We are seeking a CO Sr. Research Nurse to Report to the Senior Division Manager, Nurse Manager and or the Lead Research Nurse, this position is responsible for the coordination and implementation of assigned clinical trials within the research program.
Specific Duties & Responsibilities
Collaborates in development and preparation of regulatory documents as appropriate including consent templating, eligibility checklist, PK/VS/EKG sheets.
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.
Obtains appropriate data base/electronic data capture training and access.
Oversees & collaborates in development of study tools including data collection forms, eligibility checklists, Beacon orders, & distribution of the protocol on the Web Library and Internet (where applicable)
Sets up/assures set up of appropriate research study accounts/ reviews PRA.
Assures receipt of protocol and other manuals/documents to clinical CORES for review & input as appropriate.
Assures study documents are uploaded into PRL website for Beacon Treatment Plan development for both new submissions and amendments.
Assures compliance with local & national regulatory standards; as appropriate, prepares & submits required regulatory documents.
May participate in drug data sheet development/review/revision.
Monitors for IRB approval/request for further information as appropriate.
Determines that IRB approval has been received and study status is Active on CRO protocol library prior to initiation of research activity.
Represents department at research, investigator and protocol initiation meetings as required.
Assures that all elements of a trial are in place before opening to accrual.
Communicates with protocol sponsors, NCI, cooperative group and may coordinate plans to address issues with PI.
Recruitment & enrollment
Ensures initial & ongoing eligibility of all subjects for assigned research studies.
Collaborates in the development of recruitment strategies to ensure patient accrual within protocol time frames.
Data collection/Document Maintenance
Applies pharmacological knowledge to assist the investigator in determining adverse event causality & relationship to study drug/procedure.
Assures accurate recording & documentation of 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.
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.
Participates in sponsor/cooperative group/internal audits/monitoring.
Assures correspondence of faxes, e-mails, IRB/JCCI submissions, FDA submissions, etc. are in the regulatory binder/files.
Communicates effectively with study team members, CORES, clinical staff, patients and families.
Designs/coordinates educational education and tools for patients and families relevant to protocols.
Provides ongoing education to patients and families regarding pertinent clinical trial procedures and management of clinical care.
With assistance, coordinates and/or presents continuing education/in-service programs for Clinical Research Nurses, Clinical Nurses, Clinical Associates, Study Coordinators, Research/Standard of care Phlebotomists, and any 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.
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 and clinical care for assigned clinical trials.
Begin to manage multi-modality trials utilizing current treatment modalities.
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 and protocol requirements.
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.
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 year's experience in the specialty or a related are 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 Job Posting Title (Working Title): CO Sr. Research Nurse Role/Level/Range: ACRP/04/MF Starting Salary Range: Min $74,400 - Max $130,400 Annually; Commensurate with experience) Employee group: Full Time Schedule: M-F, 830a - 500p Exempt Status: Exempt Location: School of Medicine Campus Department name: SOM Onc Hematologic Malignancies Personnel area: School of Medicine
Total Rewards The referenced salary range is based on Johns Hopkins University's good faith belief at the time of posting. Actual compensation may vary based on factors such as geographic location, work experience, market conditions, education/training and skill level. Johns Hopkins offers a total rewards package that supports our employees' health, life, career and retirement. More information can be found here: https://hr.jhu.edu/benefits-worklife/
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. Johns Hopkins is committed to hiring individuals with a justice-involved background, consistent with applicable policies and current practice. A prior criminal history does not automatically preclude candidates from employment at Johns Hopkins University. In accordance with applicable law, the university will review, on an individual basis, the date of a candidate's conviction, the nature of the conviction and how the conviction relates to an essential job-related qualification or function.
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.
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. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit accessibility.jhu.edu.
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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Johns Hopkins University remains committed to its founding principle, that education for all students should be grounded in exploration and discovery. Hopkins students are challenged not just to learn but also to advance learning itself. Critical thinking, problem solving, creativity, and entrepreneurship are all encouraged and nourished in this unique educational environment. After more than 130 years, Johns Hopkins remains a world leader in both teaching and research. Faculty members and their research colleagues at the university's Applied Physics Laboratory have each year since 1979 won Johns Hopkins more federal research and development funding than any other university. The university has nine academic divisions and campuses throughout the Baltimore-Washington area. The Krieger School of Arts and Sciences, the Whiting School of Engineering, the School of Education and the Carey Business School are based at the Homewood campus in northern Baltimore. The schools of Medicine, Public Health, and Nursing share a campus in east Baltimore with The Johns Hopkins Hospital. The Peabody Institute, a leading professional school of music, is located on Mount Vernon Place in downtown Bal...timore. The Paul H. Nitze School of Advanced International Studies is located in Washington's Dupont Circle area.