Clinical Research Coordinator II

Creighton University•Omaha, NE
•Onsite

About The Position

The Clinical Research Coordinator gathers research information for clinical projects and manages the clinical course of research participants according to research protocols. The coordinator selects and observes subjects, assists with data analysis, and uses discretion, creativity, and latitude in decision making. This position is scheduled Monday through Friday during daytime hours at 7500 Mercy Rd. (CHI/CUMC Bergan Mercy). The coordinator meets with study participants, follows study protocols, conducts required tests and procedures, collects data, and records findings in research case report forms and source documents. Tests and procedures may include bone density scans, EKGs, balance testing, mental and physical assessments, blood draws, vital signs, and diary instruction and review. The coordinator also schedules procedures, obtains medical records, maintains study supplies and drug inventory, distributes study drugs, and reports regulatory and Institutional Review Board issues as appropriate.

Requirements

  • Bachelor's degree in a related field; science preferred.
  • Four years of clinical experience, preferably in a research setting.
  • Knowledge of FDA regulatory requirements.
  • Knowledge of the principles of research design.
  • Ability to maintain confidentiality.
  • Ability to operate a personal computer and various software packages.

Responsibilities

  • Meet with study participants.
  • Follow study protocols while performing duties, testing, and data collection.
  • Conduct study-required tests and procedures, which may include bone density scans, EKGs, balance testing, mental and physical assessments, blood draws, vital signs, and diary instruction and review.
  • Record data and test results in patient research case report forms (CRFs), and respond appropriately to abnormal results.
  • Maintain accurate CRFs and source documents.
  • Schedule appointments for procedures inside and outside the department.
  • Obtain medical records for research hospitalizations.
  • Maintain study drug and supply inventory and manage study drug disbursement.
  • Report adverse events and other regulatory or Institutional Review Board issues appropriately.
  • Perform other duties as assigned.
  • Assist with data analysis.
  • Select and observe research subjects and manage their clinical course according to the research protocol.
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