Clinical Trial Assistant (CTA)

Updated: April 04, 2024 10:13 PM GMT

NOVADIP Biosciences S.A.

Mont-Saint-Guibert

Your responsibilities

Primary Role

Trial Master File management and administrative support, in compliance with SOPs, ICH guidelines (including GCP) and all other EU/US legislations and directives relating to clinical research activities.

Nature and scope of responsibilities

1.Trial Master File (TMF) management from study start-up to close-out, ensuring all essential documents and relevant correspondence are filled in a timely manner.
• Development of TMF Plan in collaboration with Clinical Project Manager (CPM). o Set-up, maintenance, close-out and archiving of Sponsor TMF.
• Ongoing filing of documents and maintenance of related TMF inventory
• Assist the CPM with periodic reviews of the Sponsor TMF, including outsourced sections, as needed.
• Preparation and distribution of the Investigator Site Files. o Tracking of filed documents in Sponsor TMF and Investigators Site Files (ISF), and proactive alerting the CPM or CRA, as appropriate, on missing documents.

2. Administrative... More Detail