• Human Research Protection Program Operations Coordinator

    Job Locations USA-NY-New York
    Posted Date 2 months ago(2/11/2019 1:28 PM)
    Requisition ID
    2018-27372
    Category
    Research - Clinical
  • Company Overview

    At Memorial Sloan Kettering (MSK), we’re not only changing the way we treat cancer, but also the way the world thinks about it. By working together and pushing forward with innovation and discovery, we’re driving excellence and improving outcomes.
     
    For the 28th year, MSK has been named a top hospital for cancer by U.S. News & World Report. We are proud to be on Becker’s Healthcare list as one of the 150 Great Places to Work in Healthcare in 2018, as well as one of Glassdoor’s Employees’ Choice Best Place to Work for 2018. We’re treating cancer, one patient at a time. Join us and make a difference every day.

    Job Description

    Human Research Protection Program (HRPP)

     

    Are you committed to human research protection for patients involved in clinical trials? Are you passionate about working in clinical trials, but looking to get more exposure to the back-end?

     

    In the HRPP, we are responsible for protecting the rights and welfare of human research participants in accordance with the federal regulations and internal standard operating procedures. Our team is service based and provides continuing education and guidance to investigators and research staff. We are seeking a Coordinator to support our collaborative team. In this role, you will provides operational, technical, administrative assistance and expertise to ensure the rights and welfare of research participants are protected.

    You Will:

    • Process and review Serious Adverse Events (SAE) submissions
    • Identify and analyze trends by running reports on SAEs
    • Review and reconcile MSK sponsored trials IND annual reports for accuracy of SAE reporting
    • Work closely with research teams and investigators to ensure that SAEs, Unanticipated problems, OSRs, and Safety Notifications, etc, are reported according to institutional SOPs and federal regulations
    • Serve as a liaison research staff for human subjects protections and regulatory compliance providing guidance and troubleshooting issues
    • Participate in special projects assigned by the HRPP Operations Manager, HRPP Operations Administrator, IRB Administrators and/or HRPP Director.

    You Are:

    • An individual who takes a broad view and applies it when approaching issues.
    • Adept at learning quickly, applying insights from past efforts to new situations.
    • Able to work independently, using judgement to escalate to leadership

    You Have:

    • A Bachelor’s degree (strongly preferred) and at least 1 year of experience in clinical research and/or regulatory.
    • Knowledge of State and Federal HHS regulations regarding human subjects protection (45 CFR 46), the HIPAA Privacy Rule (45CFR 160,164), the FDA (21 CFR 50, 21 CFR 56).

    Closing

    MSK is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sexual orientation, national origin, age, religion, creed, disability, veteran status or any other factor which cannot lawfully be used as a basis for an employment decision.  

     

    Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.

     

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