Site Review Specialist

4 days ago


Mangalore, Karnataka, India beBeeClinical Full time ₹ 15,00,000 - ₹ 20,00,000
Job Overview

The primary responsibility of this role is to review site visit reports and ensure they meet quality standards and support goals of quality, subject safety, data integrity, and regulatory compliance.

  • Oversee a caseload of site visit reports for assigned studies, ensuring compliance to the protocol, processes, timelines, IQVIA SOPs, and GCP guidelines.
Key Responsibilities:
  • Provide guidance to clinical project managers at project start-up and throughout the study, partnering with the project team members to decrease the level of corrections/additions needed on reports.
  • Coach CRAs to decrease the level of corrections/additions needed on reports.
  • Identify and track project team compliance to SOPs for submission and approval of site visit reports through communication with CRAs and line managers.
  • Participate on the project team for all site visit review activities and identify and escalate CRA and/or site issues, relevant trends, and related risk factors to the project team and appropriate parties in a timely manner to optimize quality of project delivery.
Required Skills and Qualifications:
  • A minimum of 4-6 years of experience as a clinical research associate.
  • A minimum of 3-4 years of on-site monitoring experience.
  • Basic therapeutic and protocol knowledge.

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