Job DescriptionJob Overview:Acts as the clinical research nurse for research studies in which TriHealth participates. Acts as a liaison between Study Sponsors, Study Monitors, Principal Investigators, other physicians, hospital staff, and the Institutional Review Board (IRB) to coordinate the efforts necessary to efficiently and effectively conduct a clinical research study. Actively participate in the selection of studies TriHealth conducts, developing a process for implementation of the protocol, participating in the identification of potential subjects, participating in the informed consent process, enrolling subjects and accurately and thoroughly collecting and reporting data. Educates and coordinates the care of patients who are on research studies. Staff in this position have the ability to work at all sites where research is conducted within TriHealth. Travel between sites may be required. Staff in this position may be required to work in other research specialties other than the one for which they are hired. Staff in this position must be available to cover the needs of the department which may be 7am-7pm. Staffing needs and hours are determined by amount and kind of studies the department has at any given time.Job Requirements:Bachelor's Degree in NursingEquivalent experience accepted in lieu of degreeBasic Life Support for Healthcare Providers (BLS)Clinical Research Coordinator Certification after 2 years of Fulltime research experienceRegistered NurseProficient in Microsoft Office programsKnowledge of clinical research2-3 years experience Clinical Nursing Critical thinkingJob Responsibilities:Demonstrates the ability to develop processes to facilitate implementation of the research protocol to provide effective and safe medical research to all subjects. Demonstrates the ability to identify potential and/or actual issues, which may prohibit the accurate implementation of the research protocol and initiate interventions to avoid protocol violations and/or unsafe practice. Demonstrates the ability to coordinate necessary activities between the Study Coordinators and the Principal Investigator.Performs initial and ongoing assessments of research subjects and implements care directed towards optimal outcomes. Plans care for research subjects/families based on assessment, standards of care, optimal outcomes and protocol requirements. Implements and evaluates plan of care. Performs technical skills according to policy and procedure and accepted TriHealth Standards. Documents in medical records appropriately.Complies with all IRB/FDA requirements in study submissions. Assures compliance with IRB/FDA standards and deadlines in notification of subject randomization and enrollment. Assures compliance with IRB/FDA standards and deadlines in completing Progress Reports. Assures compliance with IRB/FDA standards and deadlines in reporting all deaths and adverse events with in study subjects. Assures compliance with IRB/FDA standards and deadlines in facilitating communication between study sponsor and designated IRB.Appropriately and accurately assesses potential subjects for inclusion and exclusion criteria. Keeps Case Report Forms complete and thorough using the IRB and FDA standards. Supports hospital staff in complying with research protocols and works to minimize the impact on their workload. Keeps queries and protocol violations that can be controlled to a minimum. Responds appropriately and accurately to all queries in a timely fashion.Demonstrates knowledge of available studies, screening potential patients for eligibility, guiding physicians and staff in needed timetables for appropriate randomization. Participates in the identification and selection of good clinical protocols based on subject selection, safe medical practice and resource availability. Attends training required by sponsoring organizations for specific protocols and/or attends meetings related to the initiation or on-going progress of a sponsored clinical trial. Acts as the point person for audit staff coming into institution for a review, prepares a written response with a plan of action to any major/minor deficiencies.Other Job-Related Information:Working Conditions:Climbing - OccasionallyConcentrating - FrequentlyContinous Learning - FrequentlyHearing: Conversation - ConsistentlyHearing: Other Sounds - FrequentlyInterpersonal Communication - ConsistentlyKneeling - OccasionallyLifting About UsCareers at TriHealth are diverse. From clinical to administrative, sales to service, our team members contribute skills that are as varied as the services we offer and the people we serve. As an employer, TriHealth demonstrates the organization's values by offering comprehensive benefits packages, competitive wages, and milestone recognition.Explore our career options to help you determine the type of job best for you as well as help narrow your search within our website. We look forward to you joining the TriHealth family!About the TeamNurses are at the heart of patient care, and we are proud to have such amazing nurses here at TriHealth. As the region's leading health system, we are focused on consistency in the patient experience and standardizing nursing care across the system with proven best practices. We aim to continue leading research supporting the evolution of nursing care, especially as TriHealth works to adapt the population health model system-wide.In order to lead these changes, TriHealth must invest in our nurses, which is why we provide multiple opportunities for nurses to achieve their professional development goals through tuition reimbursement programs, specialty certifications and several other continuing education opportunities. Our registered nurses support TriHealth in many different aspects of nursing, including patient care, care coordination, education and management.If you're interested in joining our world-class nursing team, you can see all current nursing opportunities here on TriHealth.com.I am honored to lead our TriHealth nursing team, and welcome you to join us!#J-18808-Ljbffr

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