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Clinical Research Nurse

4 months ago

Chicago, United States Medix™ Full time

Qualifications

  • 3 years of floor nursing experience required, would love candidate to have clinical research experience
  • Registered Nurse/RN in Illinois required
  • Ability to work on multiple projects simultaneously


Responsibilities

  • Under general supervision and according to standard practice or general instruction, directly supports the research initiatives
  • Collaborates with the physicians and clinical team in implementing investigator-initiated, industry-sponsored, as well as federally funded protocols, including multi-center clinical trials
  • Responsible for coordinating research studies from the initiation of the study to its completion, including but not limited to implementing clinical and non-clinical study procedures
  • Conducts protocol eligibility assessments, provides ongoing clinical and laboratory evaluation of study subjects, collects data and maintains confidential research records, provides study patient management according to protocol and regulatory requirements
  • Recruit, screen, enroll, and follow study participants over the course of a study as outlined in assigned research protocols
  • The study nurse will perform physical examinations on potential participants prior to randomization
  • Coordinates the implementation of clinical protocols
  • Works with sponsors, study staff, laboratory staff, data managers, pharmacists, clinic staff, investigators, and other departments to develop and implement protocol-specific standard operating procedures
  • Coordinates clinical and non-clinical study start-up activities including organization of study medical records and coordination of required laboratory and clinical evaluations
  • Performs patient recruitment and evaluates subjects for potential study qualification in accordance with protocol eligibility criteria, including: medical record review, interviewing, clinical and laboratory evaluations, obtaining informed consent
  • The study nurse will collect information necessary for reporting serious adverse events (including details of the hospitalization)
  • Conducts medical and social histories, clinical evaluations and orders laboratory and other procedures as required by protocol
  • Records/abstracts data in study source documents and on case report forms
  • Schedules and tracks study visits
  • Ensures that study drug is properly dispensed to patient and provides patient education regarding medications and laboratory results
  • Notifies principal investigator of any abnormal values and ensures follow-up and reporting of adverse events in accordance with regulatory requirements
  • Responsible for ongoing data collection and maintenance of confidential records
  • Reviews study forms, files and reports for completeness, accuracy, consistency and compliance (quality control)
  • Ensures appropriate and timely transmission of clinical data to data management center
  • Responds in a timely manner to requests for data clarifications and queries
  • The study nurse will assemble medical information (results of physical examination, ECG, vital signs) for review and presentation prior to randomization
  • The study nurse will review research billing