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 study.
• Responsible for ensuring that performance of clinical trial complies with approved IRB protocol, GCP, and regulatory requirements of from FDA / Investigational Device Exemptions or related regulatory guidance documents.
• 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 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 Partners/MGH IRB. The majority of this research occurs in the participants’ place of residence; participants are severely disabled from 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 required from the Research Nurse in order to inspect the pedestal site (looking for signs of infection) and performing a limited neurological examination. All visits are reported on Case Report Forms. In support of this project, the Research Nurse will:
o After training by the PI, perform weekly/monthly in-home visits.
o Coordinate study-related inpatient and outpatient testing and care.
o 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.
o A series of patients have emailed and requested to be contacted if studies in their area open up. A database of “interested” patients, already started, will be updated and maintained.
• The Research Nurse will support the administrative structure of neurotechnology research, including 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.
• Coordinate patient care charges in hospital system for research activities
1. 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:
o Fielding emails / phone calls / inquiries regarding potentially eligible patients
o Ensuring that approved publicity posters remain in floor/unit locations
o Speaking with patients and, when appropriate, their family, about study enrollment
o Organizing and participating in consent meetings.
2. 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:
o Maintenance of a HIPAA/FDA/IRB-compliant log of all potential participants.
o Collection of patient-specific data (from medical records, etc.)
o 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
3. 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.
1. Team Management
• The Research Nurse will help the PI and other study investigators, in addition to the Clinical Oversight Committee, in preparing for regular team meetings (data reviews, conference calls, etc.), will develop an agenda for each meeting, and will create and distribute meeting minutes.
• New team members (students, residents, therapists) will join the BrainGate team occasionally. Responsible for providing training on clinical aspects of the study to new team members.
2. Clinical Site Monitoring
• Provide comprehensive regulatory oversight to multiple clinical trial sites
• Work collaboratively with internal (MGH) and external project team members.
• Maintain communication with clinical trial sites and in-house study staff.
• Act on behalf of Sponsor to resolve site related 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 site IRB submission
3. Data Safety and Monitoring Board Management
• Assist in transitioning from Clinical Oversight Committee to Data Safety Monitoring Board
• Work collaboratively with internal (MGH) team members to interact with new DSMB.
4. 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.
5. Supports growing 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 Stroke Motor Neurorehabilitation 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
6. Other duties as assigned
• Graduate of accredited school of nursing
• Active MA License as a Registered Nurse or Nurse Practitioner
• Minimum 5 years experience in inpatient and/or outpatient nursing required.
• Prior clinical trial experience required. At least 2 years of independent clinical monitoring 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
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.
None currently but anticipate supervisory responsibility in the future, as program grows.
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.
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-175 Cambridge – MGH
Work Locations: 175 Cambridge – MGH 175 Cambridge Street Boston 02114
Job: Registered Nurse
Organization: Massachusetts General Hospital(MGH)
Standard Hours: 40
Shift: Day Job
Employee Status: Regular
Recruiting Department: MGH Neurology Research
Job Posting: Feb 15, 2019
To apply, go to https://www.massgeneral.org/careers/jobsearch.aspx and search for job code 3085933