WuXi AppTec

  • Clinical Research Associate II - Future Projects

    Job Locations US-TX-Austin
    Job ID
    2018-3896
  • Overview

    The Clinical Research Associate Performs and coordinates aspects of the field-based and office-based monitoring and data quality control functions in accordance with Good Clinical Practices (GCP), International Conference on Harmonisation (ICH), and ResearchPoint Global SOPs. This can be a work from home position and requires approximately 50-75% travel.  

    Responsibilities

    Essential Job Functions:

    • Provides operational support for Clinical Operations
    • Performs field-based and in-house monitoring and site management tasks to assure conformance to current regulatory, ResearchPoint Global, and sponsor requirements
    • Performs data quality control functions including, but not limited to, query management and data audit functions
    • Participates in team and sponsor meetings and training programs, as required
    • Produces and maintains documentation of activities and findings as required by ResearchPoint Global and sponsor
    • Perform other project-related duties as specified by project manager or supervisor including, but not limited to mentoring of CRA I and other junior personnel
    • Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
    • Normally receives minimal instructions on routine work and detailed instructions on new assignments.
    • Works under close supervision from supervisor or senior personnel.
    • 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.
    • 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

    Experience / Education: 

    • 2 years of relevant experience or equivalent
    • Bachelor’s Degree or equivalent experience
    • Oncology/Critical Care experience preferred

     

    Knowledge / Skills / Abilities: 

    • Proficient skills with Microsoft Office Suite applications
    • Must have strong attention to detail and demonstrate understanding of the critical nature of ResearchPoint Global documentation 
    • Must have ability to initiate steps according to established processes without intervention
    • Must have ability to interact with internal and external customers and sites professionally, using clear diction
    • Must be able to solve problems independently when required and must be able to anticipate risks to the project within the scope of the position and to propose solutions to supervisor
    • Must have positive, professional demeanor with all interactions on the phone or in the office
    • Must have excellent verbal and written communication in English
    • Ability to work in team environment and effectively manage multiple priorities within established time constraints 
    • Expected to have knowledge of Good Clinical Practices; good working knowledge of physician care in hospitals, clinics, or other healthcare settings.  Ability to work in satellite environment independently, but remain engaged with home office and supervisor
    • Ability to mentor staff
    • If working remotely, must have access to high speed internet and knowledge/ability to resolve IT and computer related challenges through remote communication challenges
    • Travel is required 50-75% , primarily domestic/infrequently international, daily/overnight
    • Must have a valid driver’s license and the ability to rent a car

     

    Physical Requirements:         

    • Must be able to work in an office or medical site
    • Ability to stand or sit for some work days and travel other days
    • Must be able to perform some activities with repetitive motion, such as keyboarding
    • Must be able to travel for long distances in various methods of transportation (e.g. car, airplane, shuttle bus, train, etc.)
    • Must be able to navigate to and from site locations, hotel, and airports with personal luggage and laptop

     

    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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