This position is responsible for coordinating clinical research for departmental research activity.

• Regulatory

  • Maintains clinical study regulatory files (maintains all correspondence for regulatory files, obtains and delivers IRB correspondence, etc.) 
  • Responsible for Institutional Review Board submissions (EVMS and CIRB) and follow-up, including amendments, continuing reviews, ensuring PI signature both electronic and paper.
  • 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. 
  • Responsible for all Office of Research documents pertaining to research studies (ORAP Checklist, financial disclosure forms, updated CVs, obtaining all necessary signatures).
  • Responsible for Medical Student Research Office communication, including ensuring medical students are approved to work on research studies.
  • Responsible for communication with SNGH and CHKD research departments to obtain required approvals and updates for research conducted there.
  • Maintain 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.
  • Maintain 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.
  • Act as a resource for helping MFM staff obtain and maintain required research training.
  • Maintain files of computerized standard letters and forms for study specific needs and correspondence.
  • Maintain a list of all studies and status of studies.
  • Compile reports using Power Point (or related software).
  • Responsible for keeping study activity updated in computer files and regulatory binders.
  • Handle transmission and receipt of faxes, FedEx and UPS mail between sponsors and site.
  • Arrange meetings and meeting rooms as required.
  • Provide interdepartmental support as needed.
  • Other duties as assigned requested or required by the Clinical Research Manager.

   

  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 data collection for investigator-initiated studies.
  • Review medical records and assemble and clarify data required.
  • Assist with study recruitment.
  • Complete literature searches for clinicians and summarize as required.
  • Respond to sponsor inquiries and requests.
  • Responsible for writing and revising Clinical Research SOPs.
  • 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.
  • Complete documentation in case report forms; develop and maintain study specific source documents.
  • Work with study sponsor and monitors to resolve queries.
  • Assist investigators in developing new protocols
    • Review developed protocols
    • Provide narrative on study visits, procedures, and risk factors
    • Assist with Inclusion and Exclusion criteria
  • Facilitate the collection of biological samples, including drawing blood, prepare store or ship as required and maintain log book.
  • Assist with 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)
  • 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 Clinical Research Manager.  These reports should not identify the individual studies or PIs but provide general findings, both positive and negative.
  • Maintains required certifications (i.e. BBP, HIPAA, IATA)

Candidate should possess extensive clinical research work 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.

Bachelors ina science related field is preferred, but not required.