Job Description
Job 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 Nursing
Equivalent experience accepted in lieu of degree
Basic Life Support for Healthcare Providers (BLS)
Clinical Research Coordinator Certification after 2 years of Fulltime research experience
Registered Nurse
Proficient in Microsoft Office programs
Knowledge of clinical research
2-3 years experience Clinical Nursing Critical thinking
Job 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 - Occasionally
Concentrating - Frequently
Continous Learning - Frequently
Hearing: Conversation - Consistently
Hearing: Other Sounds - Frequently
Interpersonal Communication - Consistently
Kneeling - Occasionally
Lifting
TriHealth is an equal opportunity employer. We are committed to fostering a diverse and inclusive workforce.
