OMNI Human Resource Management

  • Lab Source Specialist

    Job ID
    2018-2263
    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? Vince and Associates Clinical Research is currently looking for a Lab Source Specialist for their Overland Park, KS campus.

     

    Altasciences Clinical Research, encompassing Algorithme Pharma, Vince and 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 Source Document Specialist’s primary responsibilities are to accurately design, modify and create source documents used in the clinic during procedures to collect data in accordance with protocols. The Source Document Specialist coordinates with the clinical project team and study support team to ensure all aspects of source creation are accurately represented across all departments and systems.

    Responsibilities

    • Design source documents based off information extracted from protocol and perform self-review to ensure accurate reflection of protocol and laboratory manual requirements.
    • Creation and maintenance of complex spread sheets for daily source creation.
    • Update and maintain version changes to source documents throughout the study ensuring proper communication to applicable parties.
    • Update and maintain general source templates.
    • Review and provide feedback on draft study schedules to Study Support department.
    • Gather operational information from Project Managers, taking notes and writing complex instructions.
    • Proper communication with Clinical Project Team, Study Support, Quality Control and Laboratory Source Document Specialists.
    • Keep apprised of applicable SOP’s and general clinical trial knowledge in order to extract all needed information to facilitate creating source documents.
    • Maintain knowledge of blood collection, ECG and vital sign operations, BMI calculations, and other applicable procedures.
    • Manage time in a manner that allows for complete review of final documents and amendments for multiple trials simultaneously.
    • Maintains knowledge of GCP, GLP, HIPAA, WHO guidelines and FDA rules and regulations.
    •  Manage related work instruction storage, revisions, and creation.

    Qualifications

    • High School Diploma or GED is required and a College Degree in the medical field or science field is required or equivalent job experience.
    • 1 to 2 years experience in a clinical trial setting
    • Experience in electronic data capture in clinical trials databases
    • Intermediate proficiency in Microsoft Office (Excel and Word specifically)
    • Technical problem solving and critical thinking skills
    • Ability to understand and follow standard operating procedures and protocol
    • Ability to multitask in fast- paced work environment.
    • Strong attention to detail

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, and protected veteran status, or disability status.

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