Clinical Research Specialist

UNC Health•Raleigh, NC
•Onsite

About The Position

The Clinical Research Specialist conducts clinical studies according to study protocols, educates patients and families about clinical trials, and ensures compliance with established protocols, IRB policies and procedures, study requirements, and federal regulations. The role is based in the Cancer Center Research unit at UNC REX Healthcare in Raleigh, North Carolina. It is a full-time, onsite position with a day schedule and 40 standard hours per week.

Requirements

  • Bachelor's degree in a clinical or health-related field.
  • Two years of clinical research experience involving specific patient populations and/or clinical trial experience or knowledge, or an equivalent combination of relevant education and experience.
  • Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
  • Ability to write routine reports and correspondence and speak effectively before groups of customers or employees.
  • Ability to perform basic arithmetic and calculate rates, ratios, and percentages, and to draw and interpret bar graphs.
  • Knowledge or ability in statistical reporting, trend analysis, statistical analysis, data verification, general data coding, and data analysis and interpretation.
  • Ability to apply common-sense understanding to instructions provided in written, oral, or diagram form and address problems involving several concrete variables in standardized situations.

Responsibilities

  • Review research protocols to determine resource availability and subject and equipment needs.
  • Educate patients and families about clinical trials, including their potential benefits and goals, and communicate with physicians and other staff about protocols open to enrollment.
  • Obtain written informed consent and appropriate HIPAA authorization from each patient before study enrollment.
  • Conduct studies according to protocol and follow established guidelines for data collection.
  • Ensure regulatory compliance for each study by following IRB policies and procedures, study requirements, and federal regulations.
  • Participate in sponsor audits and/or regulatory inspections of records and documents.
  • Recognize, support, and use evidence-based clinical practices.
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