MUHAMMAD SHAHAB KHURSHID

MDA Road St.# 2 New Shadab Colony Multan, Punjab Pakistan.

shahabwassi@gmail.com
0341-5540190
01-04-1994

NIH Certified Researcher

GCP Professional
GCP Professional having experience in Quality Assurance of Clinical trials.
Regulatory/Dossiers Submissions to DRAP and NBC for Clinical Trials Approvals
Communicating Professionaly and effectively with culturally diverse groups

Objective
Obtain position in Multinational Company in an environment where I will get a chance to utilize my knowledge and my experience. Assist in designing
clinical research projects and project plans.

Education
Baha-ud-din Zakriya university Multan. 2014-2019
Doctor of Pharmacy (PharmD)
66.17%
Board of Intermediate and Secondary Education Multan 2011-2013
Fsc-Pre Medical
86.16%
Govt. H/S shorkot District Jhang. 2010
Matriculation
78%

Experience

OrciTrials Pvt. Ltd. April 2022 - May 2021

Clinical Research Associate
1. Implementation of GCP guidelines
2. Site feasibility report preparation 
3. ISF management 
4. Coordination with regulatory authorities 
5. Training on GCP 

DRK pharma Solutions Pvt. Limited Jan 2021 - April 2021

CRA
Working as CRA in COVID-19 phase III CT 
Preparation of Site initiation Report
Site Selection Visit Reports
Monitoring Visit Reports
Source Data Verification (SDV)
Liaison between PI, Trial Staff and Sponsor
Training of Site staff
ICHGCP guidelines Implementation
Working as CRA COVID-19 phase III Vaccination Trial. Audited University of Health Sciences, Central Parks Teaching Hospital & National Hospital and Medical
Center Lahore, Pakistan.
Implementation of ICH-GCP guidelines.
Preparation, Revision and implementation of SOPs and Protocols implementation in CT.
EDC check e.g. SDV check through Viedoc, OpenClinca and Medidata etc.
Maintenance and handling of Trial Master File (TMF) & Investigational Site File (ISF) i.e. Proctocols, IB, Regulatory communication, PV, PD Etc. Record
Maintenance.
Assurance of CT Approvals and CTS in TMF and ISF.
Facility Tours in CTS checking the Basic Facilities in Hospitals having a Clinical Trials.
Communication with Regulatory bodies i.e. DRAP, NBC e.g. Reporting of SAE, AE and progress reports to DRAP, NBC & IRB.. 

Medesins sans frontier MSF 6 june 2021 - 19 june 2021

Internee Auditor (External project)
Worked as an internee Auditor in endTB and endTB-Q trial at 2 sites in Indus Hospital Karachi & Institute of chest diseases Kotri Sindh. 

EDC Software Experience

Medidata- for SDV
 OpenClinca- for SDV
Veidoc- for SDV
Irtone- for randomisation of IPs
Veeva Vault- for management of eTMF

Skills
Full Command on MS Word, Excel and PowerPoint
Language and Communication Skills

Training and Certification

IPPCR NIH Course
85%
ICH-GCP NIDA Certificate
18 Jan 2021 - 18 Jan 2024
ICHGCP-E6 (R2) Training Workshop at DRK pharma Solutions Pvt. Limited.
01-01-2021
Training on COVID-19 Vaccination Phase III CT
Chinese vaccination COVID-19 Phase III Double blind Placebo Controlled Clinical trial Training.
Training on endTB and endTB-Q Clinical Trials
Certification of Audit Training
Training on Electronic Data Capturing (EDC)
Training of Ireton and Viedoc

Projects
Medicated soap Formulation

(Formulation of Medicated Soap on Small)

Assessment of Self-Medication of Sedative and Hypnotic Drugs.

(Report submitted to the department of pharmacy in the form of thesis)

Industrial Exposure
Industrial Exposure
6 Months Experience in NS pharma as a Sterile Area Production Pharmacist.

Visit to Zakfas Pharmaceuticals Multan, For workshop as a part of Sylabus.

Visit to Hamaz Pharmaceuticals Multan, For workshop as a part of Sylabus.

Interests
Research Articles

Social Media
Newspaper
Book Study

Achievements & Awards

Distinction in FSC pre-Medical.

Championship Winner in Cricket On District Level.

Position in Debate speech On Tehsil Level.

Reference

to be furnished on demand