United States• Responsible for identifying problems and discussing the issues in the area of clinical data coordination.
• Resolves and/or facilitates resolution of problems including identifying causes of problems to prevent reocurrence of problems.
• Responsible for creating case report forms (CFRs), which includes tracking of all new forms and all modifications made.
• Responsible for maintaining the i...
United States• Assist with preparation for monitoring visits, such as internal regulatory file reviews and preparation, as appropriate for the assigned study.
• Maintain records of investigational devices for all assigned regulated studies.
• Facilitate the order and release of clinical IDE device inventory.
• Process invoices as needed and review payment report if applicable.
• Run IRB renewal status rep...
• Pharmacovigilance case processing: Case follow-up activities: identify information to be collected during follow-up and conduct follow-up calls and prepare written communications to obtain follow-up information. • Write case narratives and review MedWatch/CIOMS/E2B reports.
• Identify events and code with MEDRA
• Completes client notifications as required for case management.
• Aggregate re...