• Research Regulatory Associate - Department of Radiation Oncology

    Job Locations USA-NY-New York
    Posted Date 1 month ago(9/20/2019 2:21 PM)
    Requisition ID
    2019-36676
    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

    At MSK, we’re running one of the largest clinical trials programs for cancer in the country, and at any time we are conducting hundreds of clinical trials to improve cancer care. We have a Research Regulatory Associate (RRA) opportunity in our Department of Radiation Oncology. As an integral member of the research team, you will perform all tasks associated with the regulatory management of research protocols within MSKCC. The RRA will be responsible for ensuring MSK is audit-ready at all times by maintaining up-to-date regulatory documents and regulatory files. The RRA also ensures the proper conduct of clinical research by developing, revising and maintaining accurate protocol tools at all times.

     

    You will:

    • Work closely with management to assist in all aspects of regulatory oversight for trials in the service, from start-up through study closeout, and protocols in development.
    • Partners with Clinical Research Associate to be made aware of protocol amendments and amends protocol tools as required.
    • Assist in audits- reviewing and collecting regulatory documents.
    • Maintains comprehensive, GCP/FDA compliant, regulatory files/binders for protocols. This includes, but is not limited to, collection and maintenance of the FDA Form 1572, Financial Disclosure Forms, Delegation of Authority logs, training logs, laboratory reference ranges and CLIA documentation, CVs and Licenses, Investigator Brochures, and Safety reports.
    • Participate in special projects and task forces as determined by management.
    • Utilize appropriate methodologies to collect patient/human subject information for a research project, database, and/or protocol.
    • Generate reports to all necessary parties on the progress of the research project, database, or protocol, as needed.
    • Ensure that all appropriate regulations are followed throughout the course of a research project, database, or protocol.
    • Participate or coordinate on both interdepartmental and intra-departmental organization-wide research projects as requested.
    • Provide leadership, organizational, creative, or clerical support to established and new research initiatives.

     

    You Are:

    • A good decision-maker, with proven success at making timely decisions that keep the organization moving forward.
    • Able to hold yourself and others accountable in order to achieve goals and live up to commitments.
    • Flexible in your approach and demeanor in order to align with the shifting demands of evolving circumstances.
    • Knowledgeable of the regulations pertaining to human subject protection (including 21 CFR and 45 CFR 46 of the United States Code of Federal Regulations) and Health Insurance Portability and Accountability Act (HIPAA).

     

    You Have:

    • A minimum of a High School Diploma with experience in clinical research or applicable experience.
    • A Bachelor’s degree is preferred.
    • At least 1 year of experience working in clinical research, preferably with experience in the regulatory space

     

    Hours:

    • Monday through Friday 9am-5pm, and there will be some weekend work expectations to cover potential Serious Adverse Events (SAE) reporting.

    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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