Description
The Clinical Research Nurse Coordinator 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 Coordinator 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 Medicine; a joint collaboration between NMG and the NU Feinberg School of Medicine.
The Clinical Research Nurse Coordinator (CRNC) works collaboratively with the inter-professional team and peers to ensure appropriate implementation and conduct of clinical research studies throughout the lifecycle of a protocol. The CRNC adheres to the ANA Scope and Standards of Practice of Professional Nursing and the Code of Ethics. The CRNC utilizes the NIH Clinical Research Nurse Domain of Practice and Model of Care.
Responsibilities:
- Leads the coordination and support to Principal Investigator(s).
- Reviews research studies in pre-submission phase for feasibility of protocol implementation.
- 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 Inter-professional Quality Committee, 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 Clinical Coordinators, Education Coordinators, and peer CRNCs to orient and train new staff to clinical research.
- Collaborates with Clinical Coordinators, Education Coordinators, and peer CRNCs 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.
- Provides clinical nursing support to both inpatient and/or outpatient teams as needed as a cross trained resource.
Additional Functions
- Participates in unit/departmental/divisional or hospital committees/task forces as assigned.
- Remains clinically proficient within area of expertise.
Additional Responsibilities
Preparing materials for submission to the IRB and participating in protocol development by draftingstudy protocols and/or reviewing potential protocols to evaluate their effect on standard nursingprocedures; Acting as a protocol resource for other research team members;
Preparing financial records including quarterly reports, budget, and subject-related expense;Preparing for and completing close out procedures for terminated studies, ensuring all FDA,sponsor, and University regulations have been followed;
Collecting scientific samples and detailed, accurate data; Arranging follow up medical care toinsure ongoing monitoring of patients in research protocols; Reporting adverse events to principalinvestigator and/or sponsor in a timely manner;
Reviewing medical records; Reviewing clinical and laboratory evaluations; Maintaining appropriatesource documentation and appropriately and accurately completing patient charts and/or casereports; Evaluating and enrolling patients in clinical research studies; Obtaining patients’ informed-consent,
Providing direct patient care involving diagnosis, administration of medications, and performanceof tests under the direction of the principal investigator or supervising physician; Providing healthpractices information and education to patients regarding medications, diseases, diet, exercise,and any special procedures; Acting as a liaison for patient/physician telephone calls; Assistingpatients by providing appropriate referrals to physicians, clinics, or agencies;
Participating actively in clinical meetings, rounds, and departmental meetings;
Qualifications
Required:
- Current license as a Registered Nurse in the State of Illinois.
- Experience in clinical trials
- BSN
- Minimum of two years of related clinical experience.
- CPR-BLS Certification through the American Heart Association (AHA)
Preferred:
- MSN
- 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
- Certification in area of clinical specialty.
Equal Opportunity
Northwestern Medicine is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, disability, sexual orientation or any other protected status.
