Location: US – Irvine, CA or Remote in the US
Job Type: Full time
- Support study sites and activities to ensure adherence to appropriate industry US and OUS regulations, compliance with the study Protocol(s), and applicable local regulations
- Assist in coordination of study tasks from start-up phase through study completion
- Maintain internal Trial Master Files (TMFs) and prepare study TMF for audit readiness
- Assist in organizing Steering Committee events and meetings
- Prepare dashboards, reports and other internal tracking mechanisms
- Work with the CRO and Core Labs to ensure study operations and activities are of a high quality
- Assist with organization and preparation for Investigator meetings and Study Coordinator meetings
- Ensure proper escalation of site/project related issues to the Study Lead in a timely manner
- Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff
- Assist with device accountability
- Support internal audit preparation
- Collect and file site study documentation (e.g. ICFs, CTAs, budgets)
- At least 1-2 years of experience working in the medical device space in a CRO or Sponsor setting with strong knowledge of conducting studies under ICH and GCP guidelines
- Plus, but not required: Experience working on an IDE clinical study
- Plus, but not required: Experience with peripheral clinical studies
- Required: A minimum of a Bachelor’s degree.
- Attention to detail and accuracy of output
- Ability to communicate efficiently and effectively with investigators, site research staff and co-workers
- High energy – Enjoys and has a track record of operating independently
- Skill in prioritizing workflow to meet deadlines
- Capable of working across multiple time zones including Europe
- Fluent in English