• Field Clinical Monitor

    Job Locations US-MA-Bedford
    Posted Date 3 weeks ago(3 weeks ago)
    Job ID
    2018-1106
    # of Openings
    1
    Category
    Operations
  • Overview

    Responsibility for verifying that the rights and well-being of human subjects are protected and that the reported trial data are accurate, complete, and verifiable from source documents.  Ensure the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirements.  Participate in clinical research programs by assisting with the development of study protocols, case report forms, clinical reports; and interfaces with site coordinators, investigators, Clinical Research Organizations (CRO), and other company representatives. 

    Responsibilities

    • Verify that all research staff and facilities have adequate qualifications and resources, and these remain adequate throughout the trial
    • Verify that the investigator follows the approved protocol and all GCP procedures
    • Verify that source data/documents and other trial records are accurate, complete, and maintained
    • Communicate deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the Investigator
    • Ensure that documentation from investigators and investigational sites meets FDA/GCP/ICH requirements
    • Review study records including case report forms, consent forms, and other materials
    • Assist site coordinators and investigators in collecting data in a timely manner that meets the protocol requirements
    • Serve as a resource to site coordinators, investigators, and other staff members regarding investigational products and protocols
    • Perform other clinical duties when requested

    Qualifications

    • BA/BS
    • Knowledge of applicable regulatory guidelines
    • Three to five years of clinical affairs experience in the pharmaceutical or medical device industry with a minimum of 2 years monitoring experience with pharmaceutical or medical device trials
    • Excellent professional written and oral communication skills
    • Computer literacy, proficiency in MS Office, Excel, PowerPoint, etc.
    • Excellent organizational skills and attention to detail
    • Physical location near a major US airport; ability to travel up to 70%

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