The Department of Neurology, Neuromuscular Division is currently searching for a full time Nurse Practitioner to oversee the newly created ALS Multidisciplinary Clinic (ALS Association Sponsored). This position is responsible for the care of patients as well as coordination and implementation of ALS clinical trials.
Specific Duties and Responsibilities:
The Nurse Practitioner will participate in growing the ALS multidisciplinary clinic.
Identifies need and incorporates information from other health care disciplines into clinical 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 care s/he has planned, administered, or delegated
Proposes alternative methods to meet individual patient needs
Evaluates effectiveness of care planned on a long-term basis
Gives rationale for action/inaction based on scientific principles, practice experience, and internal/external regulations
Evaluates patient participation in assigned clinical trials and identifies barriers to compliance
Plans, proposes and evaluates means to overcome identified barriers to protocol compliance;
Interact with physicians, physical therapists, and occupational therapists treating ALS patients.
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
Participates in the integration of ALS multidisciplinary care with ALS clinical research.
The Nurse Practitioner will have a significant role in the administration of ALS clinical trials.
Anticipates research requirements for designated patient populations
Collaborates in development & writing of protocols and consent forms, as appropriate
Participates in preparing 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.
Recruitment & Enrollment:
Ensures initial & ongoing eligibility of all subjects for assigned research studies: Same as Level I.
Collaborates in the development and activation of recruitment strategies to ensure patient accrual within protocol timeframes.
Develops, submits to IRB and disseminates IRB-approved advertising to enhance protocol recruitment, including to print, broadcast and online media as appropriate
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, revisions and renewals 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.
Assists with electronic data entry as needed
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)
Coordinates and participates in sponsor/internal audits/monitoring
Communicates monitoring results to study team and develops strategies for addressing issues as appropriate
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
Collaborates in development of and presents information about ongoing/upcoming clinical trials for local, regional and national patient support group meetings as appropriate
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
Takes advantage of opportunities to make presentations in local community regarding research projects, areas of expertise, etc.
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)
Prepares IRB submissions for assigned protocols
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 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 and contract has been completed by all parties 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 and coordinates plans to address issues with PI.
Requires completion of a Nurse Practitioner program, and must be licensed in the State of Maryland by the Maryland Board of Nurses. 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 and BMC credentialing process is required.
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.
Additional Knowledge, Skills, and Abilities:
Demonstrated knowledge of computer applications and databases and of personal computer systems is highly desirable.
Ability to demonstrate knowledge and skills necessary to provide care appropriate to the age of the patients served. The individual must demonstrate knowledge of the principles of growth and development over the lifespan and possess the ability to assess data reflective of the patient's requirements relative to his or her age-specific needs, and to provide the care needed as described in the unit/area/department policies and procedures.
Knowledge of investigational therapies which require special expertise and clinical care management.
Highly effective verbal and written communication skills are required
Sitting, standing and walking for extended period. Reaching by extending hand(s) or arm(s) in any direction. Finger dexterity required to manipulate objects with fingers rather than with whole hand(s) or arm(s). Ability to move standard equipment through a hospital or clinical environment.
Classified Title: Nurse Practitioner Working Title: Nurse Practitioner Role/Level/Range: ACRP/04/MG Starting Salary Range: Competitive; Commensurate with experience Employee group: Full Time Schedule: M-F 8:30 am - 5:00 pm Exempt Status: Exempt Location: 04-MD:School of Medicine Campus Department name: 10003524-SOM Neuro Neuromuscular 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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