WuXi AppTec

Study Coordinator

Job Locations US-MN-St. Paul
Job ID
2021-8839

Overview

The Study Coordinator is responsible for assisting Study Directors in the management, scheduling, and communication facilitation (internal/external) associated with nonclinical studies. Responsibilities include interfacing with the Clients/Sponsors on behalf of study directors, on non-technical items. Provides a variety of administrative support tasks across internal working groups, to assist in the planning, execution, and completion of nonclinical studies that meet Sponsor and regulatory compliance requirements. Performs task under regular direction and guidance of the immediate supervisor.

Responsibilities

  • Facilitates communication on behalf of and with Study Director/Client/Sponsor for clarifications on study folders
  • Facilitates communication amongst Study Directors on a study panel
  • Facilitates the placing of studies on hold on behalf of the Study Directors when applicable
  • Generates draft amendments when applicable after same clarification obtained for Study Director review
  • Distributes clarification or communication emails into folders as needed and on behalf of the Study Directors
  • Notifies sponsor(s) and appropriate internal personnel on Study Director’s behalf when sending amendments for signature or notification of particulates and copying all applicable Study Directors and internal personnel
  • Delivers panel study folders to prep together after initiation, facilitate clarifications as needed for after review by prep
  • Coordinate Client calls on behalf of the Study Director(s) as needed for clarification(s) or discussion purposes both before and after receipt of test article
  • Coordinates amending studies on full panels with the Study Directors
  • Assists with the completion of investigations as applicable, including deviations and non-conformances
  • Creates and organizes study files
  • 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 Procedure.
  • May be required to assist in other departments or other duties as assigned

Qualifications

Experience / Education:         

  • A Bachelor’s Degree in a related field; i.e. biology, biotechnology or life sciences is preferred with a minimum of 1 year of related work experience providing support in a scientific/technical environment that includes at least one of the following: interfacing with and handling client/customer inquiries, technical writing and/or document editing experience or application of general laboratory practices
  • In lieu of a degree, at least 3 years of related work experience is required 

Knowledge / Skills / Abilities:

  • Demonstrated ability to operate in a fast-paced, multitasking environment.
  • Demonstrated ability to manage projects of varying scope and scale project management.
  • Demonstrated organization skills and attention to detail.
  • Ability to work in a team environment and independently as required.
  • Adept at critical thinking and problem solving.
  • Proficient technical writing and document editing skills.
  • Proficient verbal & written communication skills.
  • Ability to speak, read, write and understand the English language.
  • Proficient in Microsoft (Excel, Word, Outlook)
  • Demonstrated knowledge of general laboratory procedures, aseptic technique, or GLP/GMP regulations is preferred.

Physical Requirements:

 

  • Must be able to work in an office environment with variable noise levels
  • Must not have animal allergies to applicable species in this facility
  • Clarity of Vision
  • Ability to stand /sit/walk for long periods of time
  • Must be able to perform activities with repetitive motions
  • Inside working conditions
  • Must be able to wear appropriate PPE

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

 

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.

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