• Job Description

  Req#: R1407468

  IQVIA Biotech is seeking a Senior Clinical Research Associate 3 with experience working in oncology located in the U.S. (field based):

  ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

  • Participates in the investigator recruitment process. Performs site evaluation visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.

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

  • Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.
  • Trains site staff on the EDC system and verifies site computer system.
  • Assists in resolving any issues to ensure compliance with site file audits in conjunction with ISS.
  • Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports.
  • Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required.
  • Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Works with sites to resolve data queries.
  • May review protocols, eCRFs, study manuals and other related documents, as requested by the Clinical Trial Manager and/or Lead CRA.
  • Serves as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.
  • Performs study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.
  • Assists with, and attends, Investigator Meetings for assigned studies.
  • Authorized to request site audits due to data integrity concerns.
  • Attends study-related, company, departmental, and external meetings, as required.
  • Serves as mentor for junior CRAs and those new to the company and/or study.

  MINIMUM RECRUITMENT STANDARDS:

  • BS/BA/BSc (or equivalent) in one of the life sciences or health care background (RPh, RN, etc) and a minimum of four (4) years of monitoring/site management experience is required; or equivalent combination of education, training and experience.
  • Prior Clinical Research Organization (CRO) experience preferred.
  • Must be able to travel domestically and internationally approximately 65%-85%.
  • Valid driver’s license

  #iqviabiotechCRA

  IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

  We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

  IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

  The potential base pay range for this role, when annualized, is $116,312.00 - $174,468.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

• About the company

  IMS Health and Quintiles are now IQVIA. We are committed to providing solutions that enable healthcare companies to innovate with confidence, maximize opportunities and, ultimately, drive healthcare forward. We do this via breakthroughs in insights, t...

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