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    Clinical Research Regulatory Coordinator - Stanford, CA, United States - Stanford University

    Stanford University
    Stanford University Stanford, CA, United States

    3 weeks ago

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    Description
    Cancer Clinical Research Coordinator 2 – Thoracic Oncology (Hybrid)

    The Stanford Cancer Institute (SCI) is one of an elite number of National Cancer Institute-Designated Comprehensive Cancer Centers in the country, and is a prominent, dynamic, growing and complex Institute within the Stanford University School of Medicine.

    The SCI actively works to build synergies and collaborations among faculty with cancer-relevant expertise from four Schools and over 30 departments across Stanford University.

    We seek a Clinical Research Coordinator 2 to help us enact our mission to reduce cancer mortality through comprehensive programs of cancer research, treatment, education and outreach.

    Given the SCI's mission, breadth, and depth, it employs over 320 staff members in a fast-paced, team-oriented, and forward-thinking environment with tremendous opportunities for personal and professional growth.

    The Clinical Trials Office is an integral component of the Stanford Cancer Institute since the vital work performed there enables our adult and pediatric cancer centers to translate research from the laboratory into the clinical setting.

    You will be working with an unparalleled leading edge community of faculty and staff who are fundamentally changing the world of health care in the cancer arena.

    Reporting to The Thoracic Oncology Clinical Research Manager, the Clinical Research Coordinator 2 will be conversant in the goals, mission and priorities of the Institute, and utilize this knowledge to conduct industry sponsored trials, cooperative group trials, investigator initiated clinical research studies, from start up to close out.

    Our staff run toward challenges, and you will have a demonstrated history of doing the same with a high degree of professionalism, initiative and flexibility.

    Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.
    Oversee data management for research projects. Develop and manage systems to organize, collect, report, and monitor data collection. Extract, analyze, and interpret data.
    Develop project schedules, targets, measurements, and accountabilities, as assigned.

    Formally supervise, train, and/or mentor new staff or students, as assigned, potentially including hiring, preparing or assisting with the preparation of performance evaluations, and performing related duties, in addition to instruction on project work.

    Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; Provide leadership in determining, recommending, and implementing improvements to policies/processes; Develop study budget with staff and principal investigator, identifying standard of care versus study procedures.

    Track patient and study specific milestones, and invoice sponsors according to study contract.
    Ensure regulatory compliance. Regularly inspect study document to ensure ongoing regulatory compliance.
    Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Experience with oncology or hematology studies.
    Clinical research, scientific or medical experience strongly preferred.

    Bachelor's degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.

    Proficiency with Microsoft Office and database applications.

    Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.

    Knowledge of medical terminology.

    Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.

    Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.

    Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.

    *-Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.


    Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections.

    May require extended or unusual work hours based on research requirements and business needs.
    uses and promotes safe behaviors bases on training and lessons learned.

    Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, .


    Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position.

    At Stanford University, base pay represents only one aspect of the comprehensive rewards package.

    The Cardinal at Work website () provides detailed information on Stanford's extensive range of benefits and rewards offered to employees.

    Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities.

    Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources by submitting a contact form.


    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.


    The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities.



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