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Family Practice
- Length of assignment :
-6 months+
-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 Calendly, 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
Possible 10% travel to see patients in person
******** 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.
- Primarily focused on the DEEs we may require him/her to support other studies within the Epilepsy portfolio
(DEE refers to a group of severe epilepsies that are characterized both by seizures, which are often drug resistant, as well as encephalopathy, which is a term used to describe significant developmental delay or even loss of developmental skills)
- This is for our Pediatric Trial so we are looking someone who has some neurology experience BUT more importantly can handle routine comfort and CARE
- They will be tasked with:
• Determining subject eligibility
• 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
-ACTIVE GCP certification (Good Clinical Practice)
******We require the physician to have the following state licenses for sure, ideally we are looking for a multi-state licensed physician, these states are a must, but we are looking for more:
-Florida, NY, Michigan, Illinois, Nevada, PA, CA, VA, South Dakota, and Oklahoma.
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