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Company: MedStar Medical Group
Location: Washington, DC
Career Level: Entry Level
Industries: Not specified

Description

General Summary of Position
Implements and coordinates research and administrative procedures for the successful management of clinical trials. Performs diverse administrative duties requiring analysis, sound judgment and a high level of knowledge of study specific protocols. Enters study and/or research participant data into the Clinical Trial Management System (CTMS) as applicable.


Primary Duties and Responsibilities

  • Regulatory responsibilities include the oversight and/or responsibility for the Intuitional Review Board (IRB) submissions, and other related regulatory forms (e.g., scientific review), and adhering to the timelines of the study start-up process; developing informed consent documents and other documents as applicable; supporting the safety of clinical research participants; ensureing the appropriate delegation of study related tasks (i.e., Delegation of Authority).
  • Explains the informed consent process and the study to the research participant (e.g., purpose, duration, risks/benefits) and obtains all required signatures; ensures the research participant has sufficient time and opportunity to ask the investigator medical questions; documents the informed consent process in the source document and provides the research participant with a copy of the informed consent.
  • Develops an effective recruitment plan (e.g., central recruitment core); recruits research participants and discuss study protocol; educates research participants about protocol expectations and meets with research participants for each visit and maintains accessibility to discuss any questions or concerns regarding the study;
  • Oversees the development of advertising materials; participates in teleconferences and/or meetings to review study progress and conduct.
  • Data entry responsibilities include the completion and maintenance of case report forms and reviews data against the research participant's medical record for completeness and accuracy; addressing all queries, clarifications and outstanding data queries and appropriately communicating with the sponsor and/or Contract Research Organization (CRO); completing and submitting case report forms on as close to a real time basis" as possible.
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    Minimum Qualifications
    Education

    • Bachelor's degree or an allied health or related professional degree required, or equivalent work experience

    Experience

    • 2 years of relevant clinical research experience required
    • Experience in a healthcare setting preferred
    • Undergraduate and/or work experiences that demonstrates aptitude for research facilitation preferred

    Knowledge, Skills, and Abilities

    • Verbal and written communication skills.
    • Basic computer skills preferred.


    This position has a hiring range of $58,656 - $98,384

     


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