Study Start Up Associate, (Europe, homebased) – IQVIA Biotech
Responsible for the quality and regulatory compliance of Principal Investigator (PI) credentials and Essential Documents (ED) during the start-up period of the study. Work with both internal and external teams to assure good communication, regarding start-up activity. Assure documents maintained for start-up of a study are in compliance with International Congress on Harmonization-Good Clinical Practices (ICH-GCP) and country specific procedures set forth by IQVIA Biotech and its clients. A Study Start-up Associate I will work in conjunction with or under the supervision of a more senior SSU Associate or members of the study start up team.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
• Supports the SSU Manager or SSU Lead to provide updates during weekly client teleconferences and internal team meetings, as required.
• May Assist in the dissemination of Confidential Disclosure Agreements (CDAs) and feasibility questionnaires to sites and follows up with sites accordingly to ascertain interest and to meet study timelines.
• May participate in the review and negotiation of the CDAs according to country specific requirements.
• Support the SSU team as required to send regulatory packets/documents to selected sites and/or follows-up with sites on the start-up process at the site.
• Support the SSU team as required to collect essential regulatory documents required to activate a site according to the study specific Essential Regulatory Document Checklist.
• Compiles and completes a review of these regulatory documents into a complete “green light package” (GLP), performing a final review prior to submission for final sign-off.
• Once GLP is complete, submits for final sign-off and works with the final reviewer and SSU team to resolve any findings and/or queries.
• Responsible for transitioning sites from SSU to Site File Operations representative
• Adheres to study timelines, documents/escalates study challenges, and communicates updates to SSU Manager and/or SSU Lead and/or Line/Study Management.
• Maintains up to date and accurate tracking on the start-up status for each site in applicable system(s) for the study.
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