Experienced Clinical research associate (CRA) - dedicated to one sponsor

For one of our clients, a sponsor with an innovating pipeline, we are looking for a Clinical research associate (CRA).

  • Do you have previous experience as Clinical research associate or Lead CRA? 
  • Are you a good communicator, able to express yourself in Dutch, French and English?
  • Do you have strong organisational and planning skills? 

This position is open for freelance consultants. Fulltime availability is a must. 

Don't hesitate to get in touch if you would like to receive more information. 

Job Description 

The Clinical Research Associate (CRA) is the primary point of contact between site staff and our client. In this role the CRA acts as ambassador for the company and contributes to making our client the preferred partner.

The CRA is responsible for taking leadership of site management for the initiation of sites as well as conduct and closing activities of the appointed studies in compliance with local regulations, ICH- GCP, company procedures and protocol requirements to ensure data quality and study subject protection. The CRA is responsible for managing the site to meet patient recruitment rate and target. The CRA thereby delivers results that have direct impact on the successful completion of the clinical programme.

  • Work within the respective country with one or more clinical trials, representing the local team in the CDC trial team led by the CDC Trial Manager, when applicable 
  • Primary point of contact between site staff and our client, act as an ambassador for the company and contributes to making our client the preferred partner in clinical trials
  • Contribute to or lead selection of sites, in collaboration with CDC and local colleagues such as LM and Medical Affairs
  • Overall site management, including site monitoring and remote monitoring as applicable
  • Ensure that trial site staff are properly trained to conduct the trial(s), provide necessary training and identify and flag any development areas and implement mitigations
  • Managing trial sites to meet patient recruitment and retention target, aimed at successful completion of the clinical programme
  • Close collaboration with relevant roles to ensure successful conduct of the trial, such as local Lead CRA, CDC Trial Manager, CDC CTA and local Line Manager 
  • Ownership of site management and trial conduct and timely flagging of any issues proactively to relevant roles within local team and/or CDC
  • Agree on tasks responsibility split and timelines with CDC CTA within the trial, including timely provision of trial documentation
  • Contribute to or drive Scientific Recruitment and Retention (SRR) planning and execution, in collaboration with CDC Trial Manager and as agreed with Line Manager
  • Perform local administrative tasks as agreed with the Line Manager
  • Responsible for site preparedness for audits and inspections and all related follow-up activities
  • Other relevant trial, site or documentation related tasks as assigned by line manager
  • Represent country in the CDC trial team
  • Ensure management and development of clinical sites within country
  • Collaboration with CDC Trial Manager and Clinical Trial Administration and other trial CRAs to ensure alignment of clinical operations processes across CDC countries
  • Bachelor's Degree level, life science or nursing qualification or equivalent (desirable)
  • Knowledge of clinical trial methodology
  • Knowledge of the clinical trials environment – ICH GCP, regulatory issues, SOPs
  • Knowledge of drug development process
  • Good working knowledge of electronic clinical trials systems – IMPACT, EDC, IWRS, electronic TMF
  • Computer literacy and IT skills
  • Previous experience of monitoring trials in accordance with ICH GCP methodology
  • Ability to work in changing environment to be agile and proactively find efficient ways of doing things
  • Fluency in French, Dutch and English
Contact Information 

Hilde Wolput
015 21 11 04

Application form : Experienced Clinical research associate (CRA) - dedicated to one sponsor

Files must be less than 3 MB.
Allowed file types: txt rtf html pdf doc docx odt.

I want to stay informed.

I would like to receive Valesta news, valuable insights into industry trends, career opportunities, trainings, and other helpful tips to find assignments that match my skills and interests. Click here to stay connected with Valesta.

Valesta is an expert in life science recruiting and project staffing.  The information you are submitting is important for us to respond to your assignment and contract needs. In compliance with the General Data Protection Regulation (EU) 2016/679) (“GDPR”), Valesta will process your personal data in accordance with our Privacy Policy. Valesta will safeguard your personal information and not disclose to any person unlawfully. As a staffing company, Valesta receives and processes your personal data for the following purpose: to take appropriate steps to find you an assignment with one of our clients and/or to finalise a contract with you.

Please note that Valesta does not wish to receive any data from you if you are under the age of eighteen (18) or data that is classified as Sensitive Data under the GDPR; this includes personal data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, trade union membership, genetic/biometric/health-related data or data concerning a person's sex life/sexual orientation.

Please read our disclaimer.