The Clinical Research Nurse independently manages operations of one or more research studies or clinical trial protocols for the Department of Anesthesiology which require the expertise and care of a Registered Nurse. The Clinical Research Nurse instructs and counsels patients in research procedures, administers treatment procedures, monitors patients during procedures, and analyzes patient data. The position also serves as the primary liaison to other departments, outside organizations, government agencies, and product representatives to promote effective and efficient operation and use of resources. The Clinical Research Nurse provides guidance and direction to personnel engaged in clinical research or trials to ensure compliance with protocols and overall clinical objectives.
The Department of Anesthesiology is located at the University of Maryland, Baltimore School of Medicine. The mission of the Department of Anesthesiology is to deliver state-of-the-art anesthesia services in perioperative care, pain management and critical care; educate students, residents and fellows; be recognized for its contributions to the specialty of anesthesiology through education, research and scholarly activities; and contribute to the success of the Medical School and Medical System.
Develops and tracks work flow policies, recruitment strategy, and progress through the duration of the research study or clinical trial. Collaborates with Principal Investigators and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials.
Manages interaction with subject participants including eligibility screening, recruitment, enrollment, ensuring informed consent is properly secured and documented, counseling, and obtaining patient medical history.
Manages patient care in compliance with the research study or clinical trial protocol requirements. Monitors subject condition while ensuring safety and maintaining confidentiality. Identifies patient problems and makes adjustments to care plans.
Serves as a patient advocate throughout the research study or clinical trial. Develops and conducts patient and family education.
Administer and implement treatment procedures or drugs, monitors and studies their effects, and conducts subject medical evaluations.
Monitors activities to ensure compliance with protocols and all relevant local, federal, and state regulatory and institutional policies. Continuously educates and trains personnel on compliance and protocol. Identifies protocol problems, informs investigators, and assists in problem resolution efforts.
Manages complex research study or clinical trial data. Develops methods for collection, database storage, tracking, analysis, and interpretation of data.
Develops and prepares study or research related documentation such as protocol worksheets, procedural manuals, adverse event reports, case report forms, and institutional review board documents. Responsible for developing and producing custom and routine reports. Provides expertise in identifying and writing research grants, publications in medical and nursing literature, study materials, brochures, and correspondence.
Reviews proposed research study and clinical trial protocols to evaluate factors such as sample collection process, facility location, data management plans, and potential subject risks. Conducts quality assurance audits on data and regulatory documentation. May identify potential research study and clinical trial opportunities.
Obtains tissue and blood samples as necessary and collects information through interviews, questionnaires, test results, and charts.
Attends research study or clinical trial related meetings, conferences and teleconferences, as well as participating in any additional planning and development related activities.
Provides ongoing training and guidance to less experienced research and nursing personnel.
Performs other related duties as assigned.