Summary
Overview
Work History
Education
Skills
Websites
Certification
Accomplishments
Number of visits that have been performed by me yearly:
Therapeutic Expertise
Areas of Interest
My Publications
Training
Languages
Disclaimer
Timeline
Generic

Syed Sufiyan Fazal

Jaipur

Summary

Experienced Senior Clinical Research Associate with expertise in managing and overseeing clinical trials. Possesses extensive knowledge of clinical trial protocols, patient interaction, data management, and regulatory compliance. Demonstrated strong leadership skills and efficiency in monitoring activities related to clinical studies while maintaining high-quality standards for all research projects.

Overview

13
13
years of professional experience
1
1
Certification

Work History

Sr. Clinical Research Associate

Oneiric International’s
Jaipur
10.2022 - Current
  • Identified PI/site for enrollment, assessed manpower need & infrastructure capabilities for timely enrollment
  • Facilitate ongoing communication with PI and study team, actively identifying and resolving challenges
  • Collaborated with various team members and sites to ensure seamless communication and coordination across multiple studies
  • Ensured timely resolution of study-related issues by actively managing reports and trackers, highlighting any red flag concerns
  • Flexible for travel as necessary for studies
  • Executed regional Trial Feasibility's adhering to SOPs.
  • Participated in continuous training on regulations, standard operating procedures, guidelines and trial protocols and procedures.
  • Prepared and customized patient information and consent forms
  • Streamlined partnership with selected sites to complete or coordinate ethics submissions, negotiate trial budgets/contracts, and facilitate regulatory authority clinical trial applications/notifications.
  • Organized and equipped study centers with necessary trial materials and training, supported study sites in creating and implementing recruitment strategies, conducted regular on-site or remote monitoring of the studies.
  • Created comprehensive trial protocols that clearly outlined the purpose, inclusion/exclusion criteria, and methodology
  • Conducted thorough source data/document verification (SDV) to validate the integrity of information recorded on case report forms (CRFs)
  • Managed Clinical Trial Materials (CTM) including accountability, distribution, and logistics at the site.
  • Assisted sites in solving problems related to recruiting, retaining patients, conducting the study, and collecting data.
  • Streamlined the process of safety reporting to ensure efficient communication between sites, actively participated in data management by supporting site staff with data inquiries, and meticulously maintained trial documentation.
  • Expanded database through the utilization of existing contacts from sites, investigators, industry, and vendors.
  • Customized patient information and consent forms to ensure accuracy and compliance
  • Contributed to the preparation of draft SAE final report
  • Completed miscellaneous tasks assigned by management as needed.
  • Educated investigators & clinical research professionals on regulatory updates
  • Performed all activities in strict adherence to ICH E6, Indian GCP, New NDCT 2019, SOPs & relevant regulatory requirements.

Clinical Research Associate-II

Oneiric International’s
Jaipur
04.2021 - 09.2022
  • Performed clinical research activities including protocol development, subject recruitment and data collection.
  • Reviewed and monitored clinical trial sites to ensure compliance with Good Clinical Practices guidelines.
  • Coordinated the submission of regulatory documents to IRBs and ECs and other relevant authorities.
  • Assessed incoming source documentation for accuracy and completeness against case report forms.
  • Ensured proper storage of investigational product at investigator sites per GCP guidelines.
  • Prepared reports summarizing study progress and results for senior management review.
  • Monitored safety events reported during the course of clinical trials in accordance with SOPs.
  • Drafted agendas, minutes and other meeting materials for Investigator Meetings or Advisory Boards.
  • Participated in internal audits related to clinical research operations processes.
  • Adhered to good clinical practices, operating procedures and regulatory requirements.
  • Achieved project-specific quality and performance standards and provided documentation and communication.
  • Provided training on GCP standards to new personnel or existing staff members.
  • Maintained accurate records of all regulatory submissions, correspondence and approvals received from local ethics committees or regulatory agencies.
  • Supported quality control program by scheduling site assessment visits for project and conducting monitoring visits.

Clinical Research Associate-I

Oneiric International’s
Jaipur
04.2019 - 04.2021
  • Successfully oversaw the implementation of a oncology trial as well as several studies in general medicine and dermatology. Fostered strong teamwork and effective communication with research staff to meet ICH-GCP guidelines and study protocol requirements.
  • Managed Ethics and Regulatory Submissions, diligently monitoring progress and study approvals.
  • Managed trial training for multiple sites, ensuring protocol adherence and effective communication. Addressed project expectations and resolved any issues that arose.
  • Effectively oversaw the progression of assigned studies through efficient tracking of regulatory/ IEC submissions and approvals, recruitment and enrollment processes, CRF completion and submission procedures, along with data query generation and resolution.
  • Verifying that data entered on to CRFs is consistent with participant clinical notes (source data/ document verification).
  • Filing and collating trial documentation and reports.
  • Evaluates quality and integrity of trial site practices related to proper conduct of protocol and adherence to applicable regulations.

Site Coordinator

S.M.S. Medical Hospital
Jaipur
09.2013 - 03.2019
  • Ensured accurate tracking and upkeep of site status.
  • Performed detailed assessments of Site Trial Master files to optimize documentation quality.
  • Conduct Clinical Study Visits Site Monitoring Visits with monitors.
  • Managed multiple quality audits, consistently meeting expectations and avoiding any major findings.
  • Management of Clinical Trial Sites.
  • Identification and reporting of PDs/ AEs/SAEs.
  • Perform site-level reconciliation of study material (including the IP).
  • Managed finance reconciliation at the site level involving subject-wise payments to the site along with EC submission and amendment submission payment.
  • Maintained subject adherence to study protocols and regulatory guidelines.
  • Coordinated query resolutions with scheduled timelines.
  • Ensured timely EC submissions by prompting sites both before study initiation and on a regular basis throughout the study per project requirements.
  • Maintained proper storage conditions for IMP as per protocol guidelines while monitoring its accountability.
  • Maintained adequate supply of lab kits and equipment for seamless execution of trial activities at the site.

Lecture

Sadbhavna College of Management and Technology
Raikot, Ludhiana
07.2011 - 06.2012
  • Facilitated interactive lectures, seminars, and tutorials.
  • Guided students through an advisory role, providing support and assistance.
  • Participated in independent research initiatives and positively impacted the institution's overall research standing.
  • Created and edited research materials for publishing.
  • Provided guidance and support for student-led research activities.
  • Ensured ongoing development of skills and knowledge through effective training.
  • Maintained a high level of understanding among departmental faculty and staff regarding their obligations to adhere to university policies and procedures.
  • Managed the provision of necessary systems access to enable effective completion of job duties by department employees.
  • Evaluated student performance through tests, quizzes, presentations, projects, or other assessments.
  • Involved in departmental activities such as curriculum development, faculty meetings, advising sessions.
  • Served as a guest lecturer at other universities or organizations when requested.

Education

Post Graduate Diploma in Clinical Research Operations And Pharmacovigilance - Clinical Research

Indian Institute of Clinical Research
Jaipur
08-2013

Bachelor of Science - Pharmacy

Jaipur National University
Jaipur
04-2011

GED -

M.H.S. School (Rajasthan Board)
Jaipur
05-2006

High School Diploma -

Manoj Public School (Rajasthan Board)
Jaipur
05-2004

Skills

  • Operational Activities
  • Project management
  • Proficiency in Microsoft Office
  • Time Management
  • Critical Thinking & Decision-making
  • Creative Problem Solving
  • Leadership & Teamwork
  • Adaptability & Flexibility

Websites

Certification

  • St John’s Ambulance Senior First Aid Certificate – 2002
  • Participation Certificate In Leprosy Eradication Drive – 2004-2005
  • Certificate of Participation Technorazz, JNU Jaipur-2011

Accomplishments

  • Clinical trial protocol and IB training for Head & Neck Cancer, Breast Cancer, Renal Cell Cancer, Colorectal Cancer, Lung Cancer, Type 2 DM, Osteoporosis, Hepatitis B, C Hepatitis Adult & Pediatric patients, Hypovolemic Shock, Acute Ischemic Stroke, Alzheimer’s Disease and Spinal Cord Injury Baby Care Product, Influenza-like-illness symptoms.
  • As CRC I assisted site PI for patient consent & enrolled more than 300 patients in the studies, without any loss to follow-up.
  • Registration of Ethics Committees:

Number of visits that have been performed by me yearly:

· Site selection visits/ Site qualification visits: 120

· SIV: 96

· SMV: 132

· SCOV: 24

Therapeutic Expertise

  • Oncology, Head & Neck, Breast, Renal Cell, Colorectal, Lung Cancer, Biosimilar, Phase III & IV, CDSCO, Monitor
  • Endocrinology, Type 2 DM, GLP-1, Phase III & IV, CDSCO, Monitor
  • Gastroenterology, Hepatitis B, C, Phase III & IV, CDSCO, Monitor
  • Ophthalmology, AMD, Cataract Surgery, Phase III & IV, CDSCO, Monitor
  • General Medicine, Bacterial Infections, Post Marketing Surveillance, CDSCO, Monitor
  • Emergency Medicine, Hypovolemic Shock, Phase III & IV, CDSCO, FDA, Monitor
  • Pediatric, Baby Care Product, Influenza-illness, Phase III & IV, CDSCO, Monitor
  • Dermatology, Atopic Dermatitis, Phase III, CDSCO, Monitor
  • Neuro/Psychiatric, Acute Ischemic stroke, Alzheimer, Phase III & IV, CDSCO, FDA, CRC
  • Oncology, Metastatic Breast, Prostate Cancer, Phase III, CDSCO, FDA, CRC
  • Diagnosis, VRP 1620, Phase III & IV, CDSCO, CRC
  • Gynecology, Contraceptive Device, Endometriosis, Phase III & IV, CDSCO, CRC
  • Endocrinology, Diabetic Foot Ulcer, Phase III, CDSCO, CRC
  • General Medicine, Anal Fissures Acne Vulgaris., Phase IV, CDSCO, CRC
  • Respiratory, Palmoplantar Pustulosis, Phase II, CDSCO, CRC

Areas of Interest

Clinical Research Operations - Sr. CRA / Trial Specialist / Team Lead Job roles.

My Publications

  • Https://www.researchgate.net/profile/Rajeev-K-Singla/publication/233781225_Isolation_of_3-n butyl_Phthalide_Sedanenolide_from_Apium_graveolens_Linn/links/0fcfd50b72563ea11d000000/Isolation Of-3-n-Butyl-Phthalide-Sedanenolide-from-Apium-graveolens-Linn.pdf
  • Http://iglobaljournal.com/wp-content/uploads/2012/05/3.-Fazal-Singla-2012.pdf
  • Http://www.ijrpc.com/files/32-328.pdf
  • Http://www.webmedcentral.com/article_view/3413
  • Http://www.webmedcentral.com/article_view/3447

Training

  • Participated in the training program on Project Coordination and Management, ICH-GCP and Drug Development, Standard Operating Procedures, Site Management Logistics, Soft Skills, Organizational policies., Clinical trial protocol and IB training for Head & Neck Cancer, Breast Cancer, Renal Cell Cancer, Colorectal Cancer, Lung Cancer, Type 2 DM, Osteoporosis, Hepatitis B, C Hepatitis Adult & Pediatric patients, Hypovolemic Shock, Acute Ischemic Stroke, Alzheimer’s Disease and Spinal Cord Injury Baby Care Product, Influenza-like-illness symptoms.,
  • GCP Training done through NIDA Clinical Trail Network.,
  • The National Institutes of Health (NIH) Office of Extramural Research - successfully completed the NIH Web-based training course "Protecting Human Research Participants".

Languages

Hindi
First Language
English
Advanced (C1)
C1

Disclaimer

I hereby declare that all the statements made above by me are complete and correct to the best of my knowledge and belief.

Timeline

Sr. Clinical Research Associate

Oneiric International’s
10.2022 - Current

Clinical Research Associate-II

Oneiric International’s
04.2021 - 09.2022

Clinical Research Associate-I

Oneiric International’s
04.2019 - 04.2021

Site Coordinator

S.M.S. Medical Hospital
09.2013 - 03.2019

Lecture

Sadbhavna College of Management and Technology
07.2011 - 06.2012

Post Graduate Diploma in Clinical Research Operations And Pharmacovigilance - Clinical Research

Indian Institute of Clinical Research

Bachelor of Science - Pharmacy

Jaipur National University

GED -

M.H.S. School (Rajasthan Board)

High School Diploma -

Manoj Public School (Rajasthan Board)

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Syed Sufiyan Fazal