Baltimore , MD
Job posting number: #7083618
Posted: August 23, 2021
Application Deadline: Open Until Filled
Job DescriptionGeneral Summary/Purpose:
Research Nurse coordinates day to day tasks related to designing, implementing and/or completing clinical research projects. Ensures the implementation of research protocols as well as ongoing administrative processes related to these studies; screen and enroll patients, and provide continued monitoring of these studies ensuring that all protocols are followed and status reporting, billing, and other regulatory components are performed correctly.
Will manage and coordinate care of Cardiology patients participating in designated clinical trials under the direction of the Principal Investigator.
Anticipates requirements for designated patient populations; screens potential research subjects for participation in clinical trials and evaluates ongoing eligibility of research subjects.
Ensures collection of pertinent data and will be responsible for all data management (i.e. entering data into sponsor database(s) and maintaining individual participant’s binders from internal and external sources).
Monitors compliance with requirements of assigned clinical trials and resolves queries and reviews monitoring reports to identify and correct deficiencies.
Ensures that patients and staff education needs are met with regard to assigned protocols. Reports protocol deviations and adverse events in a timely manner.
Responsible for patient follow-up and collection of specimens.
Lists and clarifies concern and questions about new protocols with PI/ sponsors. Proposes and negotiates alternatives to improve protocol implementation. Reviews and assesses new protocol for clarity, thoroughness, logistical feasibility, maintaining subject safety, etc. represents department at research and protocol initiation meetings, applies cardiology device or pharmacological knowledge to assist the investigator in determining adverse event causality and relationship to study drug / device procedure.
Maintains study inventory according to regulatory standards. Reviews with PIs research accounts status. Works with Compliance committees and Institutional Review Boards.
Collaborates with multidisciplinary teams. Will work with Regulatory Research Coordinator and Commercial sponsors.
Handle relevant patient biological specimens and follow protocol requirements.
Blood sample processing to include obtaining specimens by phlebotomy and appropriate handling and labeling.
Oversee record management for several research studies. Set up database, as well as processing systems and efficiencies for reporting purposes using Excel, Access, or similar systems
Oversee budget development, as well as budget expenditures for study operations. Lead and Participate in weekly research conferences.
Conduct all study close out related procedures including IRB termination reports
Must be a registered nurse, licensed in the State of Maryland or state where practicing required.
Current CPR certification required.
Must maintain current licensure and certification during duration of employment.
Successful completion of the JHH credentialing process is required prior to start date.
Bachelor's degree in nursing or related discipline preferred.
Research nursing experience preferred.
Classified title: Research Nurse
Working title: Research Nurse
Role/Level/Range: ACRP 37.5/E/03/ME
Starting Salary Range: $60,945 - $83,865 (commensurate with experience)
Employee group: Fulltime
Employee Status: Exempt
Schedule: Monday-Friday – 8:30am-5:00pm 37.5hrs/Wk
Location: 600 N Wolfe St., Baltimore, MD
Department name: 10002805-SOM DOM Cardiology
Personnel area (School): SOM – School of Medicine