• Manager Clinical Research-Emergency Medicine

    Job Locations US-IL-Chicago
    Posted Date 2 months ago(9/25/2018 9:54 AM)
    Requisition ID
    2018-6989
    Category
    Research
    Position Type
    Regular Full-Time
    Shift
    Days
  • Overview

    The Clinical Research Manager in the Division of Emergency Medicine provides leadership, strategic management, and administration for the clinical and translational research program of the Emergency Medicine Division. Supervises, manages and professionally develops the clinical research staff (e.g., clinical research coordinators) in the Emergency Medicine Division. Serves as the key operational interface between the funding agencies, research center, research team and principal investigators. Develops, implements and manages research and organizational processes. Oversees implementation of research plans, and dissemination and application of findings in conjunction with the Director of Research and principal investigators. This position will be responsible for the management and oversight of pre-award and post-award activities relating to sponsored research studies for the Division in conjunction with Office of Sponsored Programs. This includes preparing research budgets, contract negotiations and post award management. This position will also perform functions of a clinical research coordinator for a proportion of divisional studies. Works with a multidisciplinary team of physicians and staff to maintain an environment that encourages customer service and promotes employee satisfaction. Models and supports the principles of good clinical practice with the research team.

     

    Research Administration

    • Assists principal investigators in preparing applications for funding and managing existing grants and contracts.
      Implements and interprets research and financial policies and procedures in conjunction with the Office of Sponsored Programs.
    • Works with Emergency Medicine faculty to identify new federal and foundation funding opportunities, provides insight on funding terms and conditions and submission requirements.
    • Ensures proper post award account creation in ARHLC financial systems, including Lawson, payroll, EPIC and purchasing based on specific grant or contract language. Coordinates sub-award agreement creation and monitoring with OSP.
    • Monitors funds on regular basis, reconciling faculty and staff salaries, subcontractor invoices, incoming sponsor payments, cost transfers and other allocable expenses ensuring financial compliance to reporting standards and funding agency requirements.
    • Provides regular financial status updates including fiscal projections to PIs and division administrator, and processes spending plan adjustments at the direction of faculty to meet project objectives.
    • Reviews and coordinates time and effort reporting for faculty and clinical research staff. Works with PIs to regularly monitor information and make changes as appropriate.
    • Responsible for timely assembly and production of annual federal/sponsor progress reports, just in time submissions, no-cost extensions, contract amendments and assists in the completion of required financial reports with OSPA.
    • Works with the clinical research team to ensure proper invoices are generated in a timely fashion on all studies, offering training and guidance as appropriate;
    • Assists principal investigators with internal and external budget development for grant applications, including negotiation of budgets with sponsor.
    • Works with the Office of Sponsored Programs to facilitate contract negotiations and execution.
    • Provides oversight of patient charges to fund accounts; verifies accuracy of all charges to fund accounts including salary and miscellaneous expenses. Oversees research fund closeout in conjunction with clinical research staff, OSP, OSPA and sponsor.

    Management, Coordination and Communication

    • Works with other departments/disciplines to coordinate all aspects of research projects, including billing and reimbursement.
    • Monitors, directs and performs day-to-day operations to ensure policies and procedures are being followed, objectives are being met and that services and projects are run efficiently and effectively.
    • Plans, directs, schedules and manages resources and efforts of teams to support the operational needs and strategic objectives
    • Serves as a liaison between the faculty and OSP, sponsors, CROs, and federal agencies.
    • Participates in division research meetings and sponsor study meetings/teleconferences.
    • Recruits and supervises research personnel, including training and mentoring research staff and providing opportunities for staff education, development, and professional growth.
    • Works with clinical leaders and staff to educate and engage patients and families in clinical research.
    • Establishes strategic plans, policies, and procedures to assist the division and department in fulfill its research goals and objectives.
    • Promotes the research activities within the division and participates in local and national meetings and works with the faculty to report results via publications and presentations.

    Study Initiation and Conduct

    • Coordinate Emergency Medicine research projects within the division and collaborates with clinical partners in the Emergency Department to successfully operationalize research projects.
    • Oversees and provides guidance to other research staff in study procedures and processes and monitors team workflow.
    • Performs all functions of a clinical research coordinator for a proportion of divisional studies.
    • Serves as a clinical research leader internal and external and advises other staff regarding complex protocols and projects.
    • Assists with basic data management and statistical analysis tasks

    Regulatory Compliance

    • Prepares and submits regulatory documents to the government and/or sponsor and provides oversight to other research staff responsible.
    • Prepares/submits budgets, budget justifications and other necessary documents for review by the IRB, CRU and sponsor.
    • Assists with maintenance of investigator/sponsor files in accordance with FDA and Good clinical Practice (GCP) Guidelines.

    Leadership Competencies

    Personal Leadership

    • Acts with integrity
    • Builds trusting relationships
    • Approachable; seeks to be helpful
    • Leads from strengths and strives to improve weaknesses
    • Thinks strategically and communicates with others frequently
    • Leads with flexibility and adaptability
    • Models and holds self accountable for Lurie Children’s values and core competencies (service, innovation, and teamwork)
    • Leads with courage and confidence
    • Seeks to continuously learn and improve by soliciting and acting on feedback
    • Takes initiative to build knowledge by leveraging resources and asking questions

    Organizational Awareness and Alignment

    • Shares subject matter expertise
    • Frequent and clear communication in all directions to ensure alignment
    • Identifies and collaborates with stakeholders to achieve results; drives to operational excellence
    • Is a good financial steward
    • Is an advocate for self and team members
    • Understands and models the Lurie Children’s culture by living the service principles and values
    • Thinks strategically and shares knowledge; sets and communicates priorities while cascading Lurie Children’s strategic goals
    • Understands organizational structure and navigates successfully
    • Builds and leverages relationships with stakeholders inside Lurie Children’s and beyond own team

    Leading Through Change

    • Leads change confidently and with competence by owning the message and “walking the talk”
    • Is strategic and helps others by communicating often, including providing rationale and vision for changes
    • Asks questions and shares assumptions to support and lead others through ambiguity
    • Is a self-directed learner; gathers knowledge about healthcare climate and cascades to others
    • Communicates and facilitates each initiative to adapt to a rapidly changing healthcare climate
    • Continuously evaluates and improves upon the change to speed up decision making and ensure the optimal solution is reached

    Influencing and Leading Others

    • Provides clarity by defining roles, responsibilities, and priorities
    • Holds self and others accountable
    • Helps team members grow and develop by finding opportunities and giving frequent feedback
    • Identifies gaps in team’s skills
    • Shares or develops tools and resources to fill gaps
    • Leads with compassion and authenticity
    • Increases span of influence with stakeholders beyond direct reports
    • Actively listens and seeks to understand
    • Breaks down complex problems and helps to set goals and expectations
    • Engages and empowers others; has a mindset of developing others for their own growth and the organization’s success
    • Champion of Lurie Children’s mission and strategic goals by modeling the service principles
    • Proactively addresses performance issues and conflict
    •  

    • General Understadning and Nature of the Position Description
    • In accordance with the Americans with Disabilities Act, the above statements are intended to describe the general nature and level of work being performed by people assigned to this job classification.  These statements are not intended to be an exhaustive list of all responsibilities, duties and skills of personnel so classified.

     

    Qualifications

    1. Master's degree in a related field with 3-5 years of experience in clinical research, OR Bachelor's degree with 8-10 years of experience in clinical research financial management or research award administration.
    2.  Certification as a clinical research Professional (SOCRA) or clinical research Coordinator (ACRP) preferred. .
    3.  Expert knowledge of FDA guidelines and good clinical practices. 
    4.  Excellent leadership skills, ability to work with a team, excellent oral and written communication skills, good analytical ability, excellent organizational skills, understanding of financial budgets and reports, knowledge of hospital information systems.
    5.  Candidate must be able to make independent decisions, establish priorities, and react promptly with minimal supervision and a high level of discretion and confidentiality.
    6.  Knowledge of OMB circulars including A-21, A-110, cost accounting standards, indirect cost rate application, FAR and CFR.
    7.  Employee supervision and management experience strongly desired.
    8.  Project management experience desired.
    9.  Experience with Cayuse 424/SP helpful.
    10.  Working knowledge of basic data management and statistical analysis desired

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