SHOBINA THAVASELVAN
Markham,Canada
Summary
Highly knowledgeable Regulatory Affairs Associate with background in the pharmaceutical industries. Comprehensive understanding of FDA regulations, submissions, and compliance procedures. Strengths include strategic planning, problem-solving abilities, and strong communication skills. Previous work resulted in streamlined regulatory processes and improved compliance performance.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Clinical Research Assistant
Lakshman Gunaratnam Lab
01.2021 - Current
- Performed DNA extraction and PCR testing to identify genetic markers in biological samples, ensuring accurate data for regulatory reporting.
- Analyzed gel electrophoresis results to determine the presence of wild-type and mutant alleles, contributing to key research findings and study documentation.
- Maintained and organized research documentation, ensuring data integrity and regulatory compliance by adhering to GCP and ICH guidelines.
- Supported protocol development and documentation preparation, including research summaries and standard operating procedures (SOPs) for study submissions.
- Collaborated with regulatory teams to ensure study compliance, assisting with health authority submissions, document filing, and quality control processes.
Clinical Research Recruiter
BioPharma Services Inc.
05.2024 - 01.2025
- Conducted telephone eligibility screenings for potential clinical trial volunteers, ensuring alignment with inclusion/exclusion criteria.
- Managed regulatory document organization and data entry, ensuring compliance with GCP, ICH, and SOPs.
- Assisted in tracking clinical trial statistics, study documentation, and submission processes for regulatory compliance.
- Coordinated with cross-functional teams to streamline recruitment processes and optimize compliance with study protocols.
- Provided Quality Assurance (QA) support by ensuring accurate documentation, assisting with audits, and maintaining compliance records.
Patient Care Coordinator
Dr. Kugananthy Ravindran
01.2023 - 05.2024
- Scheduled and optimized patient appointments, ensuring an efficient workflow for the dental practice.
- Assisted in treatment coordination, explaining treatment plans and procedures to patients.
- Supported billing, insurance claims, and regulatory documentation to ensure accurate and timely processing.
- Managed electronic health records, ensuring accuracy and compliance with privacy regulations.
- Liaised with patients and insurance providers to streamline administrative workflows and address inquiries.
Administrative Clerk
Rollingstar Freightlines System
04.2020 - 01.2021
- Managed regulatory document organization and compliance tracking for transportation logistics.
- Processed invoicing, expense tracking, and accounts receivable management for company operations.
- Coordinated scheduling, driver assignments, and vehicle maintenance tracking, ensuring operational efficiency.
- Assisted with data entry and maintenance of compliance records, ensuring alignment with industry regulations.
- Supported cross-functional teams in administrative and documentation tasks, improving workflow efficiency.
Education
Master of Management of Applied Science -
University of Western Ontario
London, ON08.2024
Bachelor of Science - Medical Science & Biology
University of Western Ontario
London, ON04.2023
Skills
- Regulatory Submissions & Compliance
- Document & Data Management
- Regulatory Process Support
- Project Coordination & Process Improvement
- Clinical Trial Recruitment & Data Entry
- Quality Assurance & Audit Support
- Cross-Functional Collaboration & Communication
- Proficient in MS Office, Electronic Regulatory Vault (ERV), and Document Management Systems
Accomplishments
- Dean's Honour List
Languages
English
Native/ Bilingual
Tamil
Native/ Bilingual
Certification
- Biosafety
- Laboratory Safety and Hazardous Waste Management
Timeline
Clinical Research Recruiter
BioPharma Services Inc.
05.2024 - 01.2025
Patient Care Coordinator
Dr. Kugananthy Ravindran
01.2023 - 05.2024
Clinical Research Assistant
Lakshman Gunaratnam Lab
01.2021 - Current
Administrative Clerk
Rollingstar Freightlines System
04.2020 - 01.2021
Master of Management of Applied Science -
University of Western Ontario
Bachelor of Science - Medical Science & Biology
University of Western Ontario
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