Associate Site Report Specialist

Project role : Associate Site Report Specialist

Work experiences : 4 to 6 years.

Work location : Homebased

Must have skills : CRA, Clinical Research Associate, Onsite Monitoring

Job overview :

Review Site Visit Reports (SVRs) to ensure they meet or exceed quality standards and support goals of quality, subject safety, data integrity and regulatory compliance. Use tools and techniques to ensure the efficient and effective review of Site Visit Reports and their associated attachments, in compliance with IQVIA SOP, ICH / GCP guidelines, and protocol requirements.

Job Responsibility :

Oversee a caseload of SVRs for assigned studies, ensuring compliance to the protocol, processes, timelines, IQVIA / applicable SOPs, and GCP guidelines

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 annotations

Provide coaching to CRAs to decrease the level of corrections / additions needed on reports.

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 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

Technical Skills :

4-6 years relevant experience Clinical Research Associate

Minimum of 3 to 4 years on-site monitoring experience

Basic therapeutic and protocol knowledge.