职位描述:
* Primarily acts as back-up Medical Advisor but may serve as Regional Medical Advisor on assigned projects.
* Provides medical support to investigative sites and project staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility.
* May contribute to the medical review of the protocol, Investigative Drug Brochure (IDB) and/or Case Report Forms (CRFs).
* May provide therapeutic area/indication training for the project clinical team.
* Attends and may present at Investigator Meetings.
* Performs review and clarification of trial-related Adverse Events (AEs).
* May perform medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narrative, in collaboration with the Pharmacovigilance department.
* May provide medical support for the Analysis of Similar Events (AOSE), in collaboration with or on behalf of Pharmacovigilance department.
* May perform medical review of adverse event coding.
* Performs review of the Clinical Study Report (CSR) and patient narratives.
* Attends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
* Available 24 hours per day, 7 days per week to respond to urgent protocol-related issues at the investigative sites.