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The European Forum for Good Clinical Practice (EFGCP) is searching for an

ASSISTANT PROJECT COORDINATOR

Position
Full-time Assistant Project Coordinator
with project management experience and understanding of the clinical research environment to be hired and employed by EFGCP and responsible for the day-to-day activities of a FP7 funded project management and coordination.

Period
1 January 2008- 31 December 2008

The European Forum for Good Clinical Practice (EFGCP)
is a not-for-profit, independent international association located in Brussels, established by and for individuals with a professional involvement in the conduct of biomedical research. Its purpose is to promote good clinical practice and encourage the practice of common, high-quality standards in all stages of biomedical research throughout Europe. The EFGCP does this by promoting contact and partnership between the major disciplines and organisations affected by good clinical practice: pharmaceutical companies; contract research organisations; suppliers of services, systems and equipment; academia; investigators; ethics committees; regulatory authorities; patient organisations; etc. For the past 14 years the EFGCP has provided a high-level meeting place and think tank for ethics and science in European biomedical research.

The ICREL Project
This FP7 project funded by the European Commission aims at analysing and measuring the impact of the Directive 2001/20/EC and related legislation on the EU industry and academic clinical research. This initiative fits with the need to adapt the current legislation, and will help determine which are the most relevant pathways for improvement. The Directive 2001/20/EC was adopted with the objective of harmonising the EU regulatory environment, of improving the protection of participants, of optimising the use of safety information, and of ensuring the credibility of data, through a strengthened responsibility of the sponsors and member states. However, this legislation only protects participants in clinical trials on medicinal products. It requires almost similar procedures for all types of clinical trials with medicinal products from registration studies on innovative treatments to studies comparing treatment strategies using marketed drugs and minimally invasive studies. SMEs including biotechnology companies and academic institutions face major difficulties in fulfilling their sponsor’s responsibilities. The Clinical Trials Directive’s objectives were transposed into divergent national legislations, partly missing the harmonisation goal and making especially multi-national trials difficult to perform. This raises concerns on the competitiveness and attractiveness of the EU for clinical research. The current project is designed to measure the impact of the current EU legislation, analysing its direct and indirect consequences on all the categories of clinical research through information compilation and surveys: to Industry and SMEs, on non-commercial trials, on clinical research other than clinical trials on medicinal products, on the impact on competent authorities, pharmacovigilance, monitoring, clinical trials infrastructure and funding and on the impact on ethics committees and protection of participants.
The results of this project will be discussed during a final meeting, then published and disseminated. The participants are institutions involved in various aspects of clinical research at the EU level, able to both collect data from, and disseminate the outcome to their respective community (industry, academic research, competent authorities, ethics committees) throughout the EU.

Main Responsibilities

Assisting the Project Coordinator with the overall coordination and administration of this European project:

- Performing the administrative and financial management of the project
- Contributing to the quality system development and to the procedures elaboration
- Organising and minuting all Project Committee Meetings and tele-conferences
- Taking part in the implementation and the management of the project with the partners’ representatives
- Supporting the technical preparation and the dissemination of questionnaires
- Coordinating the work packages activities
- Controlling the quality and timely release of the survey reports including the draft conclusions
- Preparing and releasing the financial report
- Organising the Final meeting
- Supporting the physical compilation, quality control and dissemination of the Final Report

Required Qualifications & Skills

• Experience in project management, preferably in a European or international context
• Excellent written and oral communication skills
• Fluency in spoken and written English; French is an asset.
• Well organised and caring for details
• Excellent time management and respect of deadlines
• Strong computer skills, including databases
• Creative and resourceful problem solving abilities

The applicant should have strong interpersonal skills and be able to work in a team environment.

Benefits

• Competitive salary package
• Part of small & friendly team
• Nice office in the heart of the European district (very good public transport connections)

Application

Applications should include an up-to-date curriculum vitae in English, a one-page cover letter in English and be sent BY 17 DECEMBER 2007, by e-mail, post or fax to:

Fanny Senez, Chief Operating Officer, EFGCP Secretariat - Square de Meeûs – Rue de l’Industrie 4, BE-1000 Brussels, Belgium - Tel: +32.2.732 87 83 / Fax: +32.2.503 31 08 / E-mail: fsenez@efgcp.be