The University of Maryland, Baltimore (UMB), Department of Medicine, Division of Nephrology is currently seeking a Part-Time Clinical Research Nurse. The person in this position independently manages operations of one or more research studies or clinical trial protocols requiring the expertise and care of a Registered Nurse. Instructs and counsels patients in research procedures, administers treatment procedures, monitors patients during procedures, and analyzes patient data. 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. Provide guidance and direction to personnel engaged in clinical research or trials to ensure compliance with protocols and overall clinical objectives.
***This is a Part-Time [32 Hours Per Week] Position***
UMB offers a generous benefits package that includes 22 vacation days, 14 floating and holidays, 15 sick days; comprehensive health insurance and retirement options; and tuition remission for employees and their dependents at any of the University System of Maryland schools.
- 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.