Nadeem Akhtar

I am M.D and have 10 years' experience in Clinical Research specially in Phase 2 and phase 3 of the Clinical trials. I have worked closely with P.I and Monitors to ensure that goals are achieved, and clinical subjects are healthy and safe. The team efforts got recognized when FDA has approved Redziffra for fatty liver and MASH, The team has actively screened and enrolled subjects for the study.

Clinical Research Coordinator III in Multi-Clinical Trials (NASH) and Cirrhosis [phase 2 and 3] - Fresno Clinical Research Center - Fresno, California

(2020-08)

• Scheduled subjects with routine visits and research procedures
• Oversaw and trained other CRC and research staff to ensure that Protocol requirements were followed
• Reviewed new study protocols for feasibility, and assisted with Regulatory submissions to the IRB and Sponsor/CRO
• Managed and organized regulatory documentation and Maintained the accuracy of data
• Collaborated with CRAs and auditors during all monitoring Visits and reviewed source documents case report forms prior To study monitoring visits and / or audits. Processed and Maintained Biopsy logs for research subjects
• Prescreened , screened subjects for Nash Studies, enrolled and Randomized in Phase 2 and Phase 3 clinical study, especially for a Clinical Study. the IP( Rezzdifffra) was approved by FDA in April 2024.
• Followed closely and vigilantly all the IP related AE''s and SAE's

Clinical Research Coordinator II - North American Research Institute Inc. - San Dimas, California

(2014-05 - 2019-05)

• Initiated and completed action items and queries. Performed And reviewed e-CRF, worked with CTMS, managed TMF work
• Collected documents remotely, performed PSV's, SIV's and COV's have monthly meetings with CRA on the field
• Monitored AE''s and SAE''s with medical monitor on regular basis

Teaching Assistant College of Pharmacy - Dalhousie University - Halifax, Canada

(2006-06 - 2014-08)

• In Problem-Based Learning, facilitated and supervised group discussions, assessed performances of 2nd, 3rd and 4th year undergraduate students created behavior-based learning environment, tutored pharmacokinetics, pharmacodynamics, adverse events and serious adverse events
• Participated in faculty meetings to set up clinical cases for PBL

Clinical Research Assistant, Project: Literature review and Compilation of psychotropic Medications in Child and Adolescent Psychiatry - Sun Life Financial Chair in Adolescent Mental Health and Director of World Health Organization/Pan American Health Organization Collaborating Center in Mental H

(2006-05 - 2008-12)

Prof. Dr Stanley Kutcher

M.D - Summa Cum Laude general medicine - UMF Carol Davila (1989-09)