Job Description:

Position: Oncology RN Research CoordinatorLocation: Lexington, KY - onsiteDuration: 6-month Contract to HireStart: ASAPResponsibilities:The Oncology Clinical Research Nurse (CRN) works with the Research Institute Market Clinical Research Manager (MCRM), Principal Investigators, co- and sub-investigators, clinical and ancillary departments, IRBs, and industry or government sponsors of research to plan, coordinate, implement and complete clinical trials and other research projects managed by the research institute.The incumbent has responsibility for the oversight of studies that explore complex medical diseases, which involve specialty and subspecialty expertise.She serves as clinical nursing knowledge role model in the care of research participants, performing clinical procedures and assessments of research participants that are appropriate within the RN scope of conjunction with the PI and other facilityclinic staff, she may provide direct patient care related to a research protocol.The incumbent independently manages all aspects of multiple clinical trials or other research projects as assigned, including but not limited to: research participant recruitment, screening and enrollment; completion of protocol required visits and procedures; collection and reporting of data; coordination of and participation in sponsor monitoring visits or federal audits; query resolution; adverse event reporting, source documentation and research record development and maintenance; study drug accountability; specimen collection, processing and shipmentThe incumbent works with the MCRM to ensure compliance of the research program and its studies with all applicable federal and state regulations, as well as the hospital's policies. This position will support the Oncology departments within the Kentucky marketThis position is responsible for maintaining quality standards for responsive service and professional documentation in compliance with hospital policies and procedures, and federal and state laws and regulations, all which is consistent with the Mission and Values of the hospital. This is an exempt position that may require occasional overnight travel and weekend assignments.(45%) DivisionSite Research OperationsPerform clinical assessments of research participants, including blood pressure, heart and respiratory rates, brief physical exams, EKGs, and other clinical testing appropriate within the RN scope of practice, i.e., NIH Stroke Scale, NYHA and CCS class.Perform clinical procedures per research protocols, including blood draws, injections, and other procedures appropriate within the RN scope of practice.Report change in research participant condition to PI and appropriate personnel in a timely manner.Perform timely and accurate collection and reporting of data in accordance with protocol and sponsor requirements, applicable laws, and institutional policies.Dispense study medication to research participants under the direction of the PI, andor coordinate study drug administration with hospitalclinic Pharmacy staff.Process labs for clinical trials, including collecting, centrifuging and aliquoting specimens, and ship specimens in accordance with federal biologics shipping regulations.Identify and report all unanticipated and other adverseserious adverse events, as well as protocol deviations, violations or exceptions, to the study sponsor and IRB as required by GCP, FDA, and OHRP.Conduct informed consent process with research participants; document informed consent discussion and obtain signatures per protocol, federal, state and institutional requirements.Coordinate all study-required visits, procedures, tests and activities to meet protocol requirements; schedule participant appointments with appropriate providerfacility.Prepare, manage and submit all required any required studyregulatory, documents, applications and forms, including but not limited to the applicable Institutional Review Board (IRB) application form(s), informed consent documents, 1572 forms, Conflict of Interest forms, and other forms as required by the sponsor, or IRB.Prepare for, coordinate and participate in sponsor monitoring visits or internalexternal audits; resolve queries and other findings promptly; prepare responses or corrective actions plans as needed.Determine effective strategies for promotingrecruiting research participants and retaining participants in long term clinical trials.To ensure protocol adherence, accurate data collection and billing compliance, instructadvise Principal Investigator (PI) and other health care providers in the hospital clinic setting as to protocol-required tests and procedures to be conducted at each visit.Qualifications: Required Education for Staff Job LevelsRequired Licensure and CertificationsCurrent RN license in state of employment requiredBLS certification requiredCurrent certification (CCRP or CCRC) by the Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) requiredMinimum 3 years of experience conducting clinical trials required; worked as primary research nurse for at least 5 drug or device trialsMinimum of 3 years of nursing experience with patients in a healthcare setting required, strongly preferably in oncologyThorough knowledge and understanding of research regulatory requirements involving human subjects research, including FDA, OHRP and GCP requirements requiredCurrent certificate of Human Subjects Protection and Good Clinical Practice training requiredExperience in implementation of research protocols and clinical trials processes requiredExperience in preparing and maintaining regulatory documents and other IRB-related study documentation requiredExperience with Microsoft Office software requiredLab processing experience requiredAbility to effectively present information and respond to common inquiriesAbility to write reports, business correspondence, and procedure manualsAbility to read analyze and interpret study protocols and accompanying materialsAbility to effectively communicate with respond to physicians, groups of peers, senior leadership, managers, etc.