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Phlebotomist/Medical Assistant - On Call

JOB SUMMARY:

The Research Assistant is an entry level position assisting in a variety of duties involved in the collection, compilation, and documentation of clinical research data in various departments as assigned. All data collected is quality control reviewed and is compliant with study and non-study regulations including, but not limited to the study protocol, HIPAA, OSHA, GCP, GDP, CFR, ICH Guidelines and site SOPs and Work Instructions.

ESSENTIAL JOB FUNCTIONS:

  1. Follow all study and non-study regulations including, but not limited to: Patient/Volunteer Privacy (HIPAA), OSHA, Good Clinical Practice (GCP), Good Documentation Practice (GDP), Standard Operating Procedures (SOP), and department specific Work Instructions (WI).
  2. Follow proper safety and emergency policies and procedures as set forth by WCCTG.
  3. Perform basic medical front office duties, including but not limited to: Welcoming study participants, answering or referring inquiries, and recording and/or collecting study participant information, verify volunteers information update to most current, have study specific charts ready for each day.
  4. Perform and complete study procedures, including but not limited to: Vital signs, electrocardiogram, height, weight, specimen collection, meal distribution, pulmonary function tests, check in/out of volunteers, etc.
  5. Assists with the floor set up for study procedures. May also assist with other preparation and setup of work area (ex. Make beds, assemble/disassemble cots).
  6. Performs data processing tasks for each study, including entering data, verifying data, identifying problem data, and performing data corrections and query resolutions when necessary.
  7. Maintain assigned work area in a clean and safe condition.
  8. Monitor own work and resolve queries in a timely manner.
  9. Review Inclusion/Exclusion Criteria and Source Documents for all screening visits conducted
  10. Ensure availability of study participant’s information by accurately filing and/or retrieving study participant records as requested by management.
  11. Adhere to project work plans and revisions as appropriate to meet any change in needs and requirements.
  12. Perform 100% quality control review of all completed screening sources and ensure all data is present for Investigators to review and sign to determine volunteer eligibility.
  13. Maintain the list of subjects eligible for check in/randomization and ensure this information is communicated to study team members.

QUALIFICATIONS:

Education

  •  High School diploma or General Education Degree (GED) required
  •  3-6 months related experience and/or training, or the equivalent combination of education and experience is preferred

Experience/Training

  •  1-3 months related experience and/or training, or the equivalent combination of education and experience is required
  •  Modules, SOPs/WI, Study-related training prior to performing study-related procedures
  •  Previous experience as a medical assistant or research assistant is preferred
  •  Ability to read and interpret documents such as Standard Operating Procedures (SOP), safety rules, study-related forms and documents. Ability to write routine reports and accurately record information on forms and/or documents. Ability to effectively communicate with volunteers, employees, supervisor, and others on study-related matters in English is necessary

Certifications

  •  Current BLS certification is required
  •  Medical Assistant (MA) and/or CPT1 certificate is required
  •  IATA Dangerous Goods Regulations (DGR) certification (required for shipping/handling specimen samples)
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