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

    University of Chicago
    University of Chicago Chicago, United States

    1 week ago

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    Description
    Department

    BSD MED - Pulmonary - Administration

    About the Department


    The Section of Pulmonary and Critical Care Medicine has been a model of exemplary patient care, research, and post-doctoral training for more than 20 years.

    The 30 faculty, clinical associates and research associates along with a staff of more than 72, have devoted themselves to the pursuit of excellence in each of these important activities.

    Job Summary


    The Clinical Research Manager is a specialized research professional that is responsible for the direction clinical research activity within the Section of Pulmonary/Critical Care in the Department of Medicine.

    Responsibilities


    • 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 research faculty and personnel, participates as a skilled individual contributor and/or researcher.
    • Prepares grant/funding applications in collaboration with pre-award office.
    • Manages financial activities and works closely with post-award office to obtain financial reports.
    • Analyze and summarize, as well as distribute financial reports for respective PI(s) on quarterly basis.
    • Manages financial, personnel, planning, compliance and other administrative aspects of research project(s); ensure enough funding to support any proposed, new positions before initiating job posting approvals/requests for posting.
    • 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.
    • 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 identifies the federal research organizations' role in regulating human research participation.
    • Identifies and explains responsibilities of Principal Investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.
    • Supervises both researchers and research support staff.
    • Works collaboratively with PI(s) to provide guidance on potential clinical trials and have full understanding on the resource needs of the projects (i.e. personnel, lab supplies, patient payment for study participation, if applicable, etc.).
    • 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, creating monitoring plans).
    • Experience with site visits to maintain site certification based on foundation guidelines (Cystic Fibrosis Foundation, Pulmonary Fibrosis Foundation, etc.).
    • 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 and 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 case-by-case 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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