Job Overview :
Covance is looking to recruit a CTA to join our sponsor in Belgium!!
TRIAL AND SITE ADMINISTRATION :
Tracking (e.g. essential documents) and reporting (e.g. Safety Reports)
Ensure collation and distribution of study tools and documents o Update clinical trial databases (CTMS) and trackers
Clinical supply & non-clinical supply management, in collaboration with other country roles
Manage Labeling requirements and coordinate / sign translation change request
DOCUMENT MANAGEMENT :
Prepare documents and correspondence
Collate, distribute / ship, and archive clinical documents o Assist with eTMF reconciliation
Updating manuals / documents (e.g., patient diaries, instructions) o Document proper destruction of clinical supplies.
Prepare Investigator trial file binders o Execute eTMF Quality Control Plan o Obtain translations of documents
REGULATORY & SITE START-UP RESPONSIBILITIES :
Provide to and collect from investigators forms / lists for site evaluation / validation, site start-up, and submissions
Obtain, track and update study insurance certificates
Support preparation of submission package for IRB / ERC and support regulatory agencies submissions.
Publish study results for GCTO and RA were required per local legislation
BUDGETING, AGREEMENT, AND PAYMENTS :
Collaborate with finance / budgeting representatives for :
Develop country and site budgets (including Split site budget) Tracking, and reporting of negotiations
Maintenance of tracking tools
Contract development, negotiation, approval, and maintenance (e.g. CTRAs)
Update and maintain contract templates (in cooperation with the Legal Department)
Payment calculation and execution (investigators, vendors, grants)
Ensure compliance with financial procedures
Monitor and track adherence and disclosures,
Education / Qualifications :
Bachelor of Science degree preferred or an equivalent scientific or commercial Higher Vocational Education with preferably experience in the healthcare field, pharmaceutical industry or clinical research.
Experience : Experience :
Minimum 1-2 years in Clinical Research or relevant healthcare experience
Fluent English, French and Dutch
If you would like to learn more :
31 (0) 61 293 9571