TheClinical Research Nurseindependently manages operations of one or more research studies or clinicaltrial protocols for the Department ofAnesthesiology which require the expertise and care of a Registered Nurse.The Clinical Research Nurse instructs and counsels patients in researchprocedures, administers treatment procedures, monitors patients duringprocedures, and analyzes patient data. The position also serves as the primaryliaison to other departments, outside organizations, government agencies, andproduct representatives to promote effective and efficient operation and use ofresources. The Clinical Research Nurse provides guidance and direction topersonnel engaged in clinical research or trials to ensure compliance withprotocols and overall clinical objectives.
TheDepartment of Anesthesiology is located at the University of Maryland,Baltimore School of Medicine. The mission of the Department of Anesthesiologyis to deliver state-of-the-art anesthesia services in perioperative care, painmanagement and critical care; educate students, residents and fellows; berecognized for its contributions to the specialty of anesthesiology througheducation, research and scholarly activities; and contribute to the success ofthe Medical School and Medical System.
Developsand tracks work flow policies, recruitment strategy, and progress through theduration of the research study or clinical trial. Collaborates with PrincipalInvestigators and regulatory staff in the preparation of new protocolsubmissions, protocol amendments, and renewals of ongoing clinical trials.
Managesinteraction with subject participants including eligibility screening,recruitment, enrollment, ensuring informed consent is properly secured anddocumented, counseling, and obtaining patient medical history.
Managespatient care in compliance with the research study or clinical trial protocolrequirements. Monitors subject condition while ensuring safety and maintainingconfidentiality. Identifies patient problems and makes adjustments to careplans.
Servesas a patient advocate throughout the research study or clinical trial. Developsand conducts patient and family education.
Administerand implement treatment procedures or drugs, monitors and studies their effects,and conducts subject medical evaluations.
Monitorsactivities to ensure compliance with protocols and all relevant local, federal,and state regulatory and institutional policies. Continuously educates andtrains personnel on compliance and protocol. Identifies protocol problems,informs investigators, and assists in problem resolution efforts.
Managescomplex research study or clinical trial data. Develops methods for collection,database storage, tracking, analysis, and interpretation of data.
Developsand prepares study or research related documentation such as protocolworksheets, procedural manuals, adverse event reports, case report forms, andinstitutional review board documents. Responsiblefor developing and producing custom and routine reports. Provides expertise in identifying andwriting research grants, publications in medical and nursing literature, studymaterials, brochures, and correspondence.
Reviewsproposed research study and clinical trial protocols to evaluate factors suchas sample collection process, facility location, data management plans, andpotential subject risks. Conducts quality assurance audits on data andregulatory documentation. May identify potential research study and clinicaltrial opportunities.
Obtainstissue and blood samples as necessary and collects information throughinterviews, questionnaires, test results, and charts.
Attendsresearch study or clinical trial related meetings, conferences andteleconferences, as well as participating in any additional planning anddevelopment related activities.
Providesongoing training and guidance to less experienced research and nursingpersonnel.
Performs other related duties asassigned.