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    Regulatory Manager - Chicago, United States - Workday

    Workday
    Workday Chicago, United States

    2 weeks ago

    Default job background
    Description
    Department

    BSD CCC Clinical Trials Office
    About the Department

    The University of Chicago Comprehensive Cancer Center (UCCCC) is an integral component of the Biological Sciences Division (BSD). The BSD is the largest of four Divisions of the University and includes the Pritzker School of Medicine. UCCCC administers four established scientific programs, and the NCIsponsored Cancer Center Support Grant provides funding for ten Shared Resources. The Comprehensive Cancer Center is comprised of over 150 faculty members from twenty departments with members currently being awarded over $47 million in total direct costs in peerreviewed cancer research grants, and $28 million in nonpeer reviewed grants and contracts.

    The activities of the Center are broad and varied, including research, training and education, communications, fundraising, marketing, clinical trials management and community outreach.


    UCCCC has one of the largest cancer clinical trials programs in the country and in the Chicago area with nearly 500 adult and pediatric therapeutic trials actively accruing patients.

    Many of these studies are investigatorinitiated, including Phase I or I/II trials, demonstrating UCCCC commitment to translate basic research findings to the clinic through proofofprinciple and early phase studies. UCCCC opens over 250 new trials each year and accrues approximately 900 participants to therapeutic trials each year.
    Job Summary


    The job maintains regulatory compliance programs, including the interpretation of systems to identify areas of risk and may coordinate internal audits.

    With a moderate level of direction, participates in compliance documentation, compliance training, and compliance committee formation.

    This atwill position is wholly or partially funded by contractual grant funding which is renewed under provisions set by the grantor of the contract. Employment will be contingent upon the continued receipt of these grant funds and satisfactory job performance.
    Responsibilities
    Responsible for study start up activities and regulatory maintenance of assigned portfolio of clinical research studies.

    Creation and maintenance of study regulatory files in study binders, shared drives, and/or eRegulatory product.

    Prepares regulatory files for monitoring and auditing activities and addresses outstanding issues resulting from routine monitoring activities.

    Provides guidance to PIs, research team, auditors, and other affiliated staff related to the maintenance of regulatory compliance.

    Participates in working groups and/or other internal committees as assigned.

    Completes internal trainings as required.

    Coordinates department or clinic compliance with a moderate level of

    guidance.

    Prepares,

    completes

    and

    submits

    all

    compliance

    documentation

    on

    a

    routine

    basis.

    Coordinates

    compliance committee

    meetings.

    Performs other related work as

    needed.

    Minimum Qualifications


    Education:
    Minimum requirements include a college or university degree in related field.
    Work

    Experience:
    Minimum requirements include knowledge and skills developed through 25 years of work experience in a related job discipline.
    Certifications:Preferred Qualifications


    Experience:
    4+ years of prior work experience in clinical research regulatory compliance.

    Advanced degree or certification in clinical research or related field.

    Clinical research certification (SOCRA, ACRP, etc.).

    Demonstrated familiarity with federal and international regulations governing the oversight and conduct of clinical research.

    Strong oral and written communication skills with both teams, faculty, and external vendors and sponsors.

    Project management experience.

    Preferred Competencies
    Performs assigned tasks independently.


    Responsible for understanding and interpreting the Code of Federal Regulations, Institutional Review Board policies and procedures as well as other regulatory policies regarding human subject research.


    Completion of human subjects and Good Clinical Practice trainings within 30 days of hire and maintaining compliance with training requirements (refresher training every 3 years).

    Completion of clinical research certification (SOCRA, ACRP, etc.) within 2 years of hire (must maintain certification).

    Working Conditions
    Hybrid work arrangements will be considered.

    Application Documents
    Resume (required)

    Cover letter (preferred)

    When applying, the document(s)


    MUST
    be uploaded via the

    My Experience

    page, in the section titled

    Application Documents

    of the application.

    Job Family

    Legal & Regulatory Affairs
    Role Impact

    Individual Contributor
    FLSA Status

    Exempt
    Pay Frequency

    Monthly
    Scheduled

    Weekly Hours

    40
    Benefits Eligible

    Yes
    Drug Test Required

    No
    Health Screen Required

    No
    Motor Vehicle Record Inquiry Required

    No
    Posting Statement

    The University of Chicago is an

    Affirmative Action/Equal Opportunity/Disabled/Veterans


    and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, national or ethnic origin, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law.

    For additional information please see the

    University's Notice of Nondiscrimination.

    Staff Job seekers in need of a reasonable accommodation to complete the application process should call

    or submit a request via

    Applicant Inquiry Form.


    We seek a diverse pool of applicants who wish to join an academic community that places the highest value on rigorous inquiry and encourages a diversity of perspectives, experiences, groups of individuals, and ideas to inform and stimulate intellectual challenge, engagement, and exchange.

    All offers of employment are contingent upon a background check that includes a review of conviction history.

    A conviction does not automatically preclude University employment.

    Rather, the University considers conviction information on a casebycase basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position.


    The University of Chicago's Annual Security & Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information.


    The Report can be accessed online at:
    . Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL

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