Yale New Haven Health System

  • RESEARCH PROJECT COORD

    Job ID
    66857
    Department
    EPILEPSY/CAVE
    Category
    RESEARCH
    Position Type
    Full Time Benefits Eligible
    Scheduled Hours
    40
    Work Schedule
    DAYS
    Work Days
    MONDAY - FRIDAY
    Work Hours
    8:30 AM - 5:00 PM
    Work Shift
    N/A
    Requisition ID
    2018-20494
  • Overview

    To be part of our organization, every employee should understand and share in the YNHHS Vision, support our Mission, and live our Values. These values—integrity, patient-centered, respect, accountability, and compassion—must guide what we do, as individuals and professionals, every day.

    Manages, coordinates and participates in multiple complex clinical research investigations and research database projects in the Department of Neurophysiology. Functions as the epilepsy division research projects operations manager. Lead and direct various research teams to conduct clinical research projects in accordance with study protocols. Ensure new and ongoing training for research personnel, monitor adherence to standard operations procedures, good clinical practice and FDA regulations. Maintain and develop positive professional relationships internally and externally. Provides expertise and leadership to advance clinical research. Overall responsibility for preparing and overseeing the direction, planning, execution and interpretations of complex research proposals and clinical trial operations.

    EEO/AA/Disability/Veteran

    Responsibilities

    • 1. Oversees, coordinates and assesses the day-to-day operation of the research projects. Coordinates and trains staff.
    • 2. Oversees the planning of the study; establishing goals and objectives; training requirements; productivity goals and financial parameters.
    • 3. Indicates and coordinates public awareness and information on the studies.
    • 4. Coordinates and conducts regular meetings with staff, principal investigators and the study collaborators to ensure that the goals and objectives are met.
    • 5. Makes final determination on the eligibility of a study subjects for the research project. Decides on interview schedules, interviewing methods and coordinates all ongoing research studies. In conjunction with Principal Investigator, develops protocols for collection of data for research projects; designs data gathering instruments and related procedures; tests, refines and finalizes instruments for use in the research study.
    • 6. Designs and develops logs, files, records, questionnaires and other related materials to obtain data and maintain records.
    • 7. Determines procedures for data collection which are consistent with outside organizations and the research projects.
    • 8. Prepares Human Investigation Committee applications and reapprovals.
    • 9. Ensures the appropriateness of research protocols and interviewing techniques. Monitors quality of data collection and interviews.
    • 10. Ensures the adherence to regulations established by the federal government, pharmaceutical companies, Yale-New Haven Hospital, Yale University and outside agencies.
    • 11. Prepares documents for various agencies and internal committees for approval of new studies or reapproval of existing studies.
    • 12. Supervises and coordinates research data which includes the collection, verification and processing of data from study subjects.
    • 13. Prepares study reports utilizing a variety of computer software packages including OnCore and MS Office Suite: Word, Excel, PowerPoint, Access and Visio. Proficient utilization of EMR - Epic, Centricity and Electronic Data Capture software.
    • 14. Monitors the study budget and resources utilized and reports regularly to supervisor in conjunction with the respective business offices.
    • 15. Reviews with principal investigator study results to ensure the validity of the research projects.
    • 16. Interacts with internal contacts such as research staff; principal investigators; clinical staff; administrators; various Yale-New Haven Hospital and Yale University departments; and Directors to discuss and collaborate on research issues; and to design, develop, and coordinate research plans, techniques and methodology for research study.
    • 17. Interacts with external contacts such as staff at participating hospitals; principal investigators at other institutions; extended care facilities; funding agencies; various government agencies and vendors to solicit information and consult on methodologies for the research study.
    • 18. Leads and facilitates collaboration of clinical research staff with multidisciplinary clinical staff including: YNHH, YU, and YMG departments of pharmacy and clinical labs both on and off-site. Further liaises with both YNHH and YU areas including: Covance, CRO and other university labs. Shipping and receiving (oversees inventory of clinical research supplies, study drug and device accountability; shipping biological specimens), business departments, client interactions (pharmaceutical and clinical research organizations).
    • 19. Provides expertise and leadership to advance research in the epilepsy division of neurology.

    Qualifications

    EDUCATION


    Bachelors degree in public health, neuroscience, nursing, healthcare or related field. Master's degree preferred.


    EXPERIENCE


    Minimum of six (6) to eight (8) years in a high volume complex clinical research office with six (6) years of direct experience in project administration and management of multiple multi-center investigator Phase I - IV clinical trials or equivalent required. Highly developed communication skills, proven ability to work with a wide range of professionals. Proficient in medical terminology, physiology and pharmacology. Experience required in navigating clinical research regulations including but not limited to ICH/GCP and CFR regulations. Clinical software expertise with Epic, Citrix, OnCore, Redcap, MS applications, research databases and electronic data capture (EDC) systems required.


    LICENSURE


    N/A


    SPECIAL SKILLS


    Proven leadership and project management skills. Proven ability to manage and monitor policies, practices and procedures of research staff. Well-developed oral and written communication, organizational, analytical and training skills. Comprehensive knowledge of research methodologies including regulatory and GCP policies pertaining to research involving human subjects. Demonstrated knowledge of pharmaceutical drug and FDA device development. Strategic ability to establish, maintain and develop collaborations both internally and externally. Independent decision making, problem solving and negotiation skills. Proficiency in various data management and software programs to support clinical research.


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