Research Nurse Coordinator II - Gastroenterology; IBD

Position Summary

Functions as the lead person on a research project; coordinates enrollment of study subjects; ensures adherence to study procedures consistent with the study protocol and verifiable source documentation; may supervise personnel assigned to work on the study. Coordinates with multidisciplinary teams to maintain continuity of care and human subject protection with a commitment to research integrity. May perform duties inclusive of those delegated to a Research Nurse Coordinator 1.

• Works under the Principal Investigator’s (PI) guidance to meet the research objective of the project.
• Facilitates and implements study start-up activities including trial feasibility assessment; study logistics; IRB (both local and central) submissions and other applicable regulatory requirements; budgetary and contract review and approval.
• Provides direct patient care, including assessment, planning, implementation and evaluation of patients; documents, collects data and assists physicians.
• Works with research team to identify, screen and enroll study subjects.
• Ensures protocol requirements are met including but not limited to direct contact with research participants; collection of basic health information; coordination of study related procedures; handling, processing and shipping of research specimens, source documentation and data entry.
• May train and supervise staff assigned to work on the research project(s).
• Coordinates handling of specimens, administration of clinical trials, collection of source information and case reporting.
• Prepares/submits reportable event reports to sponsor(s), IRBs and regulatory agencies in accordance with the study protocol and established policies, procedures, and regulations.
• Collaborates with sponsor’s research associates during monitoring activities by providing study documentation, data clarifications and reports as necessary.
• Authorizes payments to ancillary organizations for services rendered and reconciles payments from organizations serviced.
• Demonstrates experience in clinical trials management including strong organizational skills, independence and resourcefulness and an increased responsibility for the day-to-day conduction and oversight of multiple clinical trials.
• Provides oversight of administration of study medications and/or study interventions, as appropriate. Administers investigational products in approved settings.
• Educates staff nurses caring for research patients by providing necessary information about the research study including intervention and potential adverse events and required study procedures.
• Performs other duties incidental to the work described above.

• Normal office environment
• Exposure to blood-borne pathogens
• Requires protective devices
• Patient care setting
• Direct patient care setting

• Typically sitting at desk or table
• Typically bending, crouching, stooping
• Occasional lifting (25 lbs or less)

• Office equipment
• Clinical/diagnostic equipment

Associate Degree in Nursing or Diploma in Registered Nursing

• Basic Life Support
  - American Heart Association
• Basic Life Support
  - American Red Cross
• Registered Nurse
  - Illinois Department of Financial and Professional Regulation
• Registered Nurse
  - Missouri Division of Professional Registration

Research (2 Years), Nursing (2 Years)

Not Applicable

A driver's license is not required for this position.

• Clinical Research Certification
• No additional education unless stated elsewhere in the job posting.
• No additional certification/professional licenses unless stated elsewhere in the job posting.
• No additional work experience unless stated elsewhere in the job posting.
• Active Listening, Clinical Research Coordination, Clinical Research Management, Clinical Research Methods, Clinical Research Operations, Clinical Techniques, Database Management, Detail-Oriented, Effective Written Communication, Electronic Health Records (EHR), Nursing Fundamentals, Oral Communications, Patient Recruitment, Reporting…