XPE Pharma & Science is looking for a CRA for a pharmaceutical company situated in Merelbeke (Ghent).

General Description

The CRA is responsible for the organization and progress of 1-5 international Phase II-IV studies in Belgium.
The CRA is part of the international Monitoring and Study Management Group of our client.
For each study he is also part of an international study team consisting of 7 to 50 persons.

Key responsibilities & accountabilities

Accompaniment and coordination of clinical drug research from receipt of the feasibility assessment till archiving of the study in accordance with the applicable local and international guidelines and procedures (SOP's) in order to meet all the requirements necessary for global registration of a new drug.

• Clinical drug research:
  The creation, coordination, monitoring and closure of clinical drug research, according to agreed Key Performance Indicators (KPIs) from feasibility and archiving in consultation with Head Monitoring and Study Management (HMStM) BeLux and Study Manager so that the clinical drug research is carried-out in accordance with all the applicable guidelines.
• Budgets:
  Detailed preparation, negotiation and monitoring of the budget of a particular study for Belgium in consultation with the HMStM BeLux and the Study Manager to ensure the study can be carried-out within the existing budget.
• Country Lead Monitor (optional, depending on opportunity and/or experience of candidate):
  Leading a BeLux study team (Junior CRA's and Clinical Trial Assistant (CTA), monitoring the progress of the study and ensure the progress and management of the budget for the BeLux, in coordination with the HMStM BeLux and Study Manager.
• Knowledge & information management:
  Keep the knowledge & information on clinical drug research up-to-date and weekly update of Impact (the system where all data are collected on a study) in consultation with HMStM BeLux to ensure that all studies in Belgium are in accordance with the applicable guidelines.
• Quality:
  Participate in (international) expert working groups in accordance with the applicable guidelines to write a new SOP or improve existing SOP programs.
• Give support to the Medical BeLux department:
  Give support to the BeLux study teams and/or the medical department BeLux on the study registration systems and related databases in accordance with the guidelines for information transfer and solving problems of the systems.

Required education & skills

• University or higher non-university degree in a paramedical science.
• Minimum 1,5-2 years experience as a CRA (preferably in Oncology) in a pharmaceutical company or CRO.
• Accuracy, team work, ability to plan and organize.
• Flexibility, persuasiveness and willing to take initiatives.
• Management of ICH-GCP guidelines and local laws.
• Good communication and contact skills.
• Good command of Dutch, English & French (spoken and written).
• Good command of MS Office Word, Excel, Powerpoint & Lotus Notes.