EVMS

  • Coordinator of Clinical Research

    Position Number
    2081201
    Department
    OB/GYN
    Category
    Research
    Compensation Max
    USD $69,711.00/Yr.
    Compensation Min
    USD $53,624.00/Yr.
    Location : Location
    US-VA-Norfolk
  • Overview

    The position of Coordinator Clinical Research is under the direct supervision of the Director of MFM or his/her designee. A broad overview of the scope of responsibility for the wide variety of duties of this position includes the following as it pertains to research conducted by the divisions of MFM.

    Responsibilities

    Regulatory

    • Maintains all clinical study regulatory files (maintains all correspondence for regulatory files, obtains and delivers IRB correspondence, etc.) 
    • Is responsible for all Institutional Review Board submissions (EVMS and CIRB) and follow-up, including amendments, continuing reviews, insuring PI signature both electronic and paper and delivering hard copies of same.
    • Responsible for tracking regulatory, budget and contractual processes and keeping them moving forward and reporting status to the Director of MFM on a weekly basis or as indicated.  Updating the study tracking process sheet in real time.
    • Responsible for all Office of Research documents pertaining to research studies (ORAP Checklist, financial disclosure forms, updated CVs, obtaining all necessary signatures), delivery, and pick-up of same.
    • Responsible for all communication with SNGH and CHKD research departments to obtain required approvals and updates for research conducted there.
    • Maintains and acquires updated lab certifications, CLIA certificates for laboratories utilized by the MFM studies both at HH, Riverside, and Princess Ann offices.  Maintains an Excel (or related software) sheet of this and scanned copies accessible via the computer.
    • Maintains and acquires copies of all training required for research investigators and their staff, genetic counselors, and Ultrasonographers, other staff, fellows, residents and students listed on studies, updated CVs and licenses for all study staff for files, regulatory binders and forwarding to sponsors.  Maintains an Excel (or related software) sheet of this and scanned copies accessible via the computer.
    • Acts as a resource for helping all of the MFM staff obtain and maintain research required training
    • Maintains files of computerized standard letters and forms for study specific needs and correspondence.
    • Maintains a list of all studies and status of studies.
    • Compiles reports using Power Point (or related software)
    • Responsible for keeping study activity updated in computer files and regulatory binders.
    • Handles transmission and receipt of faxes, FedEx and UPS mail between sponsors and site.
    • Arranges meetings and meeting rooms as required
    • Provides interdepartmental support as needed
    • Other duties as assigned requested or required by the Director of MFM.

     

    Study Coordinator

    • Manage studies per FDA, GCP and ICH regulations following the guidelines that apply
    • Develop Informed Consents, obtain informed consent and assure that anyone listed on the study delegated to obtain consent is doing so per regulations and that consent is documented appropriately and maintained per SOPs for review.
    • Develop source documents, complete as needed and review and document where and how source was obtained.
    • Develop case report forms for investigator initiated studies.
    • Enter data on study specific electronic databases or case report forms.
    • Assist with the development of data collection and for investigator initiated studies.
    • Review medical records and assemble and clarify data required.
    • Complete literature searches for clinicians and summarize as required.
    • Respond to sponsor inquiries and requests.
    • Responsible for writing and revising Clinical Research SOPs tailored to the MFM,
    • Prepare for and facilitate EVMS internal study audits of studies.
    • Attend various conferences, both by phone and central meeting with other centers and sponsors pertaining to current or proposes studies.
    • Respond to sponsor site questionnaires and conduct site evaluation visits as needed, providing updated patient demographics and area census information.
    • Recruit and manage volunteers, organize and assist with clinical examinations; provide health education and referrals as necessary; schedule follow-up appointments.
    • Independently evaluate patients at visits that do not need clinician presence.
    • Complete documentation in case report forms; develop and maintain study specific source documents.
    • Work with study sponsor and monitors to resolve queries.
    • Accountability for procuring, storing, dispensing and retrieving test articles and maintains temperature logs.
    • Assist investigators in developing new protocols
      • Review developed protocols
      • Provide narrative on study visits, procedures, and risk factors
      • Assist with Inclusion and Exclusion criteria
    • Collect biological samples, including drawing blood, prepare store or ship as required and maintain log book.
    • Arrange for ordering study supplies.
    • Provide pricing of study procedures and supplies as needed for development of budgets, along with T&E of staff being charged to study.
    • Coordinate with MFM pre study start up, interfacing with scheduling, billing, health services and other required areas. Continuous communication with all areas to update on study status.
    • Responsible for the reporting of all Serious Adverse Events (IRB, CRO and sponsor submissions)
    • Maintain recruiting bulletin boards and provide staff education
    • Review clinical patient appointment schedules for possible eligibility of participants in clinical studies
    • Conducts audits of new investigator initiated studies after enrollment begins and periodically thereafter. Review findings and give written report to study PI.  Provide a quarterly or semi-annual combined report to the director of MFM.  These reports should not identify the individual studies or PIs but provide general findings, both positive and negative.
    • Maintains required certifications (i.e. BBP, CPR, HIPAA, IATA)
    • Submits new study review reports to director of MFM on a semiannually basis
    • Meet 2 times a month with director of MFM

    Qualifications

    Bachelor’s degree in science related field. RN Preferred.  5 years of clinical practice experience, ability to think and work independently, insight, excellent organizational skills, astute and accurate patient assessment skills, and the ability to identify and assign priorities.  

    Location : Location

    US-VA-Norfolk

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