Work location details: Fully remote

Specialty needed: Physician Clinical Trial Sub-Investigator (also called Sub-I’s)

- All Physician specialties eligible, pediatric neurology preferred

Number of providers needed: 1-2, possibly more

- Length of assignment :

**Study is set to begin in the first quarter of 2025

-6 months+ for initial efficacy trail with the option to extend into the Long-Term Safety Study (LTSS)

-This trial will go on for another 18+ months, with the opportunity to work on additional trials in the future

Schedule:

• Provider should be able to offer a minimum of 20+ hours per week, in 3+hr blocks, consistently.
• They will be asked to provide their specific availability through Outlook, and this will be used as the main scheduling tool for the patients to meet with the physician.
• M-F between the hours of 8am – 6pm
• Evening and weekend blocks accepted on a case per case basis

• Work Details:

** Providers (also called “Sub’I’s) will be aligned with a patient and will follow the visit schedule for the trial and throughout the patient's journey as part of the study.

**They will be tasked with providing virtual consultation and oversight during study visits with participants

• Determining subject eligibility
• Document visit findings and relay to the PI in accordance with agreed procedures.
• Reviewing Columbia Suicide Severity Rating Scale (C-SSRS) assessments
• Overseeing of Adverse Event (AE) Relatedness / Severity Assessments
• Deciding on the Discontinuation of Trial Treatment/Emergency unblinding treatment.
• Overseeing Clinical Reports (ECG, Central Lab Testing)

o Conducting and recording Video Neurological Examination assessment for Eligibility Review Committee submission.

o Performing protocol eCOA efficacy and safety assessments (TETRA S-ADL, CGI-S, C-SSRS, oversee participant PGI-S, PGI-C)

o Assessing Physical Exam results

o Reviewing Lab Results for Clinical Significance

o Interpretating above reports and reporting their findings

• Signing Case Report Forms

• Requirements :

-Board Certification within the Physician Scope of Practice

-Clinical trial experience as a Sub-Investigator

(Please state in submission how many years of experience as a Sub-I)

-ACTIVE GCP certification (Good Clinical Practice)

-The Good Clinical Practice Certification is designed to give the researcher a basic understanding of the regulations and requirements for research using investigational (not approved by FDA) drugs or devices.

-20+ ACTIVE state licenses - no exceptions

-Priority is for the states of Massachusetts and Virginia

-Please outline all active licenses, as well as their expiration dates (provider is responsible for the renewal and upkeep of licensure)

-If IMLC, please provide LOQ (Location of Qualification)

- Submissions should please include:

- NPI, DOB, and a summary of qualifications listed above

- Bill/Pay is open within these parameters and are specialty-based (neuro highest billed):

- Onboarding (aka credentialing/training) is paid hourly and is self-guided

- Expectation is that onboarding should take approx. 20hrs and should take no longer than 2-3 weeks

• 20hr/week GUARANTEE after onboarding is complete