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7 days old

Project Coordinator II

Covance
Madison, Wisconsin

Job Overview

Essential Job Duties: l 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

Categories

Posted: 2019-05-15 Expires: 2019-06-14

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Project Coordinator II

Covance
Madison, Wisconsin

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