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 (NMG).
The Clinical Research Nurse 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. The CRN adheres to the ANA Scope and Standards of Practice of Professional Nursing and the Code of Ethics. The CRN utilizes the NIH Clinical Research Nurse Domain of Practice and Model of Care. The CRN reflects the mission, vision, and values of Northwestern Medicine, 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.
- Leads the coordination and support to Principal Investigator(s).
- Guides the review, revision, and maintenance of protocols. Assures established protocols meet compliance and regulatory requirements.
- Provides guidance to clinical research nurses on projects related to new research study submissions, utilization reviews, wording/phrasing of medical orders, protocols and workflows.
- Develops and maintains clinical nursing research policies, standard operating procedures, and guidelines.
- Reviews and trends research-related deviations and workflow events, reports findings to the Manager and PI, and recommends action to ensure compliance.
- Supports the development of projects created in response to research-related problems and events as identified and reported by staff and research study team members (e.g., events, deviations, corrective and preventative actions).
- Collaborates with practice leadership, educators and peer CRNs to orient and train new staff to clinical research.
- Collaborates with practice leadership, educators, and peer CRNs to identify training needed for clinical research nurses about unfamiliar practices, procedures and medications to ensure patient/subject safety and compliance with protocols and regulatory requirements.
- Escalates research-related concerns to the appropriate leader or committee.
- Serves as a mentor and role model for communication and collaboration with investigator teams and clinical and technical research practices.
- Supports the clinical research nursing staff during adverse events, emergencies, and difficult clinical situations.
- May provide clinical nursing support to outpatient teams on an as needed basis.
- Participates in unit/departmental/divisional or hospital committees/task forces as assigned.
- Remains clinically proficient within area of expertise.
- Current license as a Registered Nurse State of Illinois Professional Nurse.
- BSN with a minimum of two years related clinical experience.
- CPR-BLS Certification through American Heart Association (AHA)
- Membership in Professional Nursing Organization
- ACLS Certification in clinical areas where required
- Society of Clinical Research Associates' (SOCRA) or Association of Clinical Research Professionals (ACRP) Certification
- Experience in clinical trials
- Certification in area of clinical specialty.