Analysis Skills, Biomedicine, Clinical Data, Clinical Practices/Protocols, Clinical Research, Clinical Study Publications, Clinical Support, Clinical Trial, Clinical Trial Management, Communications Protocols, Data Collection, Data Management, Defibrillator, Disease, Drug Development, Electrocardiogram, Emergency Care, Equipment Maintenance/Repair, FDA Requirements, Federal Laws and Regulations, File Maintenance, GCP (Good Clinical Practices), HIPAA (Health Insurance Portability and Accountability Act), Hazardous Materials Clean-Up, Hospital, ICH Regulations, Inventory Management, Investigational New Drug (IND), Legal Standards, Medical Equipment, Medical Treatment, Nursing, Organizational Skills, Patient Care, People Management, Record Keeping, Registered Nurse (RN), Research Administration, Research Nursing, Research Skills, State Laws and Regulations, University/School Policies, Willing to Travel
Clinical Trials Office (CTO) Position Description
Clinical Trials Office (CTO) Overview
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.
Key Responsibilities
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.
Work Environment and Flexibility
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.
Responsibilities and Duties
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.
Essential Position Functions & Duties
- 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 subjects 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 sponsors investigator meetings or trainings.
- Maintains strict confidentiality in compliance with the Health Insurance Portability and Accountability Act (HIPAA).
- 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
- Performs other related duties and responsibilities as assigned.
Work Schedule and Requirements
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. Regular attendance is required to perform the functions of this position.