• Regulatory Research Study Assistant (Montvale, NJ)

    Job Locations USA-NJ-Montvale
    Posted Date 1 week ago(7/13/2018 3:21 PM)
    Requisition ID
    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

    Regulatory Research Study Assistant- NCI Network, Clinical Research Administration

    As an integral member of the team responsible for overseeing conduct on our NCI-sponsored, NCTN and NCI consortium clinical trials and in compliance with all regulatory, institutional, and departmental requirements, the Regulatory Research Study Assistant provides regulatory support across the portfolio (~200 trials).  Responsible for regulatory, and integrity checks at the service specific level. Participates in special projects and partners closely with IRB, SAE, FDA and QA teams as determined by management.


    You will:

    • Assist regulatory processes across the portfolio
    • Prepares for cooperative group and NCI audits
    • Participates in special projects and regularly interfaces with MSK regulatory teams (IRB, IND, SAE, etc) as determined by management.
    • Utilizes appropriate methodologies to collect patient/human subject information for a research project, database, and/or protocol
    • Assists with generation of reports on the progress of the research project, database, or protocol, as needed
    • Assists in managing departmental data and portfolio metrics. Communicates with staff at all levels (principal investigators, clinical and research support staff).
    • Assists in the review and maintenance of regulatory binders/documents
    • Ensures that all appropriate Institutional, State, and Federal regulations are followed throughout the course of a research project, database, or protocol. Ensures that research protocols are approved by the Institutional Review Board and followed as written
    • Participates in study transitions to long term follow up team
    • Ensures that workflows across the CRA are controlled and meet departmental needs
    • Participates or coordinates on both interdepartmental and intradepartmental organization-wide research projects as requested
    • Provides organizational, creative, or clerical support to established and new research initiatives


    You need:

    • A minimum of a High School Diploma and 2 years of relevant experience
    • Must be able to work independently, be flexible, and meet tight deadlines
    • Experience in research and/or other applicable research investigation
    • Microsoft applications, database knowledge a plus

    You are:

    • Action-oriented and eager to embrace new opportunities and tough challenges with a sense of urgency, high energy, and enthusiasm
    • Able to work effectively in an environment notable for complex, sometimes contradictory information
    • Adept at building partnerships and working collaboratively with others to meet shared objectives and goals





    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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