For one of our clients, a known pharmaceutical company in Brussels region, we are urgently looking for a CRA for phase 4 studies.
This position is open for candidates with a first experience in clinical research (f.e. as CTA, inhouse CRA, study nurse,...)
Don't hesitate to get in touch for more information!
- May support in operational feasibility to assess feasibility of trial in Belgium.
- Nominate in close collaboration with Medical Advisor and CSM new sites for clinical trials; analyze capability and make recommendation for trial inclusion.
- Assume ambassadorial role to facilitate communication between sites and line functions and increase value proposition to investigators.
- Facilitate preparation and collection of site level documents; resolve problems as required.
- Create and oversee entire site management of smaller trials, including initiation and training, monitoring and close-out visits, regulatory assessment, drug supply management and resolution of site problems to ensure compliance.
- Track trial execution milestones;
- Manage recruitment with support of CSM and IGH and execute contingency plans, if needed.
- Assure preparation/generation of study visit monitoring reports.
- Manage data at the site; resolve technical and content issues to achieve aggressive database lock targets.
- Participate in multi-disciplinary teams within CPO and globally to evaluate and implement process improvement.
- May act as local and/or global “Lead CRA” and author global monitoring plan for smaller or non-complex trials.
- May support and perform site contract negotiations (in close collaboration with CSM and/or IGH).
- May monitor trial costs and budget (in close collaboration with CSM) and identify problems; resolve issues and escalate as appropriate.
- Degree in a scientific or health care discipline strongly preferred.
- Dutch, English and French
- Desired 1-3 years experience in clinical research or having demonstrated adequate level of proficiency within the CRA competency profile.
- Understands and can apply knowledge of clinical trial designs to trial execution.
- Knowledge and experience in international Standards (GCP/ICH), international (FDA,EMA) and local regulations.
- Proven expertise in effective communication, in managing multiple priorities and in computer literacy.
015 21 11 04