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Clinical Research Associate

2 months ago

Kirkland, Quebec, Canada IQVIA Full time
About the Role

We are seeking a highly skilled and experienced Clinical Research Associate to join our team at IQVIA. As a Clinical Research Associate, you will be responsible for conducting clinical trials and ensuring the quality and integrity of clinical data.

Key Responsibilities
  • Participate in the investigator recruitment process and conduct on-site evaluation visits to assess the site's ability to manage and conduct clinical studies.
  • Collaborate with the Investigator Site Support (ISS) team to coordinate activities with the site in preparation for the initiation of the study.
  • Conduct study launch activities, review protocol, regulatory issues, and study procedures with site staff, and provide training at the end of the eCRF.
  • Monitor clinical trials in accordance with clinical best practices and procedures established by IQVIA and its sponsors.
  • Ensure adherence to good clinical practices, investigator integrity, and adherence to study procedures through on-site monitoring visits.
  • Perform validation of source documentation as per sponsor's requirements and prepare monitoring reports and letters according to the timelines defined in IQVIA SOPs.
  • Document the responsibility, stability, and storage conditions of clinical trial material as required by the sponsor.
  • Conduct inventory of investigative products and ensure the return of unused materials to the designated location or verify destruction, if applicable.
  • Examine the quality and integrity of clinical data through an internal review of the FRC's electronic data and an on-site source verification.
  • Work with sites to resolve data queries and may review draft protocols, FERCs, follow-up reports, and letters, study manuals, and others, prepare study-related documents and templates, as requested by the CTA and/or ED.
  • May serve as the primary contact between IQVIA and the investigator, coordinate correspondence, and ensure timely transmission of clinical data with study site and technical reports as requested.
  • Assist the DEC and/or DE in reviewing project budgets, tracking costs, potential overruns, and proposing/implementing cost-effective solutions.
  • Assist study management in identifying and generating scope changes.
  • Conduct study closure visits in accordance with the study-specific clinical follow-up plan, including reconciliation and disposition of the final investigational product, reconciliation of study files from the site, resolution of data queries up to database locking, and resolution of outstanding action items.
  • 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; CTAs should always be updated with relevant site updates/contacts.
  • Ensures 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.
  • Serves as a mentor for CRA assistants and those who are new to the business and/or study.
  • Participates 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.
Requirements
  • BS/BA/BSc (or equivalent) in one of the life sciences or healthcare fields (Ph.Aut., RN, and other) and a minimum of four (4) years of experience in site monitoring/management is required; or an equivalent combination of education, training, and experience.
  • Previous experience in a clinical research organization (CRO) preferred.
  • Previous project team leadership experience preferred.
  • Working knowledge of budget management preferred.
  • Must be able to travel domestically and internationally approximately 65% to 85%.
  • Valid driver's license.
  • Computer skills, including proficiency in Microsoft Word, Excel, and PowerPoint, and the use of a laptop.