Clinical Research Assistant I

Clinical Research Assistant I
August 4, 2022
United States
Job Type
Work Setting


The Clinical Research Assistant I will

  • Assist Principal Investigators (PIs) in planning and implementing clinical research studies as assigned. Under the direction of the PI, coordinate preparation of protocol applications for submission to the IRB, sponsor, or regulatory authority. As directed by the PI, correspond with the IRB, study sponsors, clinical research organizations, study participants, and referring physicians.
  • Recruit study participants for enrollment in clinical trials. Follow individual study protocols. Complete informed consent procedures as assigned. Organize strategies for recruiting study participants and screen study participants for eligibility as required. Complete follow-up with the study participants in prescribed settings as needed.
  • Organize study procedures and schedules study participants for study visits. Assist the PI during patient visits. Perform study procedures designated for the Study Coordinator.
  • Complete record abstraction of source documents, conduct required study measurements, and complete study Case Report Forms in accordance with the best practice methods. Conduct a QC check of completed CRFs before submission for data entry; coordinate resolution of all data queries. Complete data entry as warranted.
  • Comply with all institutional policies and government regulations pertaining to human subjects protections. Maintain regulatory binders, case report forms, source documents, and other study documents. Monitor the occurrence of clinical adverse events, and report any to the PI, the study sponsor, and the IRB. Update protocol and amendment changes.
  • Assist investigators in data and document preparation for journal publication. Perform literature searches and pull articles.

To qualify

you must have:

  • Bachelor’s degree


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