Site Report Quality Assurance Professional

1 week ago

Gulbarga, Karnataka, India beBeeQualityAssurance Full time ₹ 9,00,000 - ₹ 12,00,000

Job Summary:

We are seeking a skilled Associate Site Report Specialist to join our team.

In this role, you will be responsible for reviewing Site Visit Reports (SVRs) to ensure they meet quality standards and support goals of quality, subject safety, data integrity, and regulatory compliance.

  • You will oversee a caseload of SVRs for assigned studies, ensuring compliance with protocol, processes, timelines, IQVIA SOPs, and GCP guidelines.
  • You will provide guidance to Clinical Project Managers (CPMs) at project start-up and throughout the study, partnering with the project team members to decrease corrections/additions needed on reports.
  • You will coach CRAs to decrease the level of corrections/additions needed on reports.
  • You will identify and track project team compliance to SOPs for submission and approval of SVRs through communication with CRAs and line managers.
  • You will participate on the project team for all SVR review activities and identify/escalate CRA and/or site issues, relevant trends, and related risk factors to optimize quality of project delivery.

Requirements:

  • 4-6 years relevant experience as a Clinical Research Associate.
  • Minimum 3-4 years on-site monitoring experience.
  • Basic therapeutic and protocol knowledge.

About the Role:

This is an excellent opportunity to develop your skills in SVR review and contribute to the success of our projects.

You will have the chance to work closely with a dedicated team of professionals who share your passion for delivering high-quality results.

The ideal candidate will possess strong analytical and problem-solving skills, with the ability to communicate effectively with stakeholders.

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