Project Support Coordinator II
Job Duties: Meets all requirements of the preceding Project Coordinator levell Mentoring and train Jr PCs on Large studies Acts as a SME on study specific processe 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 Provides administrative support for effective Clinical Trial Core Team Operations Provides support with project planning & forecasting (inc plans & Project Schedule, TAQs) Provides support with reviewing and managing 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 CTMS updating 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) Vendor Mgt if no Vendor Manager Performs other duties as assigned by management to support study teams and needing collaborative support Education/Qualifications: Recommended: 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 5 years relevant industry experience. Knowledge of the clinical trial process with early clinical pharmacology experience preferred Computer competency with various programs (e.g., Microsoft Word, Excel, Project, Access and Power Point) Ability to develop accurate study related documents with minimal supervision Ability to communicate verbally and in writing Experience: Minimum Required: 2 years of relevant industry experience Additional experience may be submitted for education requirements Covance is proud to be an Equal Opportunity Employer: Covance is an equal opportunity employer and will not discriminate against any employee or applicant for employment because of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.