WuXi AppTec

  • Research Associate I

    Job Locations US-TX-Austin
    Job ID
    2018-4038
  • Overview

    Job Summary: The Research Associate I provides administrative support to clinical research projects by assisting project teams in the completion of assigned project activities. This is an in-office position with that does not require travel.

    Responsibilities

    Essential Job Functions:

    • Provides operational support for Clinical Operations
    • Under direct supervision prepares, reviews and distributes the regulatory documentation according to Essential Regulatory Document Guidelines and Trial Master File (TMF) Plan
    • Under direct supervision prepares the investigator regulatory binders and other study start-up materials, following established procedures
    • Under direct supervision designated Clinical Trial Management System (CTMS) to track and process clinical trial information, (e.g., site lists/personnel, regulatory documents, Institutional Review Board re-approvals) in order to provide analysis of information to PM
    • Prepares and provides status reports to customers with oversight from assigned PM
    • Under direct supervision assures the maintenance of the TMF
    • Under direct supervision attends clinical staff meetings, project team meetings, and clinical training sessions according to project management, and generates meeting minutes as directed
    • Under direct supervision prepares, reviews, and distributes regulatory packets, investigator regulatory binders and other study start-up materials under supervision
    • Under direct supervision performs additional administrative functions including but not limited to data entry, phone coverage, photocopying, word processing
    • Minimal quality control errors with data entry or filing
    • Timely receipt of deliverables
    • Receives supervision from line manager, project manager, or other operational staff providing leadership on operational projects
    • Must show ability to present solutions to issues; must show ability to apply previous lessons to future project work
    • Is expected to seek direction for all issues requiring a decision
    • Serve as the host for sponsor visits and audits
    • Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required
    • Ability to work in a team environment and independently as required
    • May be required to work Holidays and weekends
    • May be required to work Overtime
    • 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
    • Thorough understanding of FDA Guidelines, ICH, GCP, NDA, IND and other applicable regulations
    • Other duties as assigned
    • May be required to assist in other departments

    Qualifications

    Job Requirements

     

    Experience / Education:         

    • 1 year in office administration or equivalent with preference given to clinic or hospital environment
    • HS diploma required, Associate’s Degree preferred
    • Certification in medical transcription, office management preferred

     

    Knowledge / Skills / Abilities:

    • Must show good interpersonal communication skills in English
    • Must exhibit positive, professional demeanor in all communications
    • Basic MS Office Skills
    • Effective time management and organizational skills
    • Travel is not required

     

    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

     

    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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