İlan Detay

Occlutech Tıbbi Ürünler - Clinical Research Associate

Job Definition

  • Plan, prepare and manage all monitoring related activities, the performance of monitoring of trial/registry sites
  • Conduct clinical trials, clinical studies, and registries according to all applicable regulations, to commonly accepted practices, and to Occlutech’s internal guidelines, i.e.
  • Prepare Essential documents according to ISO 14155, MDR
  • Care for submission-approvals by Competent Authorities and favorable opinions by responsible Ethics Committees
  • Plan and track the course of the studies and update tracking lists
  • Liaise with study investigators and site staff on a regular basis
  • Oversee and lead subcontractors such as, but not limited to, data management, local monitors
  • If required, assist in Study audits
  • Mainline of communication between investigators/site staff and Occlutech
  • Provide regular updates to CRM on trial status, plans and bottlenecks
  • Contribute to Occlutech QM system (e.g. preparing SOPs)
  • Perform other related duties and responsibilities, on occasion, as assigned
  • Flexibility and openess to provide assistance in non-specific daily work tasks when and wherever needed

Qualifications

  • A Bachelor’s and/or a Master’s degree on science or health -related field
  • A minimum of 3 years experience in the field of clinical research
  • Knowledge of relevant government regulations, standards and guidelines
  • Knowledge on Medical Device Regulation (MDR)
  • Strong analytical and problem-solving skills & excellent interpersonal and communication skills & team player.
  • Proven track record of working in a dynamic, international environment
  • Proficient user of computer applications, software’s for the execution of daily project operations
  • Experience on using on Clinical trial management system (CTMS) or equivalent
  • Ability to travel when it is needed
  • Excellent written and spoken English.
  • Excellent written and verbal communication skills are required. Demonstrated proficiency with ICH, and GCP,ISO is required