Vinay Varad
24 Thistlewaite crescent ,ON
Summary
- 03+ years of working experience in the field of Clinical Research with outstanding ability to carry out site visits and data capture activities as per the protocol.
- Skilled in conducting informed consent process, protocol-specific procedures and proficient in data management software and electronic data capture systems.
- Demonstrated ability to coordinate and manage multiple clinical trials, ensuring adherence to protocols and ethical guidelines.
- Proven track record of accurately processing documentation through the Institutional Review Board (IRB) and maintaining comprehensive study-related documentation.
- Strong background in utilizing diverse EDC databases such as Medidata Rave, Redcap, Veeva- Vault, Inform and IWRS/IXRS.
- Adept in applying in-depth knowledge of ICH-GCP, TCPS, 21 CFR Part 11, HC Division – 5, organization SOPs and US FDA safety reporting and guidelines.
- Strong Therapeutic Expertise and Medical Terminology knowledge. Excellent communication and collaboration skills to effectively work with study sponsors, investigators, and staff members.
- Committed to participant safety and meticulous data management.
- Proficient in MS Office (Word, Excel, and PowerPoint) and efficient in oral and communication skills.
Overview
9
9
years of professional experience
Work History
Senior Clinical Research Coordinator
Dr. Fadia El Borkey Medicine Professional Corporation
03.2021 - Current
- Managed and coordinated multiple clinical trials in strict adherence to GCP guidelines, ensuring protocol compliance, participant safety, and study timelines
- Oversaw participant recruitment, screening, and enrollment processes, ensuring compliance with inclusion/exclusion criteria and addressing participant concerns during informed consent procedures
- Developed and maintained accurate and complete study-specific documents, including protocols, case report forms, and regulatory submissions
- Collaborated with study sponsors, investigators, and team members, fostering effective communication to resolve study-related issues
- Expertly executed protocol-specific procedures, including vital sign assessments, EKGs, and blood sample collection and ability to onboard new staff and track trainings
- Ensuring equipment calibration and yearly maintenance are performed according to Site SOP
- Conducted study visits as per schedule, performed protocol-specific procedures, and diligently entered data using electronic capture systems
- Managed study supplies, investigational products, and equipment, maintaining accurate inventory and proper storage.
Clinical Quality Control Assistant
Pharma-Medica Research Inc
05.2017 - 08.2017
- Provided support to the Clinical Research Coordinator in the execution of clinical trials, including participant recruitment, data collection, and administrative tasks
- Maintained accurate and organized study records, ensuring data integrity and confidentiality
- Assisted in preparing study-related documents, including informed consent forms, study protocols, and case report forms
- Ensure study related document were completed that they are accurate and legible according to regulations.
Clinical Research Intern
HSK
07.2015 - 10.2016
- Assisted the Clinical Research Coordinator in the execution of clinical trials, ensuring compliance with study protocols and regulatory guidelines
- Assisted in data collection, entry, and quality control checks to ensure data integrity
- Collaborated with the research team to ensure smooth study operations and effective communication
- Maintained accurate and organized study documentation, including participant records, study logs, and regulatory binders.
Education
Doctor of Pharmacy (Pharm-D) -
RGUHS
India08.2015
Post graduate Diploma in Clinical Research -
Oxford College of Arts, Business, And Technology
Canada08.2017
Skills
- Informed Consent Process
- GCP Knowledge
- Patient recruitment
- Adverse event reporting
- Data Collection
- Participant screening
Clinical Trial Experience
- Asthma Study
- Diabetes Study
- Post-menopausal Study (Hot Flush)
- Endometriosis Study
- Chronic Kidney Disease Study
Professional Highlights
- ICH GCP certification
- TCPS 2 Certification
- IATA Certification
- Phlebotomy Certification
- HC- Food and Drug Act, Part C- Div-5 certification
Personal Information
Title: Experienced Clinical Research Coordinator
References
Available upon Request
Languages
English
Full Professional
Timeline
Senior Clinical Research Coordinator
Dr. Fadia El Borkey Medicine Professional Corporation
03.2021 - Current
Clinical Quality Control Assistant
Pharma-Medica Research Inc
05.2017 - 08.2017
Clinical Research Intern
HSK
07.2015 - 10.2016
Doctor of Pharmacy (Pharm-D) -
RGUHS
Post graduate Diploma in Clinical Research -
Oxford College of Arts, Business, And Technology
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