Lead Clinical Research Associate
IQVIA
Buenos Aires, Argentina
hace 17 horas

Essential Functions

  • Line Manager of Junior CRAs for vaccines protocols
  • Perform Accompanied Site Visits, on site and remotely with
  • appropriate reports, for the oversight of assigned CRAs; confirming the Monitoring visits and

    reports are performed with quality.

  • Review of weekly Timesheets, confirming tracked hours are in
  • accordance of the FTEs of the assigned protocols for the CRAs.

  • Oversight of CRAs Sponsor Training Compliance, CRO SOPs and follow up.
  • Participation of new hires interviews.
  • Development of CRAs skills.
  • One on one meetings with assigned CRAs.
  • Participation on Year Performance Review of assigned CRAs
  • Review of Visit Reports.
  • Perform Internal Line Group Meetings with assigned CRAs.
  • Participation as presenter on Regional Site call
  • Work with sites and assigned CRAs as main point of contact of
  • the Country; being also the main support for the Regional Clinical

    Lead, performing site and CRA training and oversight

    Qualifications

  • Bachelor's Degree Degree in scientific discipline or health care preferred. Req
  • Requires at least 4 years of year of on-site monitoring experience.
  • Equivalent combination of education, training and experience may be accepted in lieu of degree.
  • In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
  • Strong therapeutic and protocol knowledge as provided in company training.
  • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
  • Written and verbal communication skills including good command of English language.
  • Organizational and problem-solving skills.
  • Effective time and financial management skills.
  • Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
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