Would you like to work for a well-known advanced biotechnology company located in the Walloon Brabant? Do you have a previous experience as CTA, even for 1 year? Or do have a first administrative experience in the clinical research? Then we have the job for you!!"
Our client is a biotechnology company specializing in the development of cell therapy products for bone fracture repair and fracture prevention. At the forefront of science
and medicine and leader in its field, the Company is developing innovative regenerative products, containing bone-forming cells, using its proprietary stem cell-based technology
platform. With its strong portfolio of clinical programs (Phase II and Phase III) and preclinical programs, our client is organized as a "mini-pharma", with departments for preclinical
research, clinical studies, production, quality control, quality assurance, regulation and administration.
To strengthen their growing organization, they are looking for a « Clinical Trial Assistant » (F/M).
Reporting to the Chief Medical Officer (CMO), you will ensure the administrative and logistics management of the clinical trials, what includes their implementation, follow-up and closure in
compliance with the regulations in force, Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs).
- Creation and updating of the permanent study file (general file and center files) and files intended for investigators;
- Ensure the study documentation complies with the Standard Operating Procedures (SOPs);
- Updating and maintaining documentation and ensuring the traceability of documents related to clinical development ;
- Preparation and shipment to the clinical sites of any information document ;
- Preparation and coordination of the Investigator, experts Meetings and other clinical department meetings;
- Participation and support to the implementation of Standard Operating Procedures (SOPs) ;
- Creation and update of the permanent study record (Study & Site TMFs) as well as Investigator Site Files (ISFs) ;
- Support to the creation of the clinical and regulatory documentation (study plan and study protocol, summary, CRF, IB, monitoring plan, IND/IMPD, etc.) ;
- Support the Clinical Study Manager with the development, follow up and submission of all publications being developed as a result of clinical department activities;
- Filing, coding and archiving of the study-related documentation ;
- Continuous update of the Sponsor documentation and responsible for ensuring the traceability of the clinical development documents;
- Update of the site tracking tools;
- Support in the management of clinical contracts and invoices;
- Maintain the communication between the Investigators and the Sponsor in the absence of the Clinical Research Associate (CRA) ;
- Responsible together with the Clinical Research Associate for handling the phone calls and correspondence from the clinical sites;
- Documentation of any monitoring activity (minutes, phone call, reports, correspondence, etc.) ;
- Transfer of information to the Clinical Study Manager ;
- Organization of the site visits together with the Clinical Study Manager and Clinical Research Associate ;
- Assessment of the inventory stock status and refill of the investigational drugs and site material together with the CRA ;
- Management of the investigational drug and material orders, verification of the on-site shipment and receipt status.
- Higher education degree or degree in the paramedical field and/or administrative management. An equivalent professional experience is a strong asset;
- Notions of clinical trial administrative management ;
- The knowledge of ICH-GCP and SOPs used in clinical research is a strong asset;
- French and English fluent. Dutch and German are an asset;
- Being aware of the Quality Assurance principles ;
- Being able to use commonly the Microsoft Office suite (Word, Excel, Power Point) and
- Accuracy and rigor ;
- Good work organization, speed of operation ;
- Sense of initiative and observation, team spirit ;
- Analytical and problem solving skills ;
- Adaptability, autonomy and flexibility ;
- Being able to adapt to different interlocutors
- A balanced salary package based on your capabilities and experience, including meal vouchers.
- A fulltime position
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number: 17314