Senior Clinical Research Associate (SrCRA)

About the role

IQVIA Biotech, a full-service CRO serving biotech sponsors, is hiring a Senior Clinical Research Associate (SrCRA) in Argentina, with oncology preferred. The role covers monitoring and site management so that sites run studies according to the protocol, regulations and guidelines and report data as required.

Key responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) following the contracted scope of work and Good Clinical Practice.
• Work with sites to adapt, drive and track the subject recruitment plan in line with project needs.
• Administer protocol and study training to assigned sites and keep regular contact to manage expectations and issues.
• Evaluate the quality and integrity of site practices, escalate quality issues and track regulatory submissions, recruitment, CRF completion and data queries.
• Ensure site documents are available for the Trial Master File and that the Investigator's Site File is kept according to GCP and local requirements.
• Create documentation such as visit reports, follow-up letters and action plans, and liaise with the study team.
• If applicable, support the site-level recruitment plan and, if applicable, site financial management and invoice retrieval under the clinical trial agreement.

Required profile

• Bachelor's degree in a scientific discipline or health care preferred; equivalent education, training and experience may be accepted.
• At least 3-4 years of on-site monitoring experience.
• Good knowledge of and skill in applying clinical research regulatory requirements.