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 Amaurosiso USA-based Phase I studies: COVID-19, Advanced Solid Tumor (Oncology), Renal Device • 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 • Created, reviewed, and approved site monitoring tools and site visit reports. Maintained CRA oversight.

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, vision charts, visual questionnaires, neuro-psychological testing etc.) • 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.• Effectively communicated scientific/clinical findings in 15+ meetings, resulted in 3 best presenter awards.

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