Join us as we speed the delivery of ground-breaking therapies and anticipate tomorrow's drug development challenges, creating new possibilities for our clients and your career.
We are searching for an In-House CRA to join our multi-sponsor team in Netherlands. This is a full-time position.
As an essential member of the Project Team, the IHCRAs are responsible for supporting the execution of clinical trials. IHCRAs work closely with their CRA colleagues to maintain quality and deliver study milestones.
Responsibilities include but are not limited to:
- Monitoring site performance and creating action plans for sites not meeting expectations, in conjunction with the on-site CRA
- Assist CRAs with the preparation for site visits (running reports, QC of files, resolving action items from previous visits)
- Liaise with the project team and others to distribute and track clinical trial supplies to ensure sites have enough to continue recruitment
- Perform Case Report Form review, query generation and resolution, assisting sites as needed
- Document review and collection to ensure compliance and inspection readiness of TMF
- Tracking and processing invoices from investigator sites against agreed contracts and budgets
- Undertake project related administrative tasks (meeting minutes, recruitment tracking, site document preparation)
- IHCRA may also be required to attend onsite monitoring visits as a co-monitor with experienced CRAs to assist with tasks such as site regulatory file review and drug accountability
Education and Qualifications:
- University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
- Research experience in pharmaceutical or CRO industries may be considered
- Good organizational and time management skills
- Good communication skills
- Existing experience as a CTA/IHCRA or Site Coordinator preferred
- Fluency in local office language and English