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    Research Quality Improvement - Baltimore, United States - University of Maryland, Batlimore

    University of Maryland, Batlimore
    University of Maryland, Batlimore Baltimore, United States

    8 hours ago

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    Description

    The Quality Assurance and Compliance Office within the Clinical Research Management Office (CRMO) of the University of Maryland, Baltimore School of Medicine, Marlene and Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) is currently recruiting for a full-time Research QI & Compliance Analyst.

    Following an extensive training program, the Research QI & Compliance Analyst will serve as an on-site monitor for a portfolio of Cooperative Group (e.g., NCI Alliance) studies, as well as Investigator Initiated Trials currently being conducted at UMGCCC as well as affiliate sites within the UMGCCC Network.

    The Research QI & Compliance Analyst will be responsible for conducting and reporting of monitoring activities to various study teams within the CRMO.

    The Research QI & Compliance Analyst will also be responsible for preparations for upcoming audits and inspections.

    The Research QI & Compliance Analyst will interface directly with the Principal investigators on UMGCCC protocols as well as the research team within UMGCCC and sponsor representatives external to UMGCCC.

    This position allows for a hybrid work environment.

    UMB offers a comprehensive benefits package that prioritizes wellness, work/life balance, and professional development.

    Exempt regular staff receive a generous leave package that includes over 4 weeks of vacation accrued each year, paid holidays, unlimited accrual of sick time, and comprehensive health insurance and retirement options; professional learning and development programs; tuition remission for employees and their dependents at any University System of Maryland school; and flexible work schedules and teleworking options (if applicable per job).

    Essential Functions


    • Responsible for collecting, tracking, and analyzing data pertaining to regulatory documentation.
    • Maintains up-to-date department information including faculty medical licenses, CVs, lab certifications, staff training certifications, etc. necessary to maintain compliance with study protocols. Coordinates and maintains data reports and database files on progress of research studies.
    • Receives, inventories, enters, and organizes collected data and regulatory documents.
    • Prepares and presents regulatory reports for presentation or submittal to sponsoring agent, Principal Investigators, and staff.
    • Prepares and responds to audits conducted by study sponsors.
    • Assists in the preparation of initial and ongoing IRB submissions and proposals and maintains regulatory files for all research studies.
    • Determines reliability of data sources by evaluating information, determining errors, and notifying responsible parties.
    • Performs other duties as assigned.

    Education:
    Bachelors in nursing, life science, healthcare administration, public health, policy, law or related field of the research.

    Experience:
    One (1) year of experience in a clinical and/or laboratory research or related experience involving regulatory compliance issues.

    Other:

    Except for qualifications established by law, additional related experience and formal education in which one has gained the knowledge, skills, and abilities required for full performance of the work of the job class may be substituted for the education or experience requirement on a year-for-year basis with 30 undergraduate college credits being equivalent to one year of related experience.

    In instances where specific education and/or experience is required only directly related education and/or experience may be substituted.


    Knowledge, Skills, and Abilities:
    Knowledge of position requirements. Knowledge of all applicable requirements, regulations, and laws. Skill in effective use of applicable technology/systems. Ability to effectively communicate both verbal and written thoughts, ideas, and facts. Ability to work cooperatively with others and independently.

    Ability to demonstrate, understand, apply, and adhere to the UMB Core Values of Respect and Integrity, Well-being and Sustainability, Equity and Justice, and Innovation and Discovery.

    Hiring Range for this position is in the low to mid $50,000s, commensurate with education and experience.

    UMB is an Equal Opportunity/Affirmative Action Employer.

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

    For assistance related to employment, please contact the Staffing department at


    If you anticipate needing a reasonable accommodation for a disability under the Americans With Disabilities Act (ADA), during any part of the employment process, please submit a UMB Job Applicant Accommodation Request.

    You may also contact Please note that only inquiries concerning an ADA request for reasonable accommodation will be responded to from this email address.

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