Research - Laboratory/Non-Laboratory, Staff/Administrative
The Transplant and Oncology Infectious Diseases (TOID) Clinical Research Center (CRC) is currently seeking a Research Nurse to implement and oversee multiple single center and multi-site national studies as assigned for the division of Transplant Oncology and Infectious Disease (TOID). Our primary research is related to the prevention and treatment of infectious complications in the immunosuppressed population, particularly solid organ and bone marrow transplant patients. The Research Nurse should be someone who works well in a fast-paced collaborative atmosphere but can also maintain a high degree of independence. The successful applicant will be passionate about improving the long term trajectory for those participants through research and clinical care. This position will report directly to the TOID CRC Senior Research Nurse, the Lead CRC Supervisor, and the TOID CRC Program Manager.
Duties and Responsibilities
Anticipates research requirements for designated patient populations.
May collaborate in development and writing of protocols and consent forms, as appropriate.
Collaborates in development and preparation of regulatory documents and IRB submissions, as appropriate.
Reviews and assesses new protocols for clarity, thoroughness, logistical feasibility, maintaining subject safety, etc. for assigned protocols.
Lists and clarifies concerns and questions about new protocols with Sr. Research staff and PI.
Proposes and negotiates alternatives to improve protocol implementation.
Collaborates in the design of appropriate methods for collection of data required for assigned trials.
Develops study tools including data collection forms, eligibility checklists, tracking logs, etc.
Ensures compliance with local and national regulatory standards.
Collaborates with study team and pharmacy to prepare drug data sheets for new trials.
Monitors for and notifies PI of IRB approval/request for further information.
Represents department at research and protocol initiation meetings.
Ensures that all elements of a trial are in place before opening for accrual.
Participates in communications with protocol sponsors, and cooperative group, and coordinates plans to address issues with PI.
Recruitment & enrollment:
Collaborates in the development of recruitment strategies to ensure participant accrual within protocol timeframes.
Data collection/Document maintenance:
Ensures collection of pertinent data from internal and external sources, and monitors compliance with requirements of assigned clinical trials.
Ensures all protocol deviations are communicated to study team for proper documentation and/or submission to regulatory agencies.
Performs or schedules study-related tasks and procedures, such as investigational product administration/dispensation, phlebotomy, blood processing and shipping, urine collection, and vital signs, as outlined by the study protocol.
Evaluation and Oversight:
Manages participants on clinical studies while adhering to all protocol mandates.
Coordinates with clinical teams to ensure adherence to standard of care clinical practice. Evaluates participant's response to interventions/study medications, including toxicities, dose modifications, dose levels, adverse reactions; proposes alternative methods to meet individual participant needs.
Applies clinical/pharmacological knowledge to assist the investigator in determining adverse event causality and relationship to study drug/procedure.
Evaluates participant's participation in assigned clinical trial and identifies barriers to compliance.
Plans, proposes, and evaluates means to overcome identified barriers to protocol compliance.
Gives rationale for action/interaction based on scientific principle, practice experience, and internal/external regulation.
Oversees the preparation of orders by physicians to ensure protocol compliance is maintained, and submits orders to obtain clinical research samples as outlined in the protocol.
Educates participants and families on protocol structure, study procedures, and study medication, ensuring understanding and adherence.
Participates in the informed consent process.
Monitors study team compliance with required study procedures and GCP standards.
Assumes responsibility for specific QA activities for research teams (i.e., participates in institutional QA process).
Participates in sponsor/cooperative group/internal audits and monitoring.
Assists with development and review of TOID SOPs pertaining to performance of clinical research.
Maintains records of correspondence (faxes, e-mails, IRB submissions, FDA submissions, etc.).
Demonstrates ability to manage multiple projects at different stages of the clinical research process.
Demonstrates ability to integrate new clinical trials with current research activity.
Collaborates with other members of the research team in preparing study results for presentation/publication.
May have opportunity to author/coauthor manuscripts for publication and/or presentation at conferences related to areas of expertise.
Individual must be a registered nurse, licensed in the State of Maryland or state where practicing. Bachelor's degree in nursing or related discipline required.
Minimum of two years' experience in nursing 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 or BMC credentialing process is required within two weeks of start date.
Classified Title: Research Nurse Working Title: Research Nurse Role/Level/Range: ACRP/03/ME Starting Salary Range: $60,945.00 - $83,865.00 Employee group: Full Time Schedule: M-F 8:30-5pm Exempt Status: Exempt Location: 04-MD:School of Medicine Campus Department name: 10002813-SOM DOM Infectious Disease 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 firstname.lastname@example.org. For TTY users, call via Maryland Relay or dial 711.
The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.
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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