Neurotechnology Research Nurse

Boston, MA       ·       Part time

Job Description

General Summary/ Overview Statement:

• Responsible for executing clinical activities of the BrainGate research, as well as additional clinical research-related endeavors in neurology and neurotechnology, including the SMaHRT studies.
• Responsible for ensuring that performance of clinical trials complies with approved IRB protocols and GCP.
• Provide first-line interaction between study staff and potential clinical research participants inquiring about research and clinical activities in neurotechnology
• Perform clinical research data collection with research participants in a variety of clinical settings (inpatient, outpatient, participant home, remote) and ensure that research data is accurate and complete.

Principal Duties And Responsibilities:

Feasibility of the BrainGate Neural Interface System

• The “BrainGate” study is an ongoing, multi-site pilot Investigational Device Exemption trial, performed under the oversight of the MGB IRB. Much of this research occurs in the participants’ place of residence; participants have cervical spinal cord injury, brainstem stroke, muscular dystrophy, or ALS. In support of this project, weekly (for 6 weeks) and then monthly (for a year or more) home visits are performed by the Research Nurse (sometimes together with the site-responsible Investigator) to inspect the pedestal site (looking for signs of infection) and to perform a limited neurological examination. All visits are reported on Case Report Forms. In support of this project, the Research Nurse will:
  • After training by the PI, perform weekly/monthly in-home visits.
  • Coordinate study-related inpatient and outpatient testing and care.
  • Help the PI in replying to email and telephone inquiries from potential study participants and their families. Responses are drafted based on pre-existing templates.
  • Maintain a database of “interested” patients, and help in trial recruitment.

• The Research Nurse will support the Center for Neurotechnology and Neurorecovery (CNTR) administrative, including assisting the Regulatory Manager in preparation of research-related documents for FDA and other institutions.
• Prepare and maintain study documents including informed consent forms, protocol, Case Report Forms, training manuals and logs, regulatory binders, recruitment advertisements and other materials.
• Review and coordinate patient care charges in Epic for research activities

Patient Recruitment

• Adequate recruitment of study participants is a critical link in any successful clinical research endeavor. Recruitment is particularly challenging for trials with strict and numerous inclusion criteria. For the BrainGate study, patient recruitment will require regular interaction, via email and telephone, with the teams (nurses and physicians) whose patients may be appropriate for study recruitment. Related activities include:
  • Fielding emails / phone calls / inquiries regarding potentially eligible patients
  • Ensuring that approved publicity posters or information remain in floor/unit locations or other electronic media
  • Speaking with patients and, when appropriate, their family, about study enrollment
  • Organizing and participating in consent meetings.

Data Gathering and Data Sharing

• The BrainGate study has three types of “data”: Data about the participants (e.g., age, disease/injury, medications, physical examination, MMSE results; “clinical data”), the actual waveforms and performance metrics collected by the system (“neural data”), and video recordings of the clinical trial sessions (“video data”). Collection, maintenance, and reporting of the Clinical Data is a primary objective of the Research Study Nurse. Successful data analysis will be dependent upon exquisite record keeping (both paper and computer database). Thus, this role will involve:

Maintenance of a HIPAA/FDA/IRB-compliant log of all potential participants.

• • Collection of patient-specific data (from medical records, etc.)
  • Adverse event reporting (completion of Case Report Forms and IRB AE forms as needed)
• May train other team members involved in the clinical aspects of the BrainGate study

Investigation and Management of Adverse Events

• Participants in the BrainGate trial are inherently at risk for adverse events. The clinical study team, represented first by the Research Nurse, will need the ability to respond, sometimes in person, quickly, to any possibly trial-related adverse event. In addition, caregivers may call with questions regarding the management of a non-trial-related illness. While we do not direct non-study-related medical care for trial participants, it is important to coordinate with the participant’s PCP or specialists to ensure that care is safe and appropriate in the context of the clinical trial, and/or that trial procedures are modified in response to the participant’s health condition.

The Research Nurse role for this project will also:

• Be responsible for identifying areas for streamlining and process improvement in the data collection process.
• Demonstrate appropriate utilization of resources necessary to obtain valid, reliable data for entry into the research database.

Team Management

• The Research Nurse will help the PI and other study investigators, in addition to the Data Safety and Monitoring Committee, in preparing for regular team meetings (data reviews, conference calls, etc.), will develop an agenda for each Clinical Oversight Committee meeting, and will assist in creating and distribute meeting minutes, particularly with respect to clinical discussions.
• New team members (students, residents, therapists) will join the BrainGate team occasionally. The Research Nurse will be responsible for providing training on clinical aspects of the study to new team members.

Clinical Site Monitoring

• Work collaboratively with internal (MGH) and external project team members.
• Maintain communication with clinical trial sites and in-house study staff.
• Review Case Report Forms submitted by all sites, requesting clarification when needed, and ensuring Sponsor-Investigator review and adjudication.
• Act on behalf of Sponsor-Investigator to resolve site related clinical research issues.
• Provide centralized site support, communication and coordination.
• Develop and revise the monitoring plan for assigned studies.
• Independently monitor clinical sites including: initiation, interim and closeout visits.
• Provide investigator and study staff training as needed.
• Develop informed consent templates and review site Informed Consent Forms prior to sIRB submission

Data Safety and Monitoring Board Management

• Work collaboratively with internal (MGH) team members to interact with the DSMB.

Works Effectively with Patients, Families, and Staff

• Has strong interpersonal skills with ability to communicate verbally and in writing to establish effective working relationships with members of the Hospital community, especially staff in the Neurology, Neurosurgery, Nursing, Occupational/Physical/Speech & Language Therapy, Pulmonary, and Surgery services whose support is necessary for the research to be successful.
• Work independently and coordinate activities closely with PI and other investigators via email and telephone, as well as via regular in-person meetings.

SMAhRT Study

• Assists in the recruitment of inpatients with stroke
• Assists and/or independently collects (after training) the collection of rehabilitation robotics, transcranial magnetic stimulation, EEG, and upper extremity function scores with inpatients and outpatients.
• Assists in scheduling outpatient study participants for study follow-up.

Supports the Center for Neurotechnology and Neurorecovery (CNTR)

• Maintains current knowledge of appropriate related research and identifies clinical issues appropriate for study.
• Supports other CNTR research studies and clinical care in TBI, Stroke, Epilepsy, and Spinal Cord Injury, including inpatient clinical research studies in the Neurosciences Intensive Care Unit (Lunder 6) and the Neurology floors (Lunder 7 and 8)
• Coordinates clinical-research interactions with outpatients being followed in the MGH NeuroRecovery Clinic
• Responsible for the preparation and presentation of clear, precise and clinically accurate summaries of review findings including their significance and implications to various audiences.
• Supports and helps to manage other Epilepsy, TBI, Stroke, and related research studies
• Assists in interaction with industry partners, including preparation of clinical trial budgets

Other duties as assigned

Qualifications:

• Bachelor’s degree in nursing required. Graduate of accredited school of nursing may be accepted with additional commensurate and direct nursing experience.
• Active MA License as a Registered Nurse
• Minimum 3 years experience in inpatient and/or outpatient nursing required.
• Prior experience in neurologic/neurosurgical care and research/clinical trials preferred.
• Willingness to obtain licensure in another state if required for clinical research activities.
• Preferred: Certified Clinical Research Associate by the Association of Clinical Research Professionals (ACRP) or equivalent.

Skills/ Abilities/ Competencies Required:

• Ability to establish effective working relationships with all members of the Hospital community
• Able to work independently and in teams
• Demonstrates excellent organizational skills
• Demonstrates excellent and effective writing and communication skills
• Comfortable working with computers, including custom software
• Computer and Internet skills and experience required – familiarity and comfort with MS Office products is essential for success in this position (Word, Excel, PowerPoint, Outlook, Adobe Acrobat Pro).
• Comfort working in MacOS environment required.
• Is knowledgeable and compliant in all hospital, State and Federal regulatory requirements, including hospital policy and procedures (where applicable to the performance of the job), Joint Commission on Accreditation of Healthcare Organizations (JCAHO), and Health Insurance Portability and Accountability Act of 1996 (HIPAA).
• Completed hospital-based certifications for education in human subjects research protections (e.g., CITI web-based course or equivalent).
• Ability to travel to multiple locations/sites

Working Conditions: Multiple locations including normal office conditions, inpatient clinical environments (including ward and intensive care unit), outpatient clinics, “house calls” (patient or research participant home). Travel to other clinical sites may require occasional air travel and overnight stay. Part of a team of physicians and nurses that provide 24/7 research pager coverage.

Superior Responsibility: None currently but anticipate supervisory responsibility in the future, as program grows.

Fiscal Responsibility: No direct fiscal responsibilities; however, is responsible for prudent fiscal management of program resources (e.g. supplies, etc.). Assist in the purchasing of clinical research supplies. Careful assessment and engagement in reporting patient care charges for inpatient activities related to research studies.

EEO Statement

Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. Applications from protected veterans and individuals with disabilities are strongly encouraged.

Primary Location: MA-Boston-MGH Main Campus
Work Locations: MGH Main Campus, 55 Fruit Street, Boston 02114
Job: Registered Nurse
Organization: Massachusetts General Hospital(MGH)
Schedule: Part-time, Standard Hours: 15
Shift: Day Job
Employee Status: Regular
Recruiting Department: MGH Neurology Research
Job Posting: Apr 12, 2022

Please click here to apply.