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    Clincal Research Manager - Chicago, United States - Workday

    Workday
    Workday Chicago, United States

    3 weeks ago

    Default job background
    Description
    Department

    BSD CCC Network Oncology Research
    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 Network Clinical Research Manager (Manager) is a specialized research professional that is responsible for the direction of a program or a research office.

    The Manager works closely with the Director of Network Research Operations on longrange plans for network sites.

    While the Principal Investigator (PI) is primarily responsible for the overall design and conduct of the clinical trials in the network, the Manager collaborates with the PI and other senior research faculty and personnel, participates as a skilled individual contributor and/or lead researcher as an expert.

    The Manager ensures research projects progress according to plan by overseeing the coordination of the daily clinical trial activities. The Manager may write articles, reports and manuscripts and/or present research findings at meetings/conferences.

    By performing these duties, the Manager works with the PI, department, sponsor, and institution to provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.


    The job manages a team of professional staff responsible for performing clinical research including the collection, documentation, analysis of clinical trial data, and reporting of clinical research data.

    Manages the strategic, administrative, operational, and financial decisions that impact clinical research conducted across the University.
    Responsibilities

    Research Conduct/Study Management:
    Responsible for the direction of a program or research office.

    Conducts research in area of expertise.

    Collaborates with other researchers on longrange plans for research projects.

    Oversees the development of research projects.

    Ensures research projects progress according to plan.

    Investigates, modifies and applies new procedures, techniques or applications of technology.

    Establishes goals and operating procedures, practices, and guidelines.

    Establishes, monitors, and controls project budgets.


    In collaboration with senior research faculty and personnel, participates as skilled individual contributor and/or lead researcher as expert in specialized area.

    Prepares grant/funding applications.

    Manages financial, personnel, planning, compliance and other administrative aspects of research project(s).


    Data Management:
    Oversees activities related to data collection and analysis.


    Coordinates the conduct of the study from screening through to completion including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence.

    Protects patient and data confidentiality by ensuring security of research data and personal health information.


    Regulatory:
    Ensures compliance of research activities with institutional, state, and federal regulatory policies, procedures, directives and mandates.


    Understands the IRB submission and review process and when and how to apply for IRB review, including facilitation of study initiation through meticulous and timely preparation of IRB submissions.

    Understands the federal research regulations and identify the federal research organizations' role in regulating human research participation.


    Identifies and explains the responsibilities of Principal Investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.

    Writes articles, reports and manuscripts.

    Presents research findings at meetings and/or conference.


    Advises the development of a formalized training program for both new and existing staff within the unit and any affiliates and/or partners.

    Monitors federal regulatory agency requirements related to clinical research training requirements and ensures training activities comply with requirements.


    Manages PI and other senior research faculty and personnel, participates as a skilled individual contributor and/or lead researcher as expert in specialized area.

    Ensures research projects progress according to plan by overseeing the coordination of the daily clinical trial activities.

    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 7+ years of work experience in a related job discipline.
    Certifications:Preferred Qualifications


    Experience:
    Supervisory skills strongly preferred.


    Experience monitoring and auditing clinical research trials for compliance/billing accuracy (e.g., site monitoring, quality assurance, create monitoring plans) strongly preferred.

    Experience managing research projects strongly preferred.

    Experience in a leadership role strongly preferred.

    Preferred Competencies
    Ability to develop a program and a team.

    Excellent time management skills and ability to work independently.

    Ability to develop research program and work strategically with Principal Investigator(s).

    Ability to lead robust operational and financial analysis of study(ies) and/or program performance.

    Ability to read and understand clinical trials protocols.

    Knowledge of regulatory policies and procedures.

    Strong analytical skills.

    Knowledge of grant and contract administration.

    Familiarity with medical and scientific terminology.

    Demonstrated knowledge of Good Clinical Practices (GCP).

    Ability to identify funding sources strongly preferred.

    Research certification (e.g., Graham School Clinical Trials Management & Regulatory Compliance, SoCRA, ACRP) strongly preferred.

    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

    Research
    Role Impact

    People Manager
    FLSA Status

    Exempt
    Pay Frequency

    Monthly
    Scheduled

    Weekly Hours

    40
    Benefits Eligible

    Yes
    Drug Test Required

    Yes
    Health Screen Required

    Yes
    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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