Date:
Tuesday, September 24, 2013

The European Cystic Fibrosis Society - Clinical Trials Network (ECFS-CTN) is looking to appoint a Standardisation Committee Coordinator.

The ECFS-CTN (http://www.ecfs.eu/ctn) is a network of independent specialist Cystic Fibrosis Centres across Europe who have voluntarily formed an alliance to improve the outcome of patients with cystic fibrosis (CF).  The network currently comprises 30 CF centres in 11 European countries. CF is a rare and complicated inherited disorder. This life shortening disease occurs throughout the world with an incidence as high as 1/2000 in some European countries. Improved treatment schedules have led to a better survival.  The aim of the ECFS-CTN is to intensify clinical research in terms of quality and quantity to ensure people with CF have access to effective treatment as quickly as possible.

The Standardisation Committee Coordinator will be responsible for the development and review of Standard Operating Procedures (SOP), exhaustive literature searches and systematic review of information on outcome measures in order to develop SOPs, development of training procedures and certification process.  His/her role and required skills will include:

Expert communication

  • Effectively and tactfully communicate with network partners.  The incumbent reports to the Chair of the Standardisation Committee, which includes 7 groups of international experts.
  • The incumbent will work closely with the ECFS-CTN coordinating personnel located in Belgium.

 Management

  • Coordinate training/certification of new sites.
  • Monitor the activities of the Standardisation Committee’s expert groups for timely progress of projects

Administration and Travel

  • Develop, review, and distribute Standard Operating Procedures.
  • Write reports and provide presentations.
  • Organise teleconferences.
  • Organise meetings (Standardisation Committee).
  • Maintain records of site/individual training and certification status.
  • Attend the meetings of the ECFS-CTN, the annual ECFS conference and the North American CF Conference.
     

Ethical/Legal management/Quality assurance and control

  • Get acquainted with the different European Institutional Review Boards / Research Ethics Committees, European legislation about research in humans
  • Good knowledge of Good Clinical Practice Guidelines
  • An understanding of  the Pharmaceutical Industry and Clinical Trials
  • Committed to quality and standardisation

 Job Profile

  • University degree or equivalent training
  •  Fluent in English (written and oral)
  • Training and experience in Good Clinical Practice (GCP)
  • Experience in health care and/or clinical trials (particularly the area of respiratory health)
  • Knowledge of how to perform systematic reviews
  • Knowledge of the evaluation of clinimetric properties
  • Positive problem solving attitude and team worker
  • Highly skilled in managing complex projects
  • Highly organised and detail orientated
  • Computer skills: Email, Word, Excel, PowerPoint, Access
  • Ability to work independently and flexibly at a distance from team members
  • An understanding of the pharmaceutical industry and clinical trials

 What we offer:

  • A challenging job in a stimulating environment
  • A job that makes a difference
  • A job with an international flavour

Please send curriculum vitae and cover letter (no later than: 25 October 2013) to:

European Cystic Fibrosis Society
Christine Dubois
Kastanieparken 7
DK-7470 Karup
Denmark
christine.dubois@ecfs.eu