical trial material as required by the sponsor, conducting inventory of investigative products, and ensuring the return of unused materials to the designated location or verifying destruction, if applicable.
  • Examine the quality and integrity of clinical data through an internal review of the FIU's electronic data and an on-site source verification, working 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.
  • Serve as the primary contact between IQVIA and the investigator, coordinating all correspondence, and ensuring timely transmission of clinical data with study site and technical reports as requested.
  • Conduct 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.
  • Attend and participate in investigators' meetings for assigned studies.
  • Is allowed to request site audits due to data integrity issues.
  • Attend study, business, department, and outside related meetings as required.
  • Ensure that internal and study-related trainings are completed in accordance with IQVIA and/or study's schedules; CTAs should always be updated with relevant site updates/contacts.
  • Ensure that study deliverables are completed according to IQVIA and study schedules.
  • May conduct field assessment visits and field training of RCAF I, II, and senior RCAF.
  • Serve as a mentor for CRA assistants and those who are new to the business and/or study.
  • Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of a potential CRA.
  • Reviews and approves CRA travel expenses and timesheets.
  • Perform other duties, as required.

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