CRA – Clinical Research Associate
- Ensure clinical studies are conducted in compliance with the respective investigational plan, procedures and all applicable regulations (ICH-GCP regulations, 21 CFR).
- Support clinical sites with preparation and submission of required documentation to Institutional Review Boards. Ensure maintenance of IRB approval throughout the duration of the study, and ensures compliance with national and international regulations.
- Provide training to clinical sites regarding protocol requirements, data collection, operation of study devices etc.
- Maintain daily follow-up of study progress and conduct periodic site monitoring visits. Verify data accuracy and as part of data management performs data entry/verification.
- Provide clinical status reports in compliance with federal reporting requirements to regulatory agencies, IRBs, Investigators and senior management.
- Support in scientific and marketing publications
- Develop collaborative relationships and networking with PI’s, SSC and related subcontractors participate in the study (statistician, EDC developers)
- 5-10 years of experience in clinical trials in the medical device industry
- Strong knowledge of GCP and other regulatory requirements
- Excellent oral and written English language skills
- Overseas travel of up to 30%-40%
- Good analytical skills
- Sc. in life science or higher/medical science