The Clinical Research Nurse collaborates with the physicians, nurses, and scientists associated with Clinical Trial studies, and the Clinical Research Office (CRO) staff, to ensure protocol compliance, patient safety, and data quality. The Research Nurse will participate in protocol development and be responsible for the recruitment, screening, and accrual of patients onto clinical trials as well as administering treatments as appropriate, managing toxicities, and collecting and documenting patient information pertinent to the trial in the patient record as well as the clinical research files. The nurse will also coordinate the follow-up care of the patient on study to ensure protocol compliance. This position reports to the Clinical Operations Manager of the Cancer Center CRO. As noted above, data management is an essential part of this position. The Clinical Research Nurse will submit appropriate data and case report forms completed in a timely manner which meets internal CRO standards. The accuracy and completeness of these forms is confirmed by team leaders and the Quality Assurance Coordinator within the CRO. With respect to daily clinical operations, the Research Nurse will work directly with PI.
Screens patients for eligibility for inclusion into the studies; Provide direct care to research patients, including drug administration, lab draws, coordination of appointments, follow-up and management of side effects, identification of home care needs.
Oversee care to assure protocol adherence is maintained by staff, serve internally as a resource for nursing (outpatient, inpatient, home care), medical staff and CRO staff; Responsible for collection and documentation of research data for designated patients within program meeting CRO consortia standards; On an as needed basis may be involved in review or documentation of data on patients outside of program area to meet external audit deadlines.
Facilitate transfer of nursing responsibilities for patient back to primary nurse (clinic, hospital, BMT) when patient is no longer actively being followed on a clinical trial.
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.
Participates in development of clinical trials as appropriate; participate in consortia meetings periodically; attends protocol start-up meetings; identifies problem areas in current clinical trials and seeks solutions to optimize quality patient care and assure completion of the trial.
Collaborates with the principal investigator in all aspects of research study; Monitors care of patients in accordance with research protocols and Good Clinical Practices and takes action to assure that patient care is delivered in accordance with policies of the particular care setting. (i.e. NMFF, NMH); Ensure that informed consent has been properly obtained; Prepare reports of Serious Adverse events; Communicate with local federal or commercial sponsors as appropriate; Assist CRO Staff with preparation for audits and answers queries promptly
Involved in providing staff education as needed for participation in particular research activities; Provides staff education on general clinical trial information; Assist in orientation of new staff members to CRO; Provides patient education in daily practice; Development of patient education materials or protocol tools specific to research study to facilitate trial compliance (i.e. standardized orders, patient management guidelines for housestaff, patient documentation tolls).
Performs other duties as assigned.
Current license as Registered Professional Nurse in State of Illinois.
BSN with 3 years clinical practice.
Clinical Research Coordinator certification (within 6 months of eligibility).
Involved in external professional organizations (e.g. Oncology Nursing Society, nursing committee co-operative groups) and obtains and maintains OCN certification within 6 months of eligibility if not already certified.
Minimum Competencies: (Skills, knowledge, and abilities.)
Ability to develop individualized case plans and maintain positive client relationships;
Successfully uses multiple software programs independently including Microsoft Office applications such as PowerPoint, Word, Excel, and Access, email, web browsers, and PeopleSoft
Demonstrated ability to communicate effectively one-to-one, in small groups and in public speaking contexts;
Ability to write precise, well-organized emails, letters and proposals while using appropriate vocabulary and grammar;
Demonstrated success following through on commitments while incorporating courage, objectivity, trustworthiness, honesty, respect and fairness in daily actions;
Demonstrated ability to integrate health and safety precautions into daily activities
Demonstrated willingness to strive for excellence with work processes and outcomes, honoring policies and regulatory requirements;
Demonstrated knowledge of federal and state regulations governing the participation of human and animal research subjects;
Preferred Qualifications: (Education and experience)
MSN with oncology specialty.
Oncology Nurse Certification (OCN®)
Preferred Competencies: (Skills, knowledge, and abilities)
Clinical research experience preferred including administration of investigational agents, coordination of clinical research and data collection/management.
Clinical Research Coordination certification.
Northwestern University is an Equal Opportunity, Affirmative Action Employer of all protected classes, including veterans and individuals with disabilities. Women, racial and ethnic minorities, individuals with disabilities, and veterans are encouraged to apply. Hiring is contingent upon eligibility to work in the United States.
Internal Number: 36064
About Northwestern University
Northwestern University is a major private research university with 12 academic divisions located on three campuses in Evanston, Chicago, and Education City in Doha, Qatar. We have approximately 2,500 full-time faculty members, 17,000 graduate and undergraduate students, and over 5,700 full and part-time staff. Northwestern University combines innovative teaching and pioneering research in a highly collaborative environment. It provides students and faculty exceptional opportunities for intellectual, personal and professional growth.