For one of our clients in Brussels region, we are looking for an inhouse Clinical research associate (CRA), who will take care of start-up activities, with focus on the Netherlands.

  • Do you have a good knowledge of the Dutch market?
  • Are you a good communicator and fluent in Dutch and English?
  • Are you a good organizer, able to meet deadlines?

Then this might be the ideal job for you! Don't hesitate to get in touch!

Job Description 

You assist in the start-up of clinical studies. You are responsible for regional start-up activities for your assigned region (including EC submission, ICF review and customization, Study contract negotiation)

You are also lead CRA (not monitoring related) for assigned studies (coordination of regional in-house CRA, and take care of SSU activities that are not linked to a region, such as ensuring Insurances certificate have been requested, patient material (E.G. patient brochure),...


Provides support in start up, enrollment, follow up and closure of clinical trial activities as regional in-house CRA for assigned region. Ensure coordination of mainly start-up and closure activities as lead in-house CRA for assigned studies.

In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.



Key Responsibilities

As Regional in-house CRA (for assigned sites):

  • Request /collection of relevant (i.e. Regulatory Docs, FDF, CV/ML) investigator / site documentation
  • Ensure submission to Ethicals committees following country/region regulations
  • Review and upload documents in applicable database
  • Reviews/adaptation of ICF
  • Manages study contracts (negotiate content & budget)
  • Ensure translation are done by appropriate vendor when required
  • Authorize site to enroll when all required processes are completed and docs collected
  • Participation on Audit preparation activities
  • Closure activities

As Lead in-house CRA (for assigned studies):

  • Work in close collaboration with study Clinical Trial Manager (CTM) to setup start-up phase of the study
  • In collaboration with CTM creation of patient materials
  • Ensures an appropriate communication of the start-up status during core team calls or any other meetings related to the study
  • Coordinations of the activities of Regional in-house/field CRAs assigned to the study
  • Coordinations of the SMF annuals quality checks with managers and assigned CRAs
  • Management of the team rosters
  • Participation on Audit preparations activities
  • Coordination of closure activities with Regional in-house/field CRAs

Communications: ensures clear communication to clinical sites and project team members through study core team meetings, by owning site start-up calls, escalation of issues when appropriate

Collaboration: participates in study-specific meetings, teleconferences and trainings.Collaborates with cross-functional team members and study sites throughout all study phases.

  • A Bachelor/Master degree
  • A first experience with start-up activities in the Netherlands is an asset, but not required
  • Must have demonstrated strong written and verbal communication, interpersonal, presentation, analytical, organizational skills
  • The ability to work independently when necessary
  • A general familiarity with clinical trials research processes is an asset
  • Fluent knowledge of Dutch and English, a good knowledge of French is an asset
  • Work habits include organization, coordination of many tasks, accuracy, and attention to detail

Contact Information 

Chantal Rozeboom

(0032) 015 21 11 04


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