OMNI Human Resource Management

  • Regulatory Assistant

    Job ID
    2018-2167
    Client
    Vince & Associates Clinical Research
    Job Location(s)
    US-KS-Overland Park
  • Overview

    Altasciences- Vince and Asso

    Do you want a fast-paced, exciting and innovative career in research? Altasciences is hiring a full-time Regulatory Assistant for their Overland Park campus.

     

    Altasciences Clinical Research, encompassing Algorithme Pharma, Vince & Associates Clinical Research and Algorithme Pharma USA, is one of the largest early phase clinical research organizations (CROs) in North America. As a leading, full-service CRO, we have extensive expertise in the execution of a wide range of Phase I/II clinical studies, especially complex trials in healthy normal volunteers and patient populations.

     

    The Regulatory Assistant performs general administrative research duties to assist with start-up and maintenance activities for VACR Clinical studies. This position must have the ability to work on multiple tasks and projects at any given time and will report to the Director, Clinical Project Management.

     

    DP-IND

    Responsibilities

    • Process and track new and existing investigator certifications and/or licenses to allow participation on research studies, keeping Investigator CVs up to date with all study information and training.
    • Create and maintain Delegation of Authority logs as well as all protocol specific training documentation for all clinical studies.
    • Facilitate the execution of required regulatory documents such as obtaining signatures
    • Maintain internal electronic databases and paper logs, tracking and organizing study documents 
    • Set up and maintain paper-based and electronic study files
    • Perform other related activities as assigned

    Qualifications

    • High School Diploma or GED, and a College Degree preferred
    • Minimum 1 year of  regulatory experience preferred
    • Excellent organization skills and acute attention to detail
    • Ability to communicate effectively both verbally and in writing  
    • Demonstrated ability to work independently

     

     

     

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