The CRA is responsible for assisting in managing and meeting the objectives of ZOLL Clinical Programs. The duties will be to support the daily in-house activities of the various clinical trials as well as case support/coverage in the field in instances where the clinical specialists are already booked.
Site Management including review of monitoring reports, review of site contracts, assist sites with IRB/EC submissions, completion of site checklist, collection and review of regulatory documents, site payments creation, tracking and management, investigational device disposition and tracking, study supplies ordering and replacement, updating of serious adverse events reports in collaboration with the Safety team for US and OUS reporting requirements. The CRA will be responsible for helping organize and track communications and study regulatory documents consistent with Good Clinical Practice (GCP), ICH Guidelines, CRF 21 and company’ Standard Operating Procedures (SOPs). Planning and organization of investigators meetings and research coordinators meetings. Provide sites protocol and device training remotely or in person as needed.