Job Title

Position Details Expiration Date Open Until Filled Department CA Human Subjects Rsrch Supprt Position Type Professional Location Shreveport Description Clinical Trials Office (CTO) is an institutional resource established to assist institutional Clinical Research Investigators in the conduct of Clinical Trials. Clinical coordinator support is provided to the Investigator by providing Clinical Research Coordinators (CRC) with a broad base of experience in patient care; knowledgeable of the disease process, illnesses, injuries; and knowledgeable regarding the research process and the conduction of clinical trials, the applicable federal and state regulations, and institutional policies. The CRC must be proficient in performing technical aspects of patient care and the conduction of research procedures and processes in accordance with the federal, state and institutional requirements. CRC care is provided in conformance with research nursing and legal standards and in conjunction with hospital and nursing policies and procedures. The incumbent may rotate among various clinical trials and may rotate/extend assigned hours to accommodate increased patient census, acuity level, and/or to provide coverage for call-ins, etc. This is a professional nursing position that operates within a highly clinical, educational and research-based environment, and interacts largely with clinical and professional individuals. This position requires a nurse who works independently and completes tasks without close supervision. The role of this position is to provide continuity of care for subjects involved in research studies in a variety of patient localities and situations, and to supervise other research personnel involved in the research process. The incumbent must be flexible to meet the varied demands of multiple departments within LSUHSC-Shreveport, which necessitate the assistance of a research coordinator to conduct clinical trials. This professional nurse will work with a variety of disease processes and therefore requires an advanced individual, knowledgeable of the medical field. Level of responsibility involves performance and supervision of clinical drug or device studies and implementation of protocols for clinical care procedures and research observations. The incumbent of the position must utilize organizational skills and requires the ability to comply with guidelines and regulations of clinical drug studies. The position requires proficiency in the collection of data and compilation of reports. The incumbent should demonstrate initiative and ability to organize and plan for a productive workload, efficient time of patient management and record keeping. Regular attendance is required to perform the functions of this position. Normal work hours are 8:00AM to 4:30PM, Monday through Friday. Additional hours may be required, including weekends and before/after-hours work. Lunch and other breaks must be flexible and are dictated by the workflow. Incumbent will maintain a customer-oriented awareness in acknowledging and responding to needs as they occur that customer satisfaction is met at all times. Essential Position Functions & Duties 95% Essential Functions * Coordinates trials in accordance with established protocols, ICH Guidelines, FDA Regulations, Good Clinical Practices, institutional policies, and ethical clinical practice. * Performs RN duties related to investigational products (drugs, biologics, devices, etc.) * Monitors and assesses the effect of the investigational products. * Administers research products including highly specialized therapy, utilizing complicated medical equipment competently and safely. * Assesses equipment/devices (spirometers, EKG machines, blood glucose monitors, defibrillator, etc.) for proper functioning according to protocol. * Provide emergency care in life threatening situations. * Determine subject's clinical protocol eligibility in coordination with the principal investigator. * Assist with necessary staff in-service training and protocol training. * Communicates protocol needs to other departments. * Interacts with subjects directly during visits or by phone. * Maintains research supply inventory. * Maintains emergency equipment and supplies in good working order. * Willingness and ability to travel to the sponsor's investigator meetings or trainings. * Maintains strict confidentiality in compliance with the Health Insurance Portability and Accountability Act (HIPAA). * Have the appropriate communication skills that further the goal of information sharing, knowledge and responsibilities of the study with the principal investigator, other research team members including clinical trial sponsors, any of their contracted associates, and all applicable regulatory agencies. * Prepares and submits regulatory documents as necessary for the clinical trials to include SAEs, Safety Reports, and IRB submissions. * Complete yearly training for clinical research efforts through the training portal CITI. * Responsibly transport and store biomedical waste in accordance with federal, state, and university policies. * Collects or supervises data collection for study documents. * Analyzes and evaluates clinical data and reports it appropriately. * Develops and maintains organized record files. * Maintain certification for handling hazardous waste disposal through the Office of Safety Services. * Maintain yearly certification and procedures. Non-Essential Position Functions & Duties 5% Marginal Functions (5%) * Performs other related duties and responsibilities as assigned. Qualifications The applicant must meet one of the following: * Master's (MSN) or bachelor's (BSN) degree in nursing from an accredited nursing program with two (2) years of experience in a clinical and/or research setting. Must possess a valid Louisiana license to practice professional nursing. * Associate Science Nursing (ASN) from an accredited nursing program with a minimum of three (3) years of experience in a clinical and/or research setting. Must possess a valid Louisiana license to practice professional nursing. Preferred Qualifications * Experience in coordinating clinical trials or practicing in a research setting. * Certified Clinical Research Coordinator (CCRC) credentials. * Experience working as a nurse in an ICU or ER setting. Additional Position Information PSN/PER Number: PSN 54724/PER 2491 Salary Range: $60,000 - $80,000 Primary Location: Shreveport, LA (on-site position) About the School The LSU Systems Office has provided LSU Health-Shreveport employees with excellent benefit options designed with you and your dependents in mind. Our Benefits Section is available between 8:00 a.m. and 4:30 p.m., Monday through Friday, to help answer any questions you might have about these benefits. * Salary is commensurate with experience and training * Generous Health, Dental, and Vision Insurance * Life Insurance * Long-Term Disability Insurance * Accidental Death & Dismemberment Insurance * Flexible Spending Account * Optional Retirement Plans LSU Health is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. Applicant Instructions Locate and click on the Apply Online button located at the bottom of the screen, enter your contact information, and upload your resume/CV. If you need assistance applying electronically, please telephone 318-675-5589. If you are contacted for an interview, please let us know at that time if you will need special accommodations. Apply Online LSU Health is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law.LSU Health Shreveport has a goal of having at least 7% of our workers as people with disabilities.