Nurse Practitioner

The Department of Neurology, Neuromuscular Division is currently searching for a full timeNurse Practitionerto 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:

Clinical Practice

Oversight:

• The Nurse Practitioner will participate in growing the ALS multidisciplinary clinic.

Planning:

• 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

Implementation:

• Collaborates with health care team to coordinate and facilitate protocol requirements for assigned clinical trials.

Evaluation:

• 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;

Consultation:

• 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

Clinical Research

Oversight:

• 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.

Pre-Study:

• 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

Quality Assurance:

• 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.

Patient/Family Education:

• 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

Staff Education:

• 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.

Community:

• 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.

Pre-initiation:

• 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.

Minimum Qualifications:

Requires completion of a Nurse Practitioner program, and must be licensedin 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.