Senior Clinical Research Associate

hace 7 días


Buenos Aires, Argentina IQVIA A tiempo completo
Job Title: Senior Clinical Research Associate

We are seeking a highly skilled and experienced Senior Clinical Research Associate to join our team in Argentina. As a Senior Clinical Research Associate, you will be responsible for overseeing the progress of clinical investigations, conducting site evaluation and initiation visits, and monitoring clinical trials in accordance with Good Clinical Practices and procedures set forth by IQVIA Biotech and sponsors.

Key Responsibilities:
  • Participate in the preparation and execution of Phase I-IV clinical trials
  • Oversee the progress of clinical investigations by conducting site evaluation, initiation, and interim close-out visits to sites
  • Monitor clinical trials in accordance with Good Clinical Practices and procedures set forth by IQVIA Biotech and sponsors
  • Work closely with the Clinical Trial Manager (CTM) and/or Lead CRA to ensure all monitoring activities are conducted according to study requirements
  • Perform study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF
  • Monitor and report on the progress of clinical trials, including identifying and resolving any issues that may arise
  • Collaborate with the ISS department to coordinate activities with the site in preparation for the initiation of the study
  • Obtain regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials
  • Work with ISS and site staff to obtain regulatory (IRB/IEC) approval of study-specific documents
  • Perform 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
  • Assist with, and attend, 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
  • Ensure internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts
  • Ensure all study deliverables are completed per IQVIA Biotech and study timelines
Requirements:
  • BS/BA/BSc (or equivalent) in one of the life sciences or healthcare 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
  • Prior project team leadership experience preferred
  • Working knowledge of budget management preferred
  • Must be able to travel domestically and internationally approximately 65%-85%
  • Valid driver's license
  • Computer skills including proficiency in use of Microsoft Word, Excel, and PowerPoint and use of a laptop computer

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://www.iqvia.com.



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