NADEEM M AKHTAR
Mississauga,ON
Summary
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 Rezdiffra for fatty liver and MASH , The team has actively screened and enrolled subjects for the study.
Overview
19
19
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator III in Multi-Clinical Trials (NASH) and Cirrhosis [phase 2 and 3 ]
Fresno Clinical Research Center
08.2020 - Current
- 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( Rezdiffra) 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.
05.2014 - 05.2019
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 COVs 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
06.2006 - 08.2014
- 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
Education
M.D Summa Cum Laude - general medicine
UMF Carol Davila
Romania09.1989
Skills
- Good clinical practices
- Electronic data capture
- Informed consent process
- Patient recruitment
- Site management
- Medication dispensing
- Records maintenance
- Clinical trial management
- Documentation requirement
- Adverse event reporting
- Data collection techniques
- Research sops understanding
Accomplishments
- Achieved goals by completing routine patient follow up visits with accuracy and efficiency.
- Collaborated with team of 100 in the development of Rezdiffra.
- Supervised team of 10 staff members.
- Used Microsoft Excel to develop inventory tracking spreadsheets.
- Documented and resolved AE and SAE which led to better outcome for clinical subjects and for study as well
Computer Skills
- MS word, Excel and Power point
Certification
- Sept 2004 MCCEE, Medical Council of Canada
- July 2012 USMLE Step 1, ECFMG
- Dec 2015 USMLE Step 2 CK, ECFMG
- June 2020 COVID-19 Contact Tracing as Public Health Tool Certification John Hopkins Bloomberg School of Public Health
- Oct 2022 CITI ICH GCP Certification, CCRPS Advanced Clinical Research Coordinator Certification , Fibroscan Certification, Valacur-1 Ultaosund Certification, Oncoustics Ulrtsound Certification
LANGUAGES
Fluent In English, Arabic, Urdu, Hindi, Romanian and Hungarian
Personal Information
Awards
Sept 1989 M.D Thesis “The Efficiency of the Laboratory Methods in Diagnosing Bacterial Meningitis”. Successfully defended the Thesis with 10/10, Passed Romanian Board exam with 9.2 out of 10 GPA
Publications
- Nadeem Masood Akhtar, M.D (2007, Oct). Atomoxetine (ATX) potent and selective presynaptic transporter reuptake inhibitor, first non-stimulant widely used in the treatment of ADHD in children, adolescents and adults. Child and Adolescent Psychopharmacology News. Vol 12, Iss. 5, pp. 4-7.
- Nadeem Masood Akhtar, M.D(2007, Dec). Guanfacine ( Intuniv): a non-stimulant selective alpha-2A receptor agonist has been studied in children and adolescent with ADHD. Child and Adolescent Psychopharmacology News. Vol 12, Iss. 6, pp. 8-10.
- Nadeem Masood Akhtar, M.D and Afreen Bano Khan, M.D (2008 June) Olanzapine(Zyprexa) : A Novel atypical antipsychotic and the therapeutic advantage attributed to the alpha- 2 adrenergic antagonist effects. Child and Adolescent Psychopharmacology News. Vol. 13, No 3: pp.7-9.
- Nadeem Masood Akhtar, M.D and Afreen Bano Khan, M.D (2008 Oct) Bupropion (Wellbutrin, Zyban): a unicyclic antidepressant acts as a norepinephrine and dopamine reuptake inhibitor and nicotinic antagonist. Child and Adolescent Psychopharmacology News. Vol.13, No.5: pp 6-9.
- Nadeem Masood Akhtar, M.D and Afreen Bano Khan, M.D ( 2008 Dec) Aripiprazole (Abilify): A Novel Atypical Antipsychotic with somewhat unique pharmacological profile, partial agonist at D2 and 5-HT1 A receptors. Child and Adolescent Psychopharmacology News Vol 13, No 6: pp 1-4
- The Performance of Velacur Against Liver Biopsy for Assessing Fibrosis and Steatosis: Muhammad Y. Sheikh¹, Nadeem M Akhtar¹, Marwan Almozaughi¹, Caitlin Schneider² ¹Fresno Clinical Research Center, California, ²Sonic Incytes Medical Corp, British Columbia.
Timeline
Clinical Research Coordinator III in Multi-Clinical Trials (NASH) and Cirrhosis [phase 2 and 3 ]
Fresno Clinical Research Center
08.2020 - Current
Clinical Research Coordinator II
North American Research Institute Inc.
05.2014 - 05.2019
Teaching Assistant
College of Pharmacy, Dalhousie University
06.2006 - 08.2014
M.D Summa Cum Laude - general medicine
UMF Carol Davila
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