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Clinical Project Clerk

Company: WuXi AppTec Inc
Location: Austin
Posted on: February 16, 2020

Job Description:

OverviewJob Summary: The Clinical Project Clerk 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.ResponsibilitiesEssential 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 close supervision prepares the investigator regulatory binders and other study start-up materials, following established procedures
  • Under close 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 close 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 close 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
  • Receives supervision from line manager, project manager, or other operational staff providing leadership on operational projects
  • Is expected to seek direction for all issues requiring a decision
  • 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
      • Other duties as assigned
      • May be required to assist in other departments --QualificationsJob Requirements--Experience / Education:------------------
        • 1 year in office administration or equivalent with preference given to clinic or hospital environment
        • HS diploma required, Associates 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.--------

Keywords: WuXi AppTec Inc, Austin , Clinical Project Clerk, Healthcare , Austin, Texas

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