Clinical Trial Assistant

As a CTA you are a key member of a clinical trial team and responsible for the operational support during start-up, execution and closing of clinical studies. Function: key responsibilities (level of involvement may vary amongst companies): - Involved in set-up and maintenance of study specific Trial Master File (paper TMF or eTMF) including reconciliation and archival - Accountable for the timely tracking and review of essential study documents for assigned clinical studies, ensuring completeness, accuracy and compliance with study protocols, company SOPs, GDPR, ICH-GCP, ISO 14155 and applicable local regulations. - Support and assist the team with critical operational aspects of the trial, such as site activation and site closure activities May be involved in the preparation and submission of study-related dossiers to CA and EC - Responsible for the set up and maintenance of study site files and study-related documents - Support maintenance of the Clinical Trial Monitoring System (CTMS) or similar trackers by data entry of the applicable information upon receipt - Support the organisation of study-related meetings, for example Investigator – and Steering Committee meetings - Support drug/device accountability, as applicable - Manage the inventory of study supplies and support/track shipment of study supplies to study centers, core labs and other vendors, as applicable - Liaise with study sites and establish good communication lines with various departments - Coordinate translations of study documents - Coordinate and follow up of site payments and vendor payments. Support the review, processing, and tracking of invoices, as applicable - Communicate and support process improvement initiatives whenever applicable Interested in this job? Send us your CV and motivation to: staffing@triumclinicalconsulting.com