Research Associate Lead

hace 2 meses

Buenos Aires, Argentina IQVIA A tiempo completo
Job Description

Job Summary:

We are seeking a highly skilled and experienced Senior Clinical Research Associate to join our team at IQVIA. The successful candidate will be responsible for overseeing the preparation and execution of Phase I-IV clinical trials, ensuring compliance with Good Clinical Practices and procedures set forth by IQVIA and sponsors.

Key Responsibilities:

  • Participate in the preparation and execution of clinical trials, including site evaluation, initiation, and close-out visits.
  • Oversee the progress of clinical investigations, ensuring compliance with Good Clinical Practices and procedures.
  • Collaborate 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 site personnel the protocol, regulatory issues, study procedures, and providing training on completion of the eCRF.
  • Conduct on-site monitoring visits to ensure adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures.
  • Prepare monitoring reports and letters per the timelines defined in IQVIA SOPs.
  • Document accountability, stability, and storage conditions of clinical trial materials as required by sponsors.
  • Review the quality and integrity of clinical data through in-house review of electronic CRF data and on-site source verification.
  • Work with sites to resolve data queries and ensure timely transmission of clinical data.
  • Perform study close-out visits per the study-specific Clinical Monitoring Plan.
  • Assist with and attend Investigator Meetings for assigned studies.
  • Authorized to request site audits due to data integrity concerns.
  • Attend study-related, company, departmental, and external meetings as required.

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.
  • 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.

About IQVIA:

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.

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