Site Report Specialist

2 days ago

Ahmedabad, Gujarat, India Cliantha Research Full time ₹ 6,00,000 - ₹ 12,00,000 per year

Role & responsibilities

  • Oversee a caseload of SVRs for assigned studies, ensuring compliance to the protocol, processes, timelines, Quintiles/applicable SOPs, and GCP guidelines. Review SVRs to ensure findings requiring corrective and /or preventative action plans are documented and followed up to resolution, to ensure high quality reports.
  • Participate on the project team for all SVR review activities and identifies 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.
  • Provide guidance to Clinical Project Managers (CPMs) at project start-up and throughout the study and partner with the project team members to decrease the level of corrections/additions needed on reports by providing insight and training of the SVR worksheet.
  • Identify and track the project team compliance to SOPs for submission and approval of the SVRs through communication with the CRAs and line managers.
  • Participate in meetings with project team to discuss any SVR review issues illustrative of quality/performance deficiencies across PIs/sites and CRAs. Assist with identification of the trends emerging from the Issue Escalation.
  • Provide coaching to decrease the level of corrections/additions needed on reports.
  • Provide quality improvement support such as quality checks, data trending, providing back up support and mentoring and coaching of junior staff members.
  • May take on special project assignments related to function/corporate initiatives.

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