INHOUSE CLINICAL RESEARCH ASSOCIATE (CRA) - START-UP NETHERLANDS

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),...

Responsibilities 

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.

Profile 
  • 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

chantal.rozeboom@valesta.com

(0032) 015 21 11 04

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