As Clinical Research Associate you are responsible for and central point of communication for the company and Investigators for site-related clinical trial activities to assure trials are adequately conducted on time, while fully GCP, ICH and SOP compliant.
May leads local trial team to coordinate on the local CPO and/or the global level for a limited number of small clinical trials in different complexity levels, when assigned.
Responsibilities
- 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.
Profile
- Degree in a scientific or health care discipline strongly preferred.
- Dutch and English (fluent oral and written), French preferred
- Basic medical and business knowledge.
- 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.
