Clinical Research Professional
Current- Medical writing (e.g. clinical evaluation plan and report, clinical investigation plan and report, monitoring plan, statistical analysis plan, data management plan, scientific publications)- Competent authority and ethics committee submissions- Project and investigational site management of (inter)national clinical trials with medical devices- Providing support in the start-up, enrollment, follow-up and closure of clinical trial activities- Ensuring that the rights and well-being of subjects are protected and that the study data are accurate and verifiable from source documents- Ensuring that the milestones, timelines, budgets and quality of clinical trials are met as outlined in protocols, SOPs, ISO/GCP and the applicable regulatory requirements- Sponsor, investigator and vendor interactions
