Sr. Research Nurse
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:Pre-Study:
- 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
Recruitment & Enrollment:
- 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
Data Management/Document Maintenance:
- 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
- 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
Minimum Qualifications (Mandatory):
- 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.
* 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.
- 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.
Classified Title: Sr. Research Nurse
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.
Johns Hopkins has mandated COVID-19 and influenza vaccines, as applicable. Exceptions to the COVID and flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons. Requests for an exception must be submitted to the JHU vaccination registry. For additional information, applicants for SOM positions should visit https://www.hopkinsmedicine.org/coronavirus/covid-19-vaccine/
and all other JHU applicants should visit https://covidinfo.jhu.edu/health-safety/covid-vaccination-information/
.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.Equal Opportunity Employer
Note: Job Postings are updated daily and remain online until filled. EEO is the Law
To apply, visit https://jobs.jhu.edu/job/Baltimore-Sr_-Research-Nurse-MD-21205/884048900/
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