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    Clinical Research Coordinator 2, Surgery - Chicago, United States - Workday

    Workday
    Workday Chicago, United States

    6 days ago

    Default job background
    Description
    Department

    BSD SUR Research Services: Clinical Research
    About the Department


    Operating since 1927 on a strong foundation of multidisciplinary clinical and academic excellence, the University of Chicago Department of Surgery's mission is to meet the most challenging and complex health problems on both a local and global scale.

    Many of our faculty members are known for their contributions to the advancement of groundbreaking surgical procedures and techniques, including minimally invasive surgery.

    In addition to our department's clinical work, our scientists pursue a diverse range of basic, translational, and clinical research projects, including studies on the gut microbiome, tissue bioengineering, stem cell research, cancer, and immunotolerance.

    This ongoing work and achievement would not be possible without the cohesive effort and commitment of the faculty and staff.

    We are looking for high energy, collaborative individuals who share our commitment to improving the health of patients in the community and beyond.

    Job Summary


    The Clinical Research Coordinator 2 (CRC2) is a specialized researcher working with the Principal Investigator (PI), Co-Investigator(s) and other study personnel, and under the direction of departmental, clinical research manager.

    With limited supervision and/or guidance, the CRC2 works with the PI, Co-Investigator(s), department, and sponsoring agencies to support and provide guidance on the administration of the compliance, financial and other related aspects of the clinical study.

    Responsibilities

    Research Conduct/Study Management:
    Manages multiple concurrent moderately complex clinical trials that may include national level and multiinstitutional pharmaceutical.

    Responsibilities include, but are not limited to, recruitment and screening of study subjects, obtaining informed consent, enrollment of subject in research study, subject followup, collecting and analyzing research data, completion of the case report form (CRF), adverse event reports and ensuring protocol adherence.


    Plans and coordinates subjects schedule for study procedures, return visits, and study treatment schedules; educates subjects about study procedures to be performed, what to report between and during visits, and the risks and benefits of the procedures; performs assessments at visits and monitors for adverse events.

    Collect, process, ship and store specimens to appropriate laboratory according to established aseptic techniques.


    Identifies adverse events and protocol deviations or violations, reports findings to PI, sponsor and IRB under general direction of clinical research manager.

    Organizes and actively participates in site visits from sponsors and other relevant study meetings.

    Maintains a safe research environment and ensures compliance with governmental and University policies, procedures and regulations.


    Data Management:
    Controls the

    acquisition/collection,

    abstraction, processing, privacy, and quality assurance for all clinical research data required for the protocol. Responsibilities include, but are not limited to, provides efficient and complete data collection, processing, analysis and reporting; assures source documentation and data abstraction and entry are being done at the protocol specified timepoints; ensures data accuracy and integrity by working closely with internal monitors and/or auditors to promptly resolve any data quality concerns or outstanding queries; and, facilitates the exchange of data across projects and organizations.


    Protect patient and data confidentiality by ensuring security of research data and protected health information (PHI) and compliance with federal regulations and sponsor protocols.

    Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, PI, and regulatory agency

    specifications.


    Regulatory Compliance:


    Works closely with Regulatory Manager to maintain accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, and study related communication.

    Ensures compliance with federal regulations and institutional policies.


    May mentor CRC1 or other CRC2 staff on the basics of clinical research, Good Clinical Practice (GCP), Good Documentation Practices (GDP), Standard Operating Procedures (SOPs) and other related aspects of the clinical study.


    Other:
    Analyzes protocols and advise treating physicians on appropriate dosage modifications or treatment calculations based on patient characteristics.

    Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.

    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
    Certifications:Preferred Qualifications


    Education:
    Bachelor's degree.

    Continuing education such as ACRP, SoCRA or the Graham School Clinical Trials Management & Regulatory Compliance certification.


    Experience:
    Experience coordinating multiple studies (e.g., investigator initiated, industry sponsored, and multisite trials).

    Preferred Competencies
    Knowledge of patient evaluation and triage procedures and the ability to monitor clinical research patients from many disciplines.

    Demonstrated ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others.

    Strong communication skills (verbal and written).

    Strong data management skills and attention to detail.

    Knowledge of medical terminology/environment.

    Excellent time management and ability to prioritize work assignments.

    Extensive knowledge of Microsoft Word, Excel and Adobe Acrobat.

    Ability to read and understand clinical trials protocols.

    Understanding of the IRB submission and review process and when and how to apply for IRB review.


    Understanding of the federal research regulations and the ability to identify the federal research organizations' role in regulating human research participation.

    Ability to absorb large amounts of information quickly.

    Application Documents
    Resume (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

    Individual Contributor
    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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