WuXi AppTec

  • Project Specialist I

    Job Locations US-TX-Austin
    Job ID
  • Overview

    Job Summary: The Project Specialist I supports project managers to ensure the contracted services and expectations of clinical studies are carried out by project teams in accordance with the executed contracts and the customer expectations. This is in-office position with <10% travel required.


    Essential Job Functions:

    • Provides operational support for Clinical Operations
    • Establishes tracking procedures for projects under minimal direction of manager; maintains and updates project tracking tools, metrics, and computer databases, and meeting minutes as required
    • Conducts secondary review of essential regulatory documents
    • May serve as project representative for internal and external TMF audits

    May serve as primary site contact for collection of regulatory documents, tracking and maintaining drug/study supplies, and administrative study related questions

    • Provides indirect management and direct training of Research Associates
    • Performs quality reviews under the direction of the project manager as required including, but not limited to, review of trial and site study files
    • Assists with communication and leadership within the Clinical Operations team and may serve as designated point person in absence of Manager, Clinical Administration and/or Project Manager
    • Performs training within the company
    • High-quality and timely deliverables, and minimal quality errors
    • Position has no direct budget responsibilities, but inadequate quality of work may result in missed deadlines including contract bonuses and penalties
    • Gives indirect management/guidance to RAIs and RAIIs and direct training on project-specific tasks
    • Receives supervision from Manager, Clinical Administration, Project Specialist II, Project Manager, or other operational staff providing leadership on operational projects
    • Ability to work in a team environment and independently as required
    • Contributes to the overall operations and to the achievement of departmental goals
    • Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures
    • Demonstrates flexible and efficient time management, ability to prioritize workload, exercise good judgment in a variety of situations and work under pressure at times to handle a wide variety of activities and confidential matters with discretion


    Job Requirements


    Experience / Education:          

    •  Minimum of 3 years in clinical research environment managing administrative aspects of clinical trials or equivalent experience; previous supervisory experience and company experience preferred
    • High School diploma or associate’s degree required
    • Bachelor’s degree preferred


    Knowledge / Skills / Abilities: 

    • Demonstrates problem solving ability, taking into consideration time, quality, and customer relations
    • Independently extrapolates and applies decisions from previous discussions to new situations and recognizes the relevance from one situation to the next
    • Requires only minimal supervision on decisions that could have substantial impact on clinical administration issues
    • Must show ability to review regulatory documents in advance of quality assurance review with high level of accuracy and make decisions on the quality of the documents and take appropriate action
    • Requires good oral and written communication skills to interact with other members of project team and to build rapport with sites and others as needed
    • Ability to effectively communicate issues and potential resolutions to sites, CRAs, and manager
    • Must show excellent interpersonal communication skills and exhibit ability to build rapport with team members
    • Ability to teach and effectively communicate to other clinical administration staff
    • Must exhibit good technical writing skills in English with minimal grammatical or logical errors
    • Exceptional communication and professional rapport with internal and external customers, setting the example for others and mentoring team members as needed
    • Intermediate to advanced skills with Microsoft Office Suite applications
    • Must have strong attention to detail and demonstrate understanding of the critical nature of RPG documentation
    • Must have ability to initiate steps according to established processes without intervention
    • Must have ability to interact with internal and external customers professionally, using clear diction
    • Must be able to solve problems independently and must be able to anticipate risks to the project within the scope of the position and to propose solutions
    • Must have positive, professional demeanor with all interactions on the phone or in the office
    • Ability to organize workload and handle multiple priorities, as well as manage and train other Clinical Administration staff on best practices and how to manage their time and schedules
    • Ability to work in team environment
    • Must have high level of adaptability as task requirement and priorities change quickly


    Physical Requirements:                   

    • Must be able to work in an office environment, which has minimal noise conditions
    • Ability to stand or sit for most of the work day
    • Must be able to perform some activities with repetitive motion, such as keyboarding
    • <10% travel required


    This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.  Employees holding this position will be required to perform any other job-related duties as requested by Management.


    An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.



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