Study Start-up CRA

For a pharmaceutical company, we are looking for a Study Start-up CRA.  Our client is very flexible with respect to working hours and homebased working.  If you don't want to be on the road all the time but still like to have a crucial role in clinical trials, this is the job for you!

  • Do you have experience in site monitoring, as study co-ordinator and/or with study start-up activities
  • Are you fluent in English with a good knowledge of Dutch and French
  • Do you want to expand your project management skills via study oversight activities

Then this is the step in your career that you have been waiting for! 

Job Description 

As a Study Start-up CRA you will be managing and overseeing all Study Start-Up related activities, in collaboration with the involved clinical research stakeholders. Next, you are responsible for clinical trial oversight activities.

  • You execute all start-up activities prior to site activation on the assigned studies
  • You coordinate protocol and site level feasibility activities, including evaluation of patient population and final site selection
  • You provide clinical trial oversight to the local study teams
  • You coordinate the operational aspects for implementation of the clinical trial activities
  • You are involved in the negotiation of site budgets, budget plans and you provide oversight for site payments 
  • You manage the communication with local study teams and to sites as required
  • You give support in the management of country-level Trial Master File (TMF) and reviews for quality (including translations, as applicable).
  • You update regulatory requirements, ensure adherence and compliance with local regulations and internal procedures.
  • You are responsible for the preparation of Informed Consent Forms (ICF) and obtain ethics committees' and local regulatory authorities' approval. You prepare ongoing submissions, amendments and periodic notifications.
  • You are the liaison for communications with relevant authorities/bodies to further enhance the clinical trial process
  • You submit, according to local regulatory requirements, all Suspected Unexpected Serious Adverse Reactions (SUSAR)
  • You provide feedback to local vendor managers and CRA's
  • You are responsible for the coordination of local affiliate study level audits and inspection audit action plan activities.
  • University degree in a scientifical field or equivalent by professional qualification
  • Demonstrated knowledge and understanding of clinical trials (study start-up + CRA/studyco experience ) and experience in managing projects 
  • A strong understanding of Good Clinical Practices (ICH-GCP), as well as an understanding of the regulatory, ethics and contractual requirements for starting clinical trials in relevant countries.
  • Very good language skills (English, Dutch, French)
  • Excellent communication skills
  • High work standards, strong decision-making skills and able to adapt to varying conditions
Contact Information 

Nele Daems
015 21 11 04

Application form : Study Start-up CRA

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.