Jakaria Mostafa, Phd Email & Phone Number

Cincinnati, OH, US

• Provided day-to-day trial management support to maintain timeline in 8+ studies through start-up, maintenance, and close-out o Global Phase II-III gene therapy studies: AMD, Retinitis Pigmentosa, Leber Congenital.
• Provided input to study documents (e.g., protocol, statistical plan, data analysis plan, edit check specification) and reviewed and provided input to documents prior to regulatory submission (e.g., informed consent form)
• Developed study plans (monitoring and protocol deviation plan, risk management plan, recruitment plan etc.)
• Assisted Medical Affairs team to develop patient outreach materials, as per regulatory requirement
• Tracked study status including patient status, Case Report Form status, safety issues, timelines, etc.
• Point of contact to primary investigators, along with Medical Monitor, to address trial related scientific and safety queries

Cincinnati, OH, US

• Provided trial management support to the Clinical Trial Manager in 8+ studies through start-up, maintenance, and close-out phase; worked in a capacity as a Support Clinical Trial Manager.
• Led feasibility assessment and PI interaction, in collaboration with Clinical Trial Manager and Medical Monitor, to select new sites.
• Created study timeline, maintained Trial Master File (TMF), created and distributed study and site materials.

Houston, Texas, US

• Proposed, designed and executed multiple clinical experiments to investigate vision abnormalities in patients with brain injury which resulted in 6 peer reviewed scientific works.
• Led project involving 12+ ophthalmology devices and clinical techniques (ocular imaging OCT, AO, electrophysiology ERG, mfERG, VEP, mfVEP, visual field, pupil testing, melanopsin, contrast sensitivity, color vision.
• Maintained compliance with clinical research policies while developing 2 extensive clinical project related IRB approval and regulatory documents (i.e. Protocol, Informed Consent, HIPAA)
• Cultivated an extensive collaborative team with MDs, ODs, PhDs, engineers and other leaders of the field to manage and complete 6 cross-functional collaborative projects on time.
• Proved ability to think critically and propose ideas, evidenced by 5 winning grants (total of >30,000$).
• Developed 3 new clinical parameters and protocols while writing MATLAB algorithm to analyze patient data.

Houston, Texas, US

• Proved team management skills as Head TA while leading a group (received the best TA Award).
• Spearheaded development of a novel performance rubric to monitor student progress during lab activity.

• Provided expert opinion to the neuro-ophthalmologist to select a customized visual electrophysiology protocol for each patient which significantly improved patient care in more than 20 patients.
• Integrated, synthesized and interpreted raw clinical data and assisted to identify the best treatment strategy.
• Prepared 10+ patient reports ensuring appropriate interpretation of scientific data in clinical documents.

Dhaka, BD

• Led a team to roll-out sites in a new region, which increased network coverage by 25%
• Monitored and documented site operation. Performed routine site visits and managed vendors
• Communicated plan and timeline to senior management through regular preparation of study reports

Doctor Of Philosophy - Phd, Vision Science/Physiological Optics

Bachelor Of Science - Bs, Electrical And Electronic Engineering