Job opportunities

Job description

A biotechnology company specializing in the development of cell therapy products for bone fracture repair and fracture prevention. To support our Clinical Team, we are looking for a Clinical Trial Assistant:

Reporting to the Chief Medical Officer, 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).

JOB DESCRIPTION  

• Ensure the administrative support of the clinical studies in compliance within the agreed-upon timelines ;
• Ensure the study documentation complies with the Standard Operating Procedures (SOPs) ;
• Maintain the communication between the Investigators and the Sponsor in the absence of the Clinical Research Associate (CRA) ;
• Ensure the stock management and shipment of the investigational drugs and study material in the absence of the Clinical Research Associate (CRA) ;
• Preparation and shipment to the clinical sites of any information document ; review of sites and CRO invoices
• Preparation and coordination of the Investigator 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) ;
• Support to the creation of the clinical and regulatory documentation (study plan and study protocol, summary, CRF, IB, monitoring plan, IND/IMPD, ) ;
• 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 and preparation of status reports
• Responsible together with the Clinical Research Associate for handling the phone calls and correspondence from the clinical sites ;
• Documentation of any monitoring activity (phone call report, correspondence, ) ;
• Transfer of information to the Clinical Study Manager and to Regulatory Manager
• Organization of the site visits together with the Clinical Study Manager and/or CRO (co-monitoring visit);
• Assessment of the inventory stock status to assist CRO and /or internal clinical supplies department
• Management of the material orders (labs kits, etc), verification of the on-site shipment and receipts status when applicable. 

SKILLS

• Higher education degree or degree in the paramedical field and/or administrative 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.
• Being aware of the Quality Assurance principles ;
• Being able to use commonly the Microsoft Office suite (Word, Excel, Power Point) and Internet search tools ;
• Accuracy and rigor ;
• Good work organization, speed of operation ; proactivity
• Sense of initiative and observation, team spirit ;
• Analytical and problem solving skills ;
• Adaptability, autonomy and flexibility ;
• Being able to adapt to different

OFFER

• Immediate start
• 3 days per week
• 6 months renewable
• Position based Wallonia partially (+ home based)