We are seeking a CO Research Assistant (RA) who will be directly involved in clinical research in the neurological critical care unit (NCCU), both at JHH and Bayview Med Center, under supervision by Dr. Susanne Muehlschlegel (Director of Clinical Research in NCCU and PI) and Dr. Vishank A. Shah (PI). The purpose is to actively screen, recruit, and retain research participants in clinical research studies in the NCCU, maintain regulatory documents, including IRB protocols, regulatory binders, and communicate with PI’s and IRB. Appropriate training will be provided, together with guidance by senior research staff in the Department of Anesthesiology & Critical Care Medicine.

At the beginning the primary focus will be on enrollment, data extraction and follow-up for the below listed prospective study:

• Individualization of Arterial Blood Pressure Targets in Aneurysmal Subarachnoid Hemorrhage Using Non-Invasive Multimodal Neuromonitoring (internal ACCM funding)

In addition, the RA will support other research assistant in screening and enrollment in three studies listed below:

• Pilot Trial of a Web-Based Decision and Communication Tool for Goals of Care Decisions by Surrogate Decision-Makers of Critically Ill Patients with Severe Acute Brain Injury (severe strokes and traumatic brain injury) (NIH and internal ACCM funding)
• Clinician-Family Meeting Recording Study to Study Prognostication and Communication in Critically Ill Neurologic Patients – a Mixed Methods study (internal neurology funding)
• TBI Biomarker Validation Study (NIH funded)

Enrollment, data extraction, follow-up calls in these studies will be the main focus, but enrollment will ebb and flow, and with more experience and expected efficiency, the RA may become involved additionally in other clinical studies in the NCCU (for example clinical trials), which are either currently ongoing or will start in the future.

Some of these trials have a narrow enrollment time window and therefore may require being “on call” from home, with the rare requirement to travel to the hospital for timely enrollment into the trial. If the RA comes to the hospital during off hours, RA will receive time off during regular duty hours to compensate for the time worked. The RA will be contacted by the PI or another screening doctor only if they believe the patient is highly likely to enroll.

RAs will receive appropriate education and training on how to approach families and clinicians for the listed studies, as well as required regulatory work in human subject's research, e.g., IRB, study binder maintenance, HIPPA security, data safety, etc., under the guidance of the PI (S. Muehlschlegel) and research nurses/supervising staff (for example within the ACCM Clinical Research Core). Empathetic communication and respect for all patients, families, and team members is a minimum requirement.

Specific Duties & Responsibilities 

Screening and Enrollment

• Log into EPIC daily first thing in the mornings to screen for patients; confirm eligibility with PI as necessary.
• Walk to ICU daily to meet with clinical ICU team (rounding fellows/residents/attending and nursing) to confirm eligibility and rule out reasons not to approach.
• Enrolling participants by connecting them to the non-invasive neuromonitoring devices, such as placing non-invasive sensor on forehead of the patient (training will be provided)
• Assessing neuromonitoring device twice a day to ensure that sensors are connected to patient and data is recording.

Data Extraction

• Screening the monitored data to erase artifacts (training will be provided)
• Extraction of hourly neuromonitoring data from the ICM+ software into Excel (training will be provided)
• Plotting autoregulation curves using Excel (training will be provided)
• Proficiency with using Microsoft Excel is required.

Completing Telephone Follow-Ups

• This will involve calling enrolled participants at 90 days, 180 days and 1 year after enrollment in the study to obtain outcome assessments via telephone including survival data, modified Rankin Scale and cognitive function scale (training will be provided)

Other responsibilities for above study and other studies listed will include and not limited to

• Work with nursing staff, social worker, or other support staff to approach family member for consent. This may be in person, or sometimes over the phone or video conference. Depending on the study and IRB approval this may be written consent or verbal consent. Training together with a consent script will be provided.
• Complete fidelity to research and IRB protocol; use of checklists is encouraged; excellent planning and executive function skills are expected.
• Knowledge and fidelity to HIPPA and human subjects' data protection rules.
• Maintenance of screening and consent log, including reasons for ineligibility or decline of consent.
• Knowledge of web-based DA tool (training to be provided)
• Establish and maintain good working relationship with web-tool/app programming team at Worcester Polytechnic Institute (WPI) or other outside collaborators (e.g., biomarker validation study team in UMass Amherst)
• Proactively analyzing and addressing the reasons for low consent rates in collaboration with the PI
• For audio-recording study: audio record clinician-family meetings using a portable audio-recording device and follow-up with clinician and family members afterwards (max within 24h) to have them complete post-meeting questionnaires.
• Data collection and data entry using RedCAP secure data portal.
• For biomarker study: communicate with bedside ICU nurse about timing of blood draw, ideally from arterial or central line, hand blood tubes to nurse, receive back, spin sample, and either store in freezer for batch shipping, or send off in special whole blood packages provided by sponsor.
• Organize and maintain all other research and lab data on password protected SAFE cloud drive.
• Batch transfer MP3 recordings to IRB approved external HIPPA safe transcription service.
• Organization of weekly lab meeting (email invites, agenda, topics)
• Attend all team meetings to learn and offer input to optimize recruitment, retention, and fidelity into study.
• Attend and prepare nursing education and provider education sessions and materials (e.g., PPT) about research studies.

• Bachelor's Degree in related discipline.
• Additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.

Classified Title: Research Assistant 
Job Posting Title (Working Title): CO Research Assistant   
Role/Level/Range: ACRO40/E/03/CD  
Starting Salary Range: $17.20 - $30.30 HRLY ($20.43/hour targeted; Commensurate with experience) 
Employee group: Full Time 
Schedule: Mon-Fri 
Exempt Status: Non-Exempt 
Location: School of Medicine Campus 
Department name: ​​​​​​​SOM Ane Research  
Personnel area: School of Medicine