We are currently seeking a Senior 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 use of novel organ sources to address the national organ shortage, such as HIV+ to HIV+ transplant under the HOPE Act. The Sr. Research Nurse/Project Manager should be someone who works well in a fast-paced collaborative atmosphere but can also maintain a high degree of independence. This position will report directly to the TOID Research Nurse Manager, Operational Manager, and Principal Investigator.
Specific Duties & Responsibilities:
Anticipates research requirements for designated patient populations
Collaborates in development & writing of protocols and consent forms, as appropriate
Collaborates in development and preparation of regulatory documents as appropriate
Applies knowledge of study design to evaluate new protocols
Applies knowledge of federal & local regulations when evaluating new protocols
Reviews & assesses new protocols for clarity, thoroughness, logistical feasibility, maintaining subject safety, etc. for assigned protocols
Collaborates in the determination of roles & responsibilities of research team members in the implementation of assigned trials
Evaluates the impact on & availability of resources for assigned clinical trials
Lists & clarifies concerns & questions about new protocols with Research Nurse Manager and PI
Proposes & negotiates alternatives to improve protocol implementation
Collaborates in the design of appropriate methods for collection of data required for assigned trials
Oversees & collaborates in development of study tools including data collection forms, eligibility checklists, preprinted orders, & distribution of the protocol on the Web Library and Internet (where applicable)
Develops study specific CRFs
Participates in the development of study specific databases, assuring clinical data is appropriate for answering study specific endpoints
Develops study specific laboratory and operational manuals
Oversees regulatory requirements are met for designated studies
Assures compliance with local, national, and international regulatory standards; as appropriate, prepares & submits required regulatory documents
Develop training materials for assigned studies/projects
Monitors for and notifies PI of IRB approval/request for further information as appropriate
Determines that IRB approval has been received prior to initiation of research activity
Represents department at research and protocol initiation meetings
Assures that all elements of a trial are in place before activating sites
Participates in communications with protocol sponsors, NCI, cooperative group and coordinates plans to address issues with PI
Recruitment & Enrollment:
Responsible for evaluating and assuring recruitment and study/project goals are met by the research team and participating sites.
Responsible for the development of recruitment strategies to ensure patient accrual within protocol timeframes
Prepares and presents study specific updates to Research Nurse Manager, Operations Manager, and Investigators as requested
Identify and provide recommendations to remediate issues of concern
Data Management/Document Maintenance:
Ensures collection of pertinent data from internal & external sources & monitors compliance with requirements of assigned clinical trials
Applies clinical/pharmacological knowledge to assure that safety reporting processes for assigned studies are implemented and maintained
Prepares and submits protocol amendments and revisions as appropriate
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
Evaluates outcomes of clinical trials
Monitors external sites compliance with required study procedures & GCP standards
Performs/monitors ongoing data analysis regarding clinical research studies, including toxicities, dose modifications, dose levels, adverse reactions, & response
Assumes responsibility for specific QA activities for research teams (i.e., participates in institutional QA process)
Participates in sponsor/cooperative group/internal audits/monitoring
Assists with development & review of TOID SOPs pertaining to performance of clinical research
Maintains records of correspondence of faxes, e-mails, IRB/JCCI submissions, FDA submissions, etc
Participates in orientation process for new Clinical Research Nurses and Clinical Research Coordinators, including the mentoring and managing of other clinic personnel to promote quality, safety, and excellence in care
Coordinates and/or presents continuing education/in-service programs for Clinical Research Nurses, Clinical Associates, Data Managers, and others involved in the research process
Attends and participates in in-service and external trainings, workshops, conferences, and other relevant programs for professional growth and development
Collaborates with other members of the research team in preparing study results for presentation/publication
Authors/coauthors manuscripts for publication in the nursing literature and/or presentation at conferences related to areas of expertise
Identifies nursing research questions related to protocol populations/issues and, with assistance, collaboration, and appropriate financial support, implements nursing research within departmental priorities
Takes advantage of opportunities to make presentations in local community regarding research projects, areas of expertise, etc.
Minimum Qualifications (Mandatory):
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. Master's Degree strongly preferred.
Minimum of two years' experience in the specialty or a related area required.
Minimum 2 years research experience.
Additional experience may substitute for Bachelor's Degree. Related Master's Degree may be considered in lieu of experience.
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.
* 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.
** Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.
Classified Title: Sr. Research Nurse Role/Level/Range: ACRP/04/MF Starting Salary Range: $71,510 - $98,410 annually (commensurate with experience) Employee group: Full Time Schedule: M-F 8:30-5pm Exempt Status: Exempt Location: Hybrid/School of Medicine Campus Department name: 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 Talent Acquisition Office at [email protected]. For TTY users, call via Maryland Relay or dial 711.
The following additional provisions may apply, depending on campus. 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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