The Clinical Research Nurse reflects the mission, vision, and values of NM, adheres to the organization’s Code of Ethics and Corporate Compliance Program, and complies with all relevant policies, procedures, guidelines and all other regulatory and accreditation standards.
- The Clinical Research Nurse (CRN) is a registered professional nurse who demonstrates exemplary clinical research knowledge, has strong communication skills and is responsible for serving as a liaison between Northwestern University (NU) clinical research investigator teams (e.g., investigator-initiated trials, sponsor trials) and Northwestern Medical Group. Medical Group (NMG). The CRN works collaboratively with the inter-professional team and peers to ensure appropriate implementation and conduct of clinical research studies in NMG throughout the lifecycle of a protocol.
Responsibilities:
- Facilitates, maintains, and coordinates the logistical aspects of assigned study protocols with other research staff in accordance with Good Clinical Practice, standard operating procedures, applicable nursing practices and sponsor requirements.
- Provides direct nursing patient care including, but not limited to inpatient admission and discharge, where applicable, diagnosis, administration of medications, and performance of applicable clinical study-related tests as well as maintaining continual clinical assessment of study subjects under the direction of the principal investigator or supervising physician.
- Provides input into implementation of protocols including setting, systems issues, changes to assure that process will work in other areas if needed within NMH; Present information at weekly meetings in organized fashion; monitors budget for selected aspects of research studies.
- Attends investigator's meetings, coordinates, and attends pre-study site visits, study initiation visits, and all other study-related visits by Monitors or Sponsor representatives, when required.
- Arranges for procedures and necessary visits performed by external vendors that are necessary to the conduct of the study.
- Schedules and leads in-house protocol meetings to review study-related procedures, staffing and visit flow.
- Schedules and coordinates all medical needs and coverage for protocol related procedures.
- Maintains and documents all study-related communication including, but not limited to the principal investigator or supervising physician, study subjects,
- Sponsor or Sponsor representative(s) and IRB throughout the clinical trial.
- Responsible for giving subject instructions for study participation and serves as the primary contact for subjects by being available to handle study-specific questions, concerns, or events.
- Ensures all protocol procedures are completed per study requirements.
- Obtains and documents all adverse event/serious adverse event data on appropriate forms and reports adverse event data to the appropriate parties as outlined by the study protocol, regulations and applicable policies and procedures.
- Assures quality and completeness of source documents collected during the course of the study to assist with overall principal investigator review and approval.
- Ensures accurate, complete, and timely data entry into CRFs using 100% source documentation verification to assist with overall principal investigator review and approval.
- Schedules, leads, and assists with all study-related visits on site and is readily available during visits for applicable corrections, questions, or other study-related or site needs.
- Supervises document retention, security, and destruction, where applicable.
- Responsible for completing all necessary training for the position, including study protocol specific training and Health System policies and procedures.
- Trains other study specific research staff in collection and reporting of required data, where applicable.
- Maintains research files, designs forms as needed, reports findings as appropriate, assists in preparation or review of material for submission to an IRB including reviewing and editing protocols and consent documents, where applicable.
- Travels between hospital locations where research is conducted.
- Performs all other functions as related to this job and assigned.