Working in the Center for Neurotechnology and Neurorecovery

We are always looking for excellent candidates who hope to build a career centered around the development and understanding of novel neurotechnologies aimed at improving clinical care for individuals suffering from disease and injury of the nervous system.  If you are interested in joining our team of dedicated clinicians, scientists, engineers, and researchers, please check out the open positions listed below.

Neurotechnology Research Nurse  (job code 3085933)

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 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

Qualifications

 QUALIFICATIONS: 

• 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

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.

SUPERVISORY 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-175 Cambridge – MGH
Work Locations: 175 Cambridge – MGH 175 Cambridge Street Boston 02114
Job: Registered Nurse
Organization: Massachusetts General Hospital(MGH)
Schedule: Full-time
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

Clinical Research Coordinator  (job code 3086661)

Description

GENERAL SUMMARY/ OVERVIEW STATEMENT:

The Clinical Research Coordinator for Neurotechnology and Neurorecovery is primarily responsible for the performance of clinical research on the MGH inpatient neurology services and during outpatient neurology clinic visits. These responsibilities include the careful execution and documentation of research evaluating recovery for people with stroke and other forms of neurologic injury.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

  • Recruit participants into recovery- and neurotechnology- focused research studies.
  • Obtain informed consent forms from research participants.
  • Assist in quality improvement initiatives related to stroke recovery and technology.
  • Learn, perform, and carefully document standardized clinical assessments of motor recovery.
  • Arrange, schedule, and perform daily research sessions, requiring careful coordination and regular interaction with persons with stroke, care teams, and families/caregivers. These research sessions occur at MGH in both inpatient and outpatient settings.
  • Learn and perform kinematic assessments of motor recovery using inertial sensors and robotics.
  • Learn and perform basic neuroimaging (structural MRI) analyses.
  • Learn and help with recording electroencephalography (EEG) using custom technology and software for assessment of motor recovery.
  • Learn and help with the performance of non-invasive neurostimulation (i.e. transcranial magnetic stimulation) for analysis of motor recovery.
  • Act as a study resource for patients and families.
  • Contribute to research protocol recommendations.
  • Call participants in-between research sessions to check-in with ongoing research participation.
  • Monitor and maintain research data, patient files, regulatory binders and study databases.
  • Work closely with mentors in the MGH Center for Neurotechnology and Neurorecovery (CNTR).
  • Work closely with other research coordinators in the MGH CNTR.
  • Assist with other neurotechnology and neurorecovery research projects, as assigned by mentors.
  • Attend regular lab meetings (in person or by videoconference).
  • Enhance web presence for research and for the MGH CNTR.

SKILLS/ABILITIES/COMPETENCIES REQUIRED:

  • Excellent interpersonal skills and ability to work as part of highly multidisciplinary teams.
  • Ability to comfortably and sensitively interact with study participants, including patients with acute neurologic illness and their families.
  • Ability to take initiative and prioritize tasks.
  • Ability to coordinate research activities with all members of inpatient clinical care teams.
  • Excellent organizational skills and ability to multi-task.
  • Excellent attention to detail and ability to document research activities.
  • Excellent writing and communication skills in the English language.
  • Excellent problem-solving skills.
  • Safeguards the privacy of information and keeps appropriate information confidential.
  • Ease interacting with and taking direction from multiple levels including senior research coordinators, physicians, scientists, and engineers.
  • Total comfort in Microsoft Windows environments, including ability to troubleshoot simple computer problems independently. Comfort working with Apple OS and in MATLAB environments is advantageous.

Qualifications

EDUCATION:

Bachelor’s degree required.

EXPERIENCE:

Preferred: 1-2 years work related experience. Applicants with at least one full year of research laboratory or clinical environment work experience during their undergraduate studies will be considered.

WORKING CONDITIONS:

The successful candidate will perform his/her primary duties in the office environment as well as at related laboratory space on the MGH campus, the inpatient ward, and outpatient clinics of the Department of Neurology at MGH. When necessary, s/he may be asked to transfer of research equipment, some of it heavy but on wheels, between different parts of the hospital. There is no projected work outdoors. There is no projected work involving hazardous materials.

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-175 Cambridge – MGH
Work Locations: 175 Cambridge – MGH 175 Cambridge Street Boston 02114
Job: Clinical
Organization: Massachusetts General Hospital(MGH)
Schedule: Full-time
Standard Hours: 40
Shift: Day Job
Employee Status: Regular
Recruiting Department: MGH Neurology Research
Job Posting: Feb 26, 2019

To apply, go to https://www.massgeneral.org/careers/jobsearch.aspx and search for job code 3086661

IRB Coordinator  (job code 3090779)

Description

GENERAL SUMMARY/ OVERVIEW STATEMENT:

The Center for Neurotechnology and Neurorecovery (CNTR) at Massachusetts General Hospital is seeking IRB Coordinator to engage in cutting-edge neurotechnology and neurorecovery research including brain-computer interfaces (BCI), epilepsy, high-resolution neurophysiology, traumatic brain injuries (TBI), and stroke recovery clinical trials.

Primary responsibilities:

  • Serves as lead person responsible for managing interactions with Partners IRB for all CNTR protocols
  • Responsible for tracking, filing, executing and monitoring IRB activities of the CNTR clinical trials
  • Perform administrative duties as assigned

The successful candidate will be directly mentored by the Principal Investigators in the MGH CNTR and will become part of a highly active and productive community of researchers, neurologists, computational neuroscientists, and neuroengineers. For more information about the MGH CNTR, please visit http://cntr.mgh.harvard.edu

PRINCIPAL DUTIES AND RESPONSIBILITIES:

  • Collaborates with PIs to prepare IRB and any other regulatory submission documents as required by the protocol.
  • Responsible for preparation and submission of IRB amendments, Continuing Reviews and other required forms in Insight.
  • Coordinates with Principal Investigators (PIs) to help ensure that clinical research and related activities are performed in accordance with federal regulations and Partners IRB policies and procedures./li>
  • Assures that all key personnel or persons ‘engaged’ in the research project have met training requirements in accordance with federal regulations and Partners policies and procedures.
  • Reviews and comprehends all CNTR protocols.
  • Prepares/ updates other study materials including, but not limited to, the informed consent document, case report forms (CRFs), recruitment flyers, enrollment logs, and drug/device accountability logs, AE/SAE logs.
  • Assists Research Nurse with maintaining study files, including but not limited to, regulatory binders, study specific source documentation and other materials.
  • Assists Research Nurse with administrative structure of neurotechnology research, including preparation of research-related documents for FDA and other institutions
  • Responsible for preparation and submission of IRB amendments, Continuing Reviews and other required forms in Insight.
  • Acts as a key liaison and serves as a primary contact for all IRB-related communications.
  • Act as resource for all study teams for IRB related submissions and document collection/review/approval
  • Coordinates all sIRB/SMART activities for CNTR, including close relationships with other (non-Partners) clinical sites.
  • Maintains records and databases
  • Assists with regulatory binders and QA/QC procedures related the CNTR studies
  • Performs administrative support duties as required
  • May assist with recruiting patients for recovery-focused clinical trials

SKILLS/ABILITIES/COMPETENCIES REQUIRED:

  • Familiarity with Partners IRB policies and procedures is advantageous
  • Working knowledge of clinical research protocols
  • Careful attention to details
  • Excellent organizational skills
  • Ability to follow directions
  • Good communication skills
  • Excellent interpersonal skills and ability to work as part of highly multidisciplinary teams.
  • Computer literacy; comfort working with Apple OS is advantageous.

Qualifications

EDUCATION:

Bachelor’s degree required.

EXPERIENCE:

A minimum of 2 years experience as IRB Coordinator, or experience working directly for the IRB

SUPERVISORY RESPONSIBILITY (if applicable):

No supervisory responsibilities

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-175 Cambridge – MGH
Work Locations: 175 Cambridge – MGH 175 Cambridge Street Boston 02114
Job: Clinical
Organization: Massachusetts General Hospital(MGH)
Schedule: Full-time
Standard Hours: 40
Shift: Day Job
Employee Status: Regular
Recruiting Department: MGH Neurology Research
Job Posting: Apr 8, 2019

To apply, go to https://www.massgeneral.org/careers/jobsearch.aspx and search for job code 3090779

Massachusetts General Hospital and Harvard Medical School