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    Clinical Research Manager - Chicago, United States - The University of Chicago

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    Description
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    Clinical Research Manager

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    locations

    Chicago, IL

    time type

    Full time

    posted on

    Posted 3 Days Ago

    job requisition id

    JR25057

    Department

    BSD MED Cardiology Administration
    About the Department

    The Section of Cardiology was founded in 1950 and has a proud history. We are now charting a new course that will propel us to the forefront of cardiovascular medicine.

    The strength of the Section reflects the quality and dedication of its faculty, trainees and support staff and is enhanced by the rich environment at the University of Chicago.

    Job Summary

    The Clinical Research Manager will provide project management, data management and clinical monitoring support for multiple types of trials (sponsored, grant funded, multisite, and/or

    investigatorinitiated

    trials) in the Section of Cardiology in the Department of Medicine.

    Responsibilities

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

    Conduct research in area of expertise.

    Collaborate with other researchers on longrange plans for research projects.

    Oversee the development of research projects.

    Ensure research projects progress according to plan.

    Investigate, modify and apply new procedures, techniques or applications of technology.

    Establish goals and operating procedures, practices, and guidelines.

    Establish, monitor, and control project budgets.

    In collaboration with research faculty and personnel, participate as skilled individual contributor and/or researcher.

    Prepare grant/funding applications.

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


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


    Coordinate 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.

    Protect patients and data confidentiality by ensuring security of research data and personal health information.


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


    Understand 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.

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


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


    Supervision:
    Supervise both researchers and research support staff.


    Plans and manages the protocol review process for all clinical trials which includes the receipt and coordination of protocols for review, committee meetings, and clinical research conferences.


    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.

    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

    Education:
    Master's degree.


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

    Supervisory skills.

    Working knowledge of managing research projects.

    Background in a leadership role.

    Licenses and

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

    Preferred Competencies
    Develop a program and a team.

    Excellent time management skills and ability to work independently.

    Develop research program and work strategically with Principal Investigator(s).

    Lead robust operational and financial analysis of study(ies) and/or program performance.

    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).

    Identify funding sources.

    Application Documents
    Resume/CV (required)

    Cover Letter (required)

    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

    37.5
    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 60637.
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