Allied Minds

  • Precision Biopsy - Senior Clinical Research Associate

    Job Locations US-CO-Aurora
    Posted Date 3 weeks ago(6/28/2018 5:02 PM)
    Job ID
    2018-1230
    Name
    Precision Biopsy Inc.
    # of Openings
    1
    Category
    Science/Lab Tech
  • Overview

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    Precision Biopsy sits squarely at the intersection of machine and molecular biology in the service of improving human health, and is backed by Allied Minds, a premier firm for commercializing early-stage technology. We create purposeful diagnostic devices that can better guide early intervention through real-time detection of suspicious tissue during biopsy exams.  More information can be found at www.precisionbiopsy.com.

     

    This position, under direction of the Manager, Clinical Operations, initiates, manages and monitors clinical trial sites involved in collecting data for clinical trials for the purpose of gaining regulatory approval or gathering additional data.

    Responsibilities

    • Assists in design of clinical protocols, proposals and Case Report Forms (CRFs) for clinical research projects.
    • Reviews scientific literature for technological applications and valid animal and/or clinical models.
    • Assists in qualification of clinical investigators and sites.
    • Organizes and participates in training of investigators.
    • Trains and monitors investigators and their staff for timely patient accrual, accurate reports and CRF completion.
    • Manages clinical sites to ensure the day-to-day study activities are in compliance and that study progress is in line with overall goals.
    • Manages Trial Master File, responsible for providing oversight to file and ensuring complete and accurate.
    • Manages overall study monitoring procedures and clinical trial monitors for all clinical sites (includes monitor training in addition to site initiation, periodic monitoring and close-out) for compliance with protocol and applicable regulations and guidelines, including adverse event and serious adverse event reporting.
    • Acts as mentor to junior staff.
    • Tracks CRF completion and submission in coordination with data entry process.
    • Ensures site receives appropriate data queries and that queries are addressed and resolved.
    • Assists with tracking budgets and processing study payments for individual studies and sites.
    • Interfaces closely with site personnel, including investigators, and also will monitor surgical procedures.
    • Acts as point of initial contact for the clinical sites for any product complaints or adverse event/serious adverse event reporting.
    • Assists sites with creating documentation for submission of protocol and informed consent to appropriate body overseeing study.
    • Obtains and maintains records and reports as required and needed for site administration and management.
    • Develops written and verbal presentations of study data for symposia, scientific presentations and exhibits, and FDA submissions, as requested.
    • Represents Precision Biopsy at professional meetings as required.

    Qualifications

    • Bachelor's degree from four-year college or university or higher level in health sciences field; three to four years related experience and/or training; or equivalent combination of education and experience. 
    • At least four years of experience as a clinical research associate, preferably in a medical device company.
    • Valid passport and ability to travel up to 75%, both domestically and internationally.
    • Good knowledge of FDA and international clinical trial regulations relating to Good Clinical Practices, including Investigational Device Exemptions (IDE), Institutional Review Boards (IRB) and Ethics Committees (EC), Sponsor and Investigator obligations as well as ISO 14155 and MEDDEV regulations.
    • Must have good to excellent computer skills, including word processing, spreadsheets, etc.
    • Must have excellent internal and external customer service skills.
    • Experience in the operating room or observing surgical cases is a must; experience with urology a plus.

    RESPONSIBILITIES TO THE QUALITY SYSTEM: 

    Be aware of the company’s quality system, including the quality policy, and understand the systems that apply to your specific work activities.  Comply with applicable quality system and regulatory requirements.  Inform responsible personnel of concerns that may affect product quality.  

     

    Precision Biopsy is committed to providing equal opportunity for all employees and applicants without regard to race, color, religion, sex, sexual preference/orientation, gender identity or expression, age, marital status, national origin, physical or mental disability, veteran status, or any other protected classification under applicable law.

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