AKSHAYA RANGAN CHILWARWAR
Kitchener,Canada
Summary
Skilled Clinical Research professional with 4 years of global experience (Canada & Poland, remote) as a Clinical Trial Associate in the Clinical Operations department. Experienced in clinical trial management, regulatory documentation, data management, and cross-functional coordination. Seeking a challenging position where I can leverage my expertise and creativity to contribute to clinical research excellence while continuing to grow professionally. Committed to delivering accurate, compliant, and high-quality work with integrity and dedication.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Clinical Trial Associate
JSS Medical Research
09.2024 - Current
- Clinical Trial Management: Supported Phase I–IV clinical studies from initiation to close-out, ensuring compliance with ICH-GCP, Health Canada, and sponsor requirements.
- Trial Master File (TMF) Management: Ensured accurate and timely filing of essential study documents (e.g., protocols, investigator brochures, ethics committee approvals) in accordance with ICH-GCP and Health Canada regulations.
- Regulatory and Site Documentation: Ensured collection of site-specific regulatory documents and monitored investigator site readiness.
- Data Management and EDC Support: Provided EDC access to site personnel, resolved system-related issues, and ensured timely and accurate data entry compliance.
- Systems & Study Tools: Proficient in study protocols, informed consent forms (ICFs), EDC platforms, IWRS, and other study-specific systems.
- Quality Assurance and Compliance: Assisted with internal and external audits and supported CAPA resolutions.
- Patient and Site Engagement: Supported patient recruitment and retention tracking, managed site payments, and facilitated effective communication between sponsors, CROs, and sites.
- Cross-Functional Coordination: Reduced study timelines by effectively coordinating efforts between cross-functional teams and external vendors.
Clinical Trial Assistant
JSS Medical Research Asia Pacific
11.2020 - 08.2024
- Prepared Minutes of Meeting and assisted the study team with accurate visit reports.
- Maintained study documentation, including Trial Master File (TMF/eTMF), study trackers, and software systems (Outlook, eTMF, SharePoint, OneDrive, DMTL, EDC, IWRS, ELMS).
- Supported site readiness by following up with sites for regulatory documents and ensuring all study initiation documentation was complete.
- Assisted the study team in tracking patient enrollment, study progress, and ensuring timely, accurate, and complete data collection and submission.
- Supported Project Manager and study team in all project aspects, including protocol compliance, FDA/GCP regulations, and site visits as directed by Sponsor/CRO.
- Assisted monitors in managing study supplies and audit preparation for Health Canada inspections.
Quality Assurance Officer
S.D. Fine Chemicals PVT. LTD
02.2019 - 07.2020
- Managed customer complaints and resolved technical queries in coordination with the technical department.
- Prepared and maintained documentation, including SOPs, new product specifications, and standard test procedures.
- Supported Quality Management System (QMS) activities, including change control and deviation management.
Trainee, Jr.Research Associate
Wockhardt Research Centre
07.2017 - 04.2018
- Conducted forced degradation and photostability studies of Insulin and its analogs.
- Gained hands-on experience with UPLC and HPLC (Waters Acquity) systems.
- Project Trainee: Developed HPLC-UV method for determination of Sudan dyes in tomato ketchup at Reliable Analytical Laboratory, Thane.
Education
Post-Graduate Degree Certificate - Health Informatics
Humber Institute of Technology And Advanced Learning
Toronto02-2026
Post-Graduate Degree Certificate - Clinical Research
Conestoga College Institute of Technology And Advanced Learning
Kitchener06-2025
Master of Science - Biotechnology
Kelkar College
Mumbai Maharashtra01-2017
Skills
- Clinical Trial Systems & Tools: EDC, IWRS, eTMF, SharePoint, OneDrive, DMTL, ELMS; site trackers and study software management
- Regulatory & Compliance: ICH-GCP, FDA guidelines, Health Canada regulations, Declaration of Helsinki; Trial Master File (TMF/eTMF) management, site initiation, and regulatory document tracking
- Data Management & Health Informatics: Study database management, patient data entry and validation, data query resolution; Python (Jupyter Notebook), R (Posit Cloud); understanding of Health IT systems and data interoperability principles
- Documentation & Reporting: Preparation of visit reports, minutes of meetings, CAPA support, and audit preparation
- Project & Operational Support: Coordination of site payments, lab activities, meetings, and training sessions; supporting cross-functional teams to ensure timely study deliverables
- Software & Productivity Tools: Advanced Microsoft Office (Word, Excel, PowerPoint); other clinical and data management platforms
- Strong interpersonal and communication skills; effective liaison between sponsors, CRAs, site staff, and cross-functional teams
- Organizational and multitasking skills: managing multiple studies, timelines, and documentation accurately
Accomplishments
- Successfully supported a Health Canada audit with minimal findings, demonstrating strong regulatory compliance and documentation skills.
- Completed 3 internal audits on study TMFs, ensuring 100% compliance and accuracy.
LANGUAGES
English, Marathi, Hindi: First Language
English: C2 Proficient
Certification
NIDA GCP certificate
Timeline
Clinical Trial Associate
JSS Medical Research
09.2024 - Current
Clinical Trial Assistant
JSS Medical Research Asia Pacific
11.2020 - 08.2024
Quality Assurance Officer
S.D. Fine Chemicals PVT. LTD
02.2019 - 07.2020
Trainee, Jr.Research Associate
Wockhardt Research Centre
07.2017 - 04.2018
Post-Graduate Degree Certificate - Health Informatics
Humber Institute of Technology And Advanced Learning
Post-Graduate Degree Certificate - Clinical Research
Conestoga College Institute of Technology And Advanced Learning
Master of Science - Biotechnology
Kelkar College