Essential Job Duties:
Project expertise for CTMS reporting, study metrics, risk management regarding communication, coordination, and eTMF quality.
Able to co-ordinate and manage support across large global study
Applies therapeutic knowledge to daily activities of the clinical trial, brings new knowledge to the team, drives best practices in coordination, communication and documentation
Primary responsibility for the coordination and completion of all administrative functions in support of the project manager.
Job duties include:
Provides administrative support for effective Clinical Trial Core Team Operations
Provides support with assisting with all aspects of project (financials, enrollment, vendors, etc).
Attend and coordinate study meetings internal, sponsor, (including KOM, IM, as needed, working with Scarrit as needed).
Develop Protocol Tools, Coordinate study plans and development and support management of study plans, guidelines, utilized MS Project for timelines with the ICRA
Develop Inv Training
Regulatory/Pharmacy Binders and study materials.
Create and revise Project Specific Forms
Payments for manually tracked (AsiaPac)
ADI logs and Agenda/minutes/Slide decks
Manage and maintain Sponsor system portals
Provides Site and team communications
Drafts and formats Newsletters
Assist with coordinating Audits (assist in response to internal audits and CAPA resolutions)
Follow up on Governace portal issues
Trackers (including financial and vendors)
Performs other duties as assigned by management to support study teams and needing collaborative support
University/college degree, or certification in a related allied health profession (i.e. nursing, medical or laboratory technology), in lieu of college degree candidate may have relevant industry experience.
0-2 years of relevant industry experience.
Additional experience may be substituted for education requirements.