Clinical Trial Assistant (CTA) Fr/En
Clinical Trial Assistant opportunity within an Innovative Biotech company
Over de organisatie
Our client is a clinical stage biotech company located in Walloon Brabant. To join their Clinical Research Team, they are currently looking to recruit a Clinical Trial Assistant (CTA).
Jouw nieuwe functie
The CTA's primary responsibility consists in the Trial Master File (TMF) management and administrative support to the team, and this in compliance with SOPs, ICH guidelines (including GCP) and all other EU/US legislations and directives relating to clinical research activities.
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.
2. Development of TMF Plan in collaboration with Clinical Project Manager (CPM). o Set-up, maintenance, close-out and archiving of Sponsor TMF.
3. Ongoing filing of documents and maintenance of related TMF inventory
4. Assist the CPM with periodic reviews of the Sponsor TMF, including outsourced sections, as needed.
5. 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.
6. Administrative support to Clinical Operations Team, including but not limited to: o Assistance with the planning and preparation of internal and external meetings, including preparation of minutes and on-site support of Investigators Meetings.
7. Formatting of clinical trial documents / manuals and arranging their translations.
8. Assistance with preparation and distribution of Newsletters / Site Correspondence. Creation and maintenance of the study contact lists.
9. Data entry into designated clinical tracking systems in accordance with project requirements o Assistance with regulatory submissions / notifications, as needed, including but not limited to support with the preparation of Ethics Committee submissions, compiling the required documents, uploading of files on CTIS or other required platforms.
10. Preparation, handling, distribution and tracking of Clinical Trial Supplies
Jouw profiel
11. Bachelor degree in administration / secretary; heath related degree is a plus
12. Prior experience as Clinical Trial Assistant
13. Familiar with ICH-GCP and Documentation management
14. Excellent English knowledge (written, spoken, understanding), French and Dutch are a plus.
15. Excellent Computer Skills
16. Excellent organizational and communication skills (hands on personality)
17. Flexibility to operate in multitasks environment
De arbeidsvoorwaarden
A temp to perm opportunity