Research Assistant – Orlando

The responsibility of a Research Assistant is to assist the Clinical
Research Coordinator in conducting clinical trials while performing a
variety of administrative and clinical study activities including
scheduling appointments, giving information to callers, screening
patients, and conducting protocol related procedures, therefore relieving
the Research Study Coordinator of clerical work and minor
administrative or clinical procedure details.

  1. Provide clerical and administrative support for the Study Coordinator
  2. Complete organizational tools for conducting the study accurately
    and in compliance with GCP, as requested
  3. Abstract data from medical records, consultations and referral notes
    to complete study forms and flow sheets
  4. Assist in the preparation of case report forms by recording accurate
    and timely data for sponsor/audit review
  5. Keying data into data bases – each specific to individual trials
  6. Correct and edit CRF entries
  7. Resolve data queries
  8. Transmit data via fax, mail or electronically
  9. Maintain scheduling of study participants’ visits
  10. Assist in communication with the Sponsor regarding study activities
    as necessary
  11. To use computer applications to enhance the efficiency of workflow
    and study activities
  12. Assists in Source document preparation
  13. Assist Study Coordinator with recruitment materials
  14. Answer and screen research related telephone calls, and arrange
    conference calls
  15. Assist in preparing and submitting regulatory documents to the
    sponsor, including laboratory certification, normal values,
    curriculum vitae, licenses, etc
  16. Assist in preparing and submitting regulatory documents IRB
  17. Maintain patient screening and enrollment logs
  18. Fax enrollments logs to appropriate sponsor on weekly basis
  19. Coordinate and arrange meetings, prepare agendas, reserve and
    prepare facilities, and record and transcribe minutes of meetings
  20. Read and route incoming mail. Locate and attach appropriate file to
    correspondence to be answered by Study Coordinator
  21. Organize and maintain file system, and file correspondence and other
  22. Assist during subject visits per delegated duties (i.e. take vitals, draw
    blood, perform EKG’s, perform spirometry, etc.)
  23. Coordinate, schedule and participate in monitor visits
  24. Arrange and coordinate travel schedules and reservations
  25. Make copies of correspondence or other printed materials
  26. Prepare outgoing mail and correspondence, including e-mail and
  27. Order and maintain supplies, and arrange for equipment maintenance
  28. Participate in educational/training activities
  29. Attend continuing education offerings, study meetings, educational
  30. Assist in development of new research ideas
  31. Retrieve and view and/or copy charts from medical records
  32. Maintain a list of sponsor/CRO contacts for each protocol
    To perform this job successfully, an individual must be able to perform
    each essential duty satisfactorily. The requirements listed below are
    representative of the knowledge, skill, and/or ability required.
    Reasonable accommodations may be made to enable individuals with
    disabilities to perform the essential functions.
  33. High school diploma or general education degree (GED); at least 1
    year of experience in a health care environment, one to three months
    research experience and/or training
  34. Possess an in-depth knowledge of FDA guidelines, “Good Clinical
    Practice” from the Code of Federal Regulations, research source
    documentations and record storage
  35. Must be motivated, organized and be able to function independently
  36. Neat and legible handwriting
  37. Ensure the availability of accurate and timely information
  38. Attentiveness to details
  39. Multi-tasking capability
  40. Good interpersonal, written and verbal communication skills
  41. Proficient PC user with excellent software user capabilities including
    Microsoft Office & Excel. As well as, an accelerated aptitude for
    learning new sponsor mandated programs
  42. Ability to prioritize task directives from multiple levels of
    management simultaneously
  43. Ability to respond to common inquiries or complaints from sponsors
    and monitors
  44. Ability to work protocol required hours, including extended hours
    and weekends.
  45. Perform any other duties as assigned by management.
    While performing the duties of this job, the employee is regularly
    required to use hands and arms; stoop, kneel, crouch, or crawl. The
    employee frequently is required to stand, walk, and sit. The employee
    must occasionally lift and/or move up to 20 pounds.
    SCHEDULE: Full Time 8:30 to 5pm; however, hours vary depending on subject
    visits. Overtime shall be compensated per state law.

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