Summary of Essential Job Duties: The Research Nurse works under general supervision and reports to the SOCCI Clinical Research Office for all research related competencies, Quality Assurance, and compliance with GCP and applicable regulatory agencies (FDA, OHRP, NCI). Coordinates all aspects of research, including interactions with research personnel and project participants, data-related tasks, patient recruitment and logistical organization.
The Research Nurse ensures all research-related patient care and related family interactions are performed with sensitivity to the needs. Duties will include, but are not limited to: recruitment of study participants, documentation of study participant screening and enrollment, adverse events documentation, assessment/reassessment, and follow-up activities. Performs and coordinates study participant interventions as required. Serves as a liaison between study participant and PI or other research staff. Prepares data summaries and tables for Investigator and the CRO. Prepares and updates investigation binder and completes CRF’s (Case Report Forms). May assist in IRB submission preparation, data compilation, development of Working Instructions (WIs), publication preparation, and presentations.
May assist in training of other staff members. May be required to attend study meetings, prepare study documents for audit, help to build research infrastructure, assist in preparation and updating of clinical research policies and procedures, may be required to serve as liaison between the study site and sponsor, maintain on-going communications with IRB, SRFA and sponsors as needed, to facilitate research activities and endure compliance with all applicable regulatory and protocol requirements.
Experience: Minimum of two (2) years of clinical nursing experience with oncology preferred. At one to five (1 to 5) years of clinical research nursing experience. Excellent verbal and written communication skills required. Demonstrated commitment to quality service and care, team work, and CSMC goals. Demonstrated expertise/competency in area of research specialization. Demonstrated clinical competency. Knowledge of data analyses and applicable computer applications. Must beet all of the nursing and Supervisor Competency requirements. Knowledge of human resource and administration policies and procedures.
Educational Requirements: Bachelor of Science Degree, preferred. Master of Science Degree, preferred.
License/Certification/Registration Requirements: Valid California RN license and current BLS (Basic Life Saving Certification) required. BSN, CCRP (Certified Clinical Research Professional) certification from SoCRA or ACRP preferred and OCN preferred.
Physical Demands: Any combination of academic education, professional training or work experience, which demonstrates the ability to perform the duties required for the position.
