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 first experience with start-up activities (EC submission, study contract negotiation,...)?
- 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!
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.
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 degree
- A first experience with start-up activities is 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
- Work habits include organization, coordination of many tasks, accuracy, and attention to detail
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