Senior Clinical Research Associate (Sr. CRA)

About the role

IQVIA Biotech, a full-service CRO serving biotech sponsors, is hiring a Senior CRA 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 and escalate quality issues as appropriate.
• Track regulatory submissions and approvals, recruitment and enrollment, CRF completion and submission, and data query generation and resolution; may support the start-up phase.
• Ensure site documents are available for the Trial Master File and that the Investigator's Site File is maintained according to GCP and local regulations.
• Create and maintain documentation such as visit reports, follow-up letters and action plans.
• Liaise with study team members; may also support site recruitment plans and site financial management and invoice retrieval.

Required profile

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