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| Job Summary
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| This is a 50% FTE part-time position (days to be determined). The research assistant will participate in the Pulmonary Hypertension research program with responsibilities directly related to assisting the study coordinators administrating clinical trials in pulmonary hypertension and related laboratory responsibilities.
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| Organizational Status
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| The incumbent will report to the clinical trials physicians
(Drs. Swiston & Levy) and coordinator of the pulmonary hypertension clinic.
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| Work Performed
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| A. Typical Duties
Responsible for subject sample collection and preparation:
Conducts informed consent with potential study subjects in onsite settings as per GCP (Good Clinical Practice) Guidelines.
Administers questionnaires to study subjects.
Carries out functions outlined in the study protocol(s) such as assessing vital signs and collecting blood samples.
Administers oral study medication under supervision of PI and/or supplies appropriately as per study protocol, provides patient education on appropriate use and storage.
Performs venipuncture for blood collection and collects urine for analysis
Identifies, monitors and assesses subjects for adverse events and adheres to protocol under direction of the Investigator.
Informs investigator, sponsor and UBC Clinical Research Ethics Board of any Serious Adverse Events to patients during trial.
Performs dipstick urinalysis
Prepares, packages and sends blood samples to central laboratories situated elsewhere in North America. (ambient and frozen).
Separates serum and aliquots into vials for tests and storage
Prepares slides for differential and morphology
maintains documentation re lab samples (logs, requisition processing)
B. Responsible for preparation of clinic visits for study patients:
Execute screening questionnaire for potential study candidates
Prepare study forms for visits (requisitions, case report forms, source documents)
Prepare and deliver laboratory and other paraclinical test requisitions
C.Participate in study logistics:
Maintain regulatory files
Maintain lab documentation for local/central/satellite labs (current certifications, lab normals)
Receives lab reports and distributes to appropriate personnel, transcribes data when necessary, files reports appropriately
Monitors and maintains inventory of technical supplies
inputs electronic study data
Complete case report forms
Assist with scheduling and confirming patient appointments
Escorts study patients to various departments when necessary
Assist with review and recruitment of patients for clinical trials
Maintains and transmits study logs to sponsors
Ensure completion of Data Query Forms
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| Supervision Received
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| Receives detailed instructions during orientation and on subsequent new assignments or changes in procedures. Carries out familiar phases of the work under general supervision.
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| Supervision Given
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| Consequence of Error/Judgement
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| Works within well-defined guidelines and procedures, but is expected to exercise considerable initiative and judgment in establishing priorities, and carrying tasks through to completion. New or unusual problems would be referred to the study coordinator. Errors in this position would potentially result in incorrect data being collected on a particular study patient when related to error in form preparation or incorrect blood preparation and shipping. Subject records are highly confidential.
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| Qualifications
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| High School graduation or Undergraduate degree in a relevant discipline or Graduation from a technical college or institute, such as B.C.I.T. Current CPR certification and current Phlebotomy certification. 3 years relevant experience or the equivalent combination of education and experience. Previous experience in clinical drug trials, computer skills, medical terminology. Previous experience in conducting clinical trials, experience in venipuncture. Self-directed and has the ability to exercise judgment and initiative.
Team-oriented, committed and precise
Demonstrates responsibility and accountability.
Good organizational and communication skills
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