Johns Hopkins University Research Nurse Manager in Baltimore, Maryland
The Division of Cardiology is seeking a Research Nurse Manager . Approximately fifty percent of this individual’s effort will be devoted to cardiac catheterization-based clinical research working under the direction of Dr. Jon Resar. The rest of this individual’s effort will be devoted to the overall management and participation in the shared Cardiology clinical research personnel and resources under the direction of Dr. Thorsten Leucker. The latter will include identifying, developing, participating in, implementing and evaluating effective shared clinical research management strategies. This role reports to Drs. Jon Resar and Thorsten Leucker.
Specific Duties & Responsibilities:
Clinical Research Manager Role Responsibilities:
Assist in the recruitment and training of shared clinical research personnel (research coordinators, technicians, and nurses).
Assess staff workload and determine assignments in coordination with PIs.
Assign clinical research duties to staff based on skill assessments, to optimize participant scheduling, research procedures, meetings with study monitors, and IRB, budget, and invoice preparations and monitoring. Research procedures may include phlebotomy, lab processing, performing ECGs, recruitment, scheduling, administering surveys, administering study medications, etc.
Perform clinical research tasks as needed for various research projects.
Oversee the utilization of shared resources, such as space, equipment and items for biospecimen processing and storage.
Manage research staff hired in the shared clinical research program and facilitate performance appraisals.
Organize and conduct periodic meetings with clinical research personnel to review procedures and challenges. Arrange for outside presentations from Office of Research Administration and other personnel regarding grant and budget preparations, regulatory issues, and other School of Medicine initiatives relevant to cardiology clinical research.
Periodic meetings with PIs utilizing the shared personnel and resources to review priorities, personnel performance, needs, and suggestions for improvements.
Maintain an “up to date” listing of ongoing research, the PIs, and coordinators/nurses on those projects and the termination dates for the supporting grants and contracts in collaboration with the cardiology grants/contracts team. Coordinate a list of investigators who require additional coordinator/nurse support at present or anticipate needing someone in the future.
Assist PIs with clinical protocol development, including reviewing and assessing new protocols for clarity, thoroughness, logistical feasibility, maintaining subject safety, etc.
Work with research coordinators, inpatient/outpatient nurses, research nurses, research nurse leads, research pharmacy, and other research cores to optimize the practical implementation of clinical research studies.
Work closely with other Clinical Research Program Managers within the Department of Medicine to help create effective, efficient research systems, and avoid duplication of effort.
Work with the clinical research leadership team and cardiology administration to develop a cost structure for faculty use of shared clinical resources.
Prepare invoices for cost transfers for use of shared clinical research resources.
Meet regularly with the clinical research faculty leadership with updates on successes and challenges in building the shared resource program.
Catheterization Clinical Research Nurse Responsibilities:
Manage and coordinate care of Cardiology patients participating in designated catheterization --based clinical trials under the direction of the Principal Investigator.
Anticipate requirements for designated patient populations; screen potential research subjects for participation in catheterization clinical trials and evaluate ongoing eligibility of research subjects.
Ensure collection of pertinent data and 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).
Monitor compliance with requirements of assigned clinical trials and resolve queries and review monitoring reports to identify and correct deficiencies.
Ensure that patients and staff education needs are met with regard to assigned protocols.
Report protocol deviations and adverse events in a timely manner.
Responsible for patient follow-up and collection of specimens.
List and clarify concern and questions about new protocols with PI/ sponsors.
Propose and negotiate alternatives to improve protocol implementation.
Review and assesses new protocols for clarity, thoroughness, logistical feasibility, maintaining subject safety, etc.
Represent catheterization-based projects at research and protocol initiation meetings
Applies cardiology device and pharmacological knowledge to assist investigators in determining adverse event causality and relationship to study drug / device and study procedures.
Maintain study inventory according to regulatory standards.
Review with PIs research accounts status.
Work with Compliance Committees and Institutional Review Boards.
Collaborate with multidisciplinary teams, other research coordinators, 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 research studies. Set up databases, 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.
Participate in periodic research conferences.
Conduct all study close out related procedures including IRB termination reports.
This description is a general statement of required duties and responsibilities performed on a regular and continuous basis. It does not exclude other duties as assigned.
Minimum Qualifications (Mandatory):
Individual must be a registered nurse, licensed in the State of Maryland.
Bachelor's Degree in Nursing or related discipline required.
Minimum of five (5) years experience in the specialty or a related area required.
Five years of related clinical nursing research experience required.
Related Master's Degree may be considered in lieu of some experience, to the extent permitted by the JHU Equivalency formula.
Extensive experience with clinical research sciences, regulatory affairs; Extensive experience with protocol and informed consent writing; Prior experience managing clinical research staff required.
Licensure, Certification, Registration:
Licensed Registered Nurse in the State of Maryland.
Current CPR certification required.
Must maintain current licensure and certification during duration of employment.
Special Knowledge, Skills & Abilities:
Able to manage and supervise others
Collaborates effectively in a team environment
Adapt to changing priorities
Excellent oral and written communication
Cardiology experience preferred.
IRB preparation experience
Clinical research experience
Skills Acquired During “Probation” Period
Taking all required Epic classes for coordinator role
Sending biospecimens to core, and other, laboratories
REDCap data entry
Entering notes into Epic
Retrieving data from Epic
JHU Equivalency Formula: _ 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for the required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job._
Classified Title: Research Nurse Manager
Starting Salary Range: $83,150 - $114,320 annually (commensurate with experience)
Employee group: Full Time
Exempt Status: Exempt
Location: School of Medicine Campus
Department name: SOM DOM Cardiology
Personnel area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the HR Business Services Office at email@example.com . For TTY users, call via Maryland Relay or dial 711.
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The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.
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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Johns Hopkins University is an equal opportunity employer and does not discriminate on the basis of race, color, gender, religion, age, sexual orientation, national or ethnic origin, disability, marital status, veteran status, or any other occupationally irrelevant criteria. The university promotes affirmative action for minorities, women, disabled persons, and veterans.