Clinical Research Coordinator (GCP)

MOHD SHAHID ARSHAD

Jamia Nagar, Okhla, New Delhi ************@*****.*** 828-***-**** linkedin.com/in/Mohd-Shahid-Arshad CARRER OBJECTIVE

M. Pharma graduate with 3+ years of experience as a Clinical Research Professional, specializing in site management and patient recruitment. Proficient in managing ISF, supporting study start-up and monitoring visits, and handling essential documents. Skilled in conducting interventional trials and observational studies across multiple indications, ensuring quality, accuracy, adherence to GCP, and regulatory compliance. Eager to contribute to organizations that value innovation and professional growth. PROFESSIONAL EXPERIENCE

Clinical Research Assistant August 2025 – Present

Fortis Memorial Research Institute, Gurugram, Haryana Clinical Research Coordinator January 2023 – August 2025 Medanta Institute of Education and Research (MIER), Medanta – The Medicity, Gurugram, Haryana

Managed clinical trial activities from start-up to close-out, ensuring compliance with GCP standards, NDCT Rules, and regulatory requirements. Coordinated site visits, recruitment, consent, and data management while maintaining trial documentation and collaborating with sponsors and CROs for effective trial execution. Supported budgeting, invoicing, CTA execution, monitoring, and close-out activities.

Managed clinical trial activities from start-up to close-out, ensuring compliance with GCP standards, NDCT Rules, 2019, and regulatory requirements.

Coordinated site feasibility, selection, qualification, and initiation visits (SSV, SQV, SIV) and site monitoring visit, Managing site monitoring visits, and study close-out activities.

Maintained Investigator Site Files to ensure inspection readiness and regulatory compliance.

Managed subject files, ensuring accurate documentation and data integrity as per ALCOA+ principles and compliance with study protocols and regulatory standards.

Screened, recruited, and followed up with study subjects while overseeing consenting, enrollment, and retention processes.

Ensured timely and accurate data entry in EDC/PRO, maintaining consistency with source documents, trial logs, and subject tracking.

Maintained key study logs (e.g., Site Visit, Protocol Training, AE/SAE, IP Accountability, and Subject Logs) and generated Notes to File for deviations. Designed source documents per protocol to ensure accurate data collection.

Handled essential documentation, including Clinical Trial Agreements (CTA), Investigator Undertaking, and Informed Consent Documents (ICD)

Collaborated with sponsors, CRAs, and CROs for effective communication and site- sponsor coordination.

Managed IRB/EC communication for submissions, notifications, approvals, annual reports, and recommendations.

Managed protocol deviations, and ensured SAE/AE reporting and CIOMS submissions in compliance with GCP and NDCT Rules, 2019.

Supervised and performed IP management, sample processing, shipment logistics, and research pharmacy compliance

Maintained research pharmacy logs and ensured compliance with study protocols and regulatory requirements.

Assisted with budget preparation, invoicing, and CTA execution

Registered investigator on SIP and SUGAM platforms, ensuring seamless onboarding and compliance and Registered studies on CTRI.

Coordinated with ICMR for the National Registry of COVID-19 and CSR public health surveys on research projects, including "Anaemia Mukt Haryana. SKILLS

Learning Attitude

Hardworking

Collaborative Team Work

Critical thinking skills

Time management skills

Problem Solving

Planning and Coordination

Attention to detail

TECHNICAL SKILLS

Basic Software Skills

Google tools and Microsoft

365 (Word, Excel,

PowerPoint, Outlook,

Teams), Basic SPSS

Electronic Software

Handling

EHIS: Electronic Health

Information System

(eHIS)

CRMS: Clinical Research

Management System

EDC: Medidata (Rave),

Clinion, RDC (Oracle),

Octalsoft, RedCap

IWRS: Almac, Yprime,

IMPALA, Clinion,

Signant Health, ERT

E PRO: Clario, RWS

Others: Site Investigator

Platform (SIP), Labcorp

Bibliographic Online

Database Search

Literature Survey using

PubMed, Cochrane, Science

Direct, Google Scholar and

CTRI

Pharmacy Practice Skills

Patient Counselling,

Medication Error,

Comprehensive Medication

Review, Data Collection,

Dispensing of Medication,

ADR Monitoring &

Reporting, Prescription

Review, Hospital Drug

Formulary, Therapeutic

Drug Monitoring, Auditing

of Medication

INTERSHIP EXPERIENCE

Clinical Research Intern September 2022 – December 2022 Fortis Escorts Heart Institute and Research Centre, Okhla Road, New Delhi Clinical Researcher April 2022 – July 2022

HAH Centenary Hospital, HIMSAR, Jamia Hamdard, New Delhi PUBLICATION

Arshad, M.S., Garg, A., Khan, M.A. et al. Comparing the Effect of Total Intravenous Anesthesia Versus Inhalational Anesthesia on Patient Quality of Recovery, Cognitive Status & Pain After Undergoing Elective Laparoscopic Cholecystectomy. SN Compr. Clin. Med. 7, 278 (2025). https://doi.org/10.1007/s42399-025-02045-5 EDUCATION

Master of Pharmacy in Pharmacy Practice, Jamia Hamdard 2020 – 2022 Bachelor of Pharmacy, Innovative College of Pharmacy 2016 - 2020 RESEARCH TRAINING

Good Clinical Practice (GCP), National Institute of Drug Abuse (NIDA) Clinical Trials Network, NIH – 2026

New Drug and Clinical Trial (NDCT) Training – 2025

Introduction to the Principles and Practice of Clinical Research 2023-2024, National Institutes of Health, Office of Clinical Research Education and Collaboration Outreach

RESEARCH STUDIES

S. No. Indication Phase Designation

1. Relapsed or Refractory Multiple Myeloma III, I/II Study Coordinator 2. Primary Myelofibrosis III Study Coordinator

3. Critical Care (Anticoagulant and Antiplatelet) I Research Coordinator & Pharmacist 4 Gastroenterology (NAFLD) IV Research Coordinator & Pharmacist 5. Respiratory (Viral Lung Infection) III Research Coordinator & Pharmacist 6. National Registry of COVID-19 Observational Study Coordinator 7. Herpes Zoster Observational Study Coordinator

8. Cardiology (Aortic Valve Bio Prosthesis Registry) Observational Study Coordinator 9. Anaemia Mukt Haryana Public Health Project Coordinator EXTRACURRICULAR ACTIVITIES

National Pharmacovigilance Week at HAH Centenary Hospital

National Pharmacy Week- ADR reporting awareness drive in association with SPER Department of Pharmacology Jamia Hamdard and Miracle Happen Foundation

Patient Advocates for Clinical Research Education and Regulatory Frameworks (PACER Workshop-1) - Awareness of Clinical Research held at Medanta -The Medicity on 31 March 2023

Patient Advocates for Clinical Research Education and Regulatory Frameworks (PACER Workshop- 4) - Awareness of Clinical Research held at Medanta -The Medicity on 29 January 2024 DECLARATION

I hereby declare that all the information furnished above is true, to the best of my knowledge and belief.

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