The Senior Research Nurse is responsible for the coordination and implementation of assigned clinical research trials within the Upper Aerodigestive Cancer Program.
Specific Duties & Responsibilities
Anticipates research requirements for designated patient populations.
May collaborate 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.
Evaluates the impact on & availability of resources for assigned clinical trials.
Lists & clarifies concerns & questions about new protocols with PI &/or sponsor Proposes & negotiates alternatives to improve protocol implementation.
Collaborates in the determination of roles & responsibilities of health care team members in the implementation of assigned trials.
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).
Assists with preparation of budget for submission and coordinates study sponsor contract designation as appropriate.
Provides copy of study and pre-printed data forms to Data Management office for review and approval as appropriate.
Prepares GCRC and PCRU protocol submissions as appropriate.
Assures receipt of protocol by pharmacy for review & input as appropriate.
Communicates with coordinating center and provides necessary documentation (i.e., CVs, 1572, lab licenses, normal values, IRB submissions, etc.) as appropriate.
Assures compliance with local & national regulatory standards; as appropriate, prepares & submits required regulatory documents.
Prepares drug data sheets for pharmacy and assures submission of same to CRO/IRB for assigned protocols as appropriate.
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 opening to accrual.
Communicates with protocol sponsors, NCI, cooperative group and coordinates plans to address issues with PI.
Recruitment & Enrollment
Ensures initial & ongoing eligibility of all subjects for assigned research studies, Same as Level I.
Collaborates in the development of recruitment strategies to ensure patient accrual within protocol timeframes.
Data collection/Document maintenance.
Ensures collection of pertinent data from internal & external sources & monitors compliance with requirements of assigned clinical trials.
Applies pharmacological knowledge to assist the investigator in determining adverse event causality & relationship to study drug/procedure
Records & documents protocol deviations.
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 study team 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 institutional SOPs pertaining to performance of clinical research.
Maintains records of correspondence of faxes, e-mails, IRB/JCCI submissions, FDA submissions, etc.
Designs/coordinates educational programs for patients and families relevant to protocols.
Provides ongoing education to patients and families regarding pertinent clinical trial and clinical management issues.
Participates in orientation process for new Clinical Research Nurses and Clinical Associates, including mentoring and precepting.
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.
Identifies need and incorporates information from other health care disciplines into clinical research protocol.
Plans long-term study patient care in relation to identified and potential problems related to assigned research protocols/patient populations.
Collaborates with health care team to coordinate and facilitate protocol requirements for assigned clinical trials.
Evaluates the effectiveness of nursing care s/he has planned, administered, or delegated.
Evaluates patient's response to interventions outlined on study protocol.
Proposes alternative methods to meet individual patient needs.
Evaluates effectiveness of nursing care planned on a long-term basis.
Gives rationale for action/inaction based on scientific principles, practice experience, and internal/external regulations.
Evaluates patients participation in assigned clinical trials and identifies barriers to compliance.
Plans, proposes and evaluates means to overcome identified barriers to protocol compliance.
Develops and maintains collaborative relationships with members of other health care disciplines in order to facilitate clinical and research outcomes.
Provides guidance and direction to other health care professionals (internal and external) in implementation of research protocols.
Evaluates effectiveness of collaborative role with other health care professionals.
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.
Additional experience may substitute for bachelor's degree and related master's degree may be considered in lieu of experience.
Classified Title: Sr. Research Nurse Role/Level/Range: ACRP/04/MF Starting Salary Range: 72,940 - $100,380 (Commensurate with experience) Employee group: Full Time Schedule: M-F 8am- 4:30pm Exempt Status: Exempt Location: Hybrid/School of Medicine Campus Department name: SOM Onc Upper Aerodigestive Cancer Personnel area: School of Medicine
Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines:
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 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.
The successful candidate(s) for this position will be subject to a pre-employment background check.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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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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