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Clinical Trial Assistant

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)

Contract

Executive search

Experience

Minimum 3 years

Education

Higher Education

Languages

English, French

Sector

Other

Region

Louvain-la-Neuve

Job Type

Full-time

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