Research Coordinator - RN
CA Registered Nurse
At least one year experience required
Experience in an acute care setting required
JOB PURPOSEOversees study management including the distribution and/or administration of study medication and collection of laboratory data. Works closely with a variety of hospital and study personnel, as well as study participants and their families.
Acts as a liaison between the Principal Investigator (PI), Institutional Review Board (IRB), other hospital departments, and study participants for study management. Provides study information to physicians, nurses, pharmacists, and lab personnel. Arranges in-service trainings as appropriate. Responsible for implementation, data management, and follow-up of clinical trials to assure data accuracy, study participant safety, confidentiality, protocol compliance, and regulatory compliance as required by the clinical trial protocol and the study sponsor.? ·
Assists physicians in identifying eligible patients and in the informed consent process. Depending on study, may perform informed consent process. Coordinates all research activities of study participants, identifies lab work necessary for each study, and oversees study drug administration. Monitors and reports adverse events according to IRB and protocol guidelines.?Depending on study, may implement a system for obtaining, labeling, processing and shipping specimens through the lab and hospital units. ·
Submits required documentation to IRB including opening/closing of studies, informed consent documents, and amendments and renewals of study protocols.
Assists Principal Investigator in identifying potential sponsors/studies. ·
Responsible for study drug/device accountability, including ordering study drugs/devices, distribution and/or administration of study drugs/devices, and when appropriate, maintaining study drug/device accountability records and returning unused study drug/device to sponsor.????
Bachelor's degree in nursing, biomedical or healthcare related field or Bachelor's Degree in unrelated field with relevant research experience. ·
Active California RN license; Certified Clinical Research Professional (CCRP), Certified Research Coordinator (CRC), or Certified Clinical Research Coordinator (CCRC) preferred
Excellent communication and writing skills. General office equipment and computer skills, including MS Office. ·
Familiarity with HIPAA regulations and regulations governing human subjects in research. Demonstrated knowledge and understanding of the IRB process. Working knowledge of scientific and medical concepts and terminology, and strong familiarity with biomedical research protocols.