The Department of Medicine, Division of Cardiology seeks a Research Nurse to manage and coordinate care of Cardiology/Electrophysiology patients participating in clinical trials under the direction of the Principal Investigator. 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.
Specific Duties and Responsibilities:
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
Individual must be a registered nurse, licensed in the State of Maryland or state where practicing. Bachelor's degree in nursing or related discipline preferred. Current American Heart Association or American Red Cross CPR certification required. Must maintain current licensure and certification during duration of employment. Acceptable completion of the JHH credentialing process.
Sitting, standing and walking for extended period. Reaching by extending hand(s) or arm(s) in any direction. Finger dexterity required to manipulate objects with fingers rather than with whole hand(s) or arm(s). Ability to move standard equipment through a hospital or clinical environment.
Classified Title:Research Nurse Role/Level/Range: ACRP/03/ME Starting Salary Range: $60,945.00 - $83,865.00; Commensurate with experience Employee Group: Full Time Schedule: Monday - Friday Exempt Status: Exempt Location: School of Medicine, East Baltimore Campus Department Name: Medicine, Division of Cardiology Personnel Area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
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During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.
The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.
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