• Project Coordinator I

    Job Location(s) US-NC-Raleigh-Durham | US-WI-Madison
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  • Job Overview

    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

    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)

    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.

    • 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


    Minimum Required:

    0-2 years of relevant industry experience.                                                                                                                                                                  


    Additional experience may be substituted for education requirements.


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