The ESA

Clinical Research Associate (CRA) / Clinical Study Coordinator (CSC)

European Society of Anaesthesiology , A non-profit European organisation acting as an academic CRO with a rapid growth and a “start-up” spirit is looking for a highly motivated in-house Clinical Research Associate/Clinical Study Coordinator to work on the ongoing projects and potential new trials. 

ESAis a non-governmental, non-profit organisation, exclusively and directly dedicated to promoting and coordinating the scientific, educational and professional activities of anaesthesiology in all European countries, and to serving the health care needs of the general public. The Society’s mission is to aim for the highest standards of practice and safety in anaesthesia and intensive care, perioperative, critical emergency and pain medicine through education, research and professional development throughout Europe.

If you are looking for a role in a multicultural environment that will increase your career progression opportunities and that will offer a rewarding working environment then please review and apply below.

Role Description

The Clinical Research Associate/ Clinical Study Coordinator will identify, select, initiate and close-out appropriate investigational sites for clinical studies. The successful candidate(s) will monitor these sites in order to ensure compliance to the study protocol, Standard Operating Procedures, applicable regulations, and the principles of ICH-GCP. The CRA/CSC will also be involved in project management operational team helping with the creation, review, maintenance and tracking of clinical trial documentation and other assigned tasks.

Responsibilities will include: 

  • Performing site qualification, selection, initiation, monitoring (on-site and remote) and close-out visits, and maintaining appropriate documentation for sites in Belgium. In a later stage, other countries might be in scope of monitoring.
  • Assist with the creation and completion of the Investigator Site File
  • Completion of monitoring reports and corrections
  • Maintaining Investigator Site Files and appropriate monitoring documentation
  • Establishing regular lines of communication (with CRO and site)
  • Providing protocol and related study training to assigned site personnel
  • Evaluating the quality & integrity of site practices – escalating quality issues as appropriate
  • Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution 
  • Preparation and attendance to site audits or inspections
  • Assisting with submission activities (if applicable)
  • Filing and Archiving paper wet-ink documents in the Trial Master File
  • Preparation of study related presentations, newsletters, etc,..
  • Creation, review, maintenance and tracking of clinical trial documentation

 Qualifications

  • University graduate, preferably with an academic focus in natural science, pre-medicine, pharmacy, nursing, or a related academic field.
  • At least 2 to 3  years of (on-site) monitoring experience
  • Thorough Understanding of the regulatory context, good clinical practices and standard operating procedures 
  • ICH-GCP certificate(less than 2 years old) mandatory, CRA certification is a plus
  • Experience with interventional studies and commercial Sponsor(s)
  • Previous CRO experience is an asset
  • Full working proficiency in English, Dutch and French
  • Proficiency in the use of the Microsoft Office ( Excell, Word and Powerpoint) 
  • Willingness and ability to travel (up to 50% for on-site visits)

Skills
  • Excellent communication skills (both written and oral) and the ability to build effective relationships with trial centre staff and colleagues;
  • Flexibility and Multi-tasking
  • Detail-oriented
  • Good organisational and administrative skills - the job involves a lot of documentation and recording of information through computerised processes such as clinical trial management systems and electronic data capture
  • Able to work efficiently and effectively in a dynamic environment

Location: Brussels (Office-based)

Contract Type : Full-time, Permanent

Availability: As soon as possible

How to apply?

Please send your CV and detailed motivation (in English) to sylvia.daamen@esahq.org  and gabrielle.dethioux@esahq.org