• Study Coordinator

    Location US-MD-Bethesda
    Job ID
    2018-1788
    Category
    Clinical
    Type
    Regular Full-Time
  • Overview

    Social & Scientific Systems (SSS) works to improve public health worldwide by providing technical, research, and program management services to government, nonprofit, and commercial clients.  The SSS team offers a synergy of expertise in clinical research services, epidemiology and public health studies, health data management and analysis, and program evaluation and policy analysis.  Please join our dedicated staff of employee-owners in an environment that values diversity and supports health, well-being, and professional growth.

     

    SSS is seeking a Study Coordinator to support clinical research conducted by investigators at the Clinical Research Branch of the National Institute of Environmental Health Sciences (NIEHS).  You will be supporting studies focused primarily on autoimmune disease and environmental exposures.  The ideal candidate will have some experience in FDA-monitored studies and be a motivated, detail-oriented individual with excellent communication and organizational skills. The full-time position will be based in Bethesda, MD at the NIH Clinical Center with tasks being assigned by the Project Manager, Study Investigators and other staff.

    Responsibilities

    Lead study activities that include, but are not limited to, patient enrollment and scheduling, regulatory submissions, providing laboratory support, timely preparation of adverse event reports, and assist with general study administrative responsibilities.  Requires ability to multi-task and manage time effectively with minimal supervision.

     

    Essential Functions

    • Implement study activities in accordance with NIH and FDA regulations
    • Complete patient enrollment activities including recruitment, screening, scheduling, follow-up and payment
    • Draft and finalize IRB submissions and stipulations including initial and annual reviews, amendments, and assembly and mailing regulatory packages to the FDA
    • Create, prepare, and review study forms and complete quality control checks per FDA and NIEHS Environmental Autoimmunity Group (EAG) guidelines
    • Work with Data Managers and Data Team members for forms preparation, and completion of adjudication
    • Draft changes to protocol and protocol related study materials as needed
    • Liaise with internal and external study team members and collaborators
    • Develop and maintain study manuals and tracking sheets
    • Timely preparation and submission of adverse event reports
    • Coordinate and assist with sample delivery and pick-up as needed
    • Provide progress and technical reports on a regular basis, and as requested
    • Provide other support to cover various study needs as directed
    • Coordinate, attend, and on occasion lead study-related meetings
    • Train study members

    Qualifications

    Skills Required

    • Ability to plan, prioritize and organize work-flow and procedures
    • Ability to enter and audit data into web/PC-based software using Windows based applications
    • Excellent communication skills
    • Ability to write clearly and concisely for regulatory reporting and submissions
    • Work independently with minimal supervision

    Desired Skills and Experience:

    • Familiarity with NIH and/or FDA regulations for conducting human subjects research
    • Experience with patient interaction, phone screening and scheduling
    • Adverse event reporting per clinical standards and FDA requirements
    • Strong proficiency with MS Word, Outlook, and Excel, full MS Office experience preferred
    • Experience working in a research environment
    • Knowledge of medical terminology

     

    Education or Equivalent Experience:

    • Bachelors or masters degree or equivalent combination of training and experience in public health, clinical research, nursing, epidemiology, or related field
    • 2 years experience either monitoring and/or in the role of a study coordinator wokring on FDA/IND trials

     
    SSS is committed to fostering a diverse workforce and is proud to be an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, national origin, or protected veteran status and will not be discrimated against on the basis of disability.

     

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