KOMATHY SELVARAJ
Klang
Summary
Proactive and results-driven Clinical Research professional with 4+ years of experience leading and supporting global Phase I–III trials in haematology and gastroenterology. Currently a Clinical Research Manager, with proven success in managing study start-up, site readiness, monitoring oversight, and regulatory compliance in line with ICH-GCP and international SOPs. Adept at resolving data queries, overseeing clinical documentation, and driving audit-ready quality across multiple sites. Technically skilled in REDCap, EDC, and eISF systems. Recognized for independent leadership, cross-functional coordination, and mentoring junior staff. Now seeking to leverage this experience in a dynamic CRA role focused on quality-driven site monitoring and operational excellence.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Clinical Trial Coordinator
Clinical Research Malaysia
04.2022 - 04.2025
- Worked closely with CRAs and the Regulatory & Start-Up (RSU) team to maintain clinical documents and systems, ensuring site compliance and timely updates.
- Assisted in pre-study, initiation, monitoring, and close-out visits, supporting clinical trial activities from start to finish.
- Ensured timely reporting of adverse events, maintaining patient safety throughout course of trial.
- Managed clinical trial documents, reports, and files according to GCP, ICH guidelines, and company SOPs.
- Handled Investigational Product (IP) storage, dispensing, resupply, and accountability records.
- Processed and prepared lab specimens following central lab requirements for vendor pickup.
- Coordinated and conducted site feasibility assessments with new and potential investigators.
- Reviewed Case Report Forms (CRFs), queries, and clinical data regularly to ensure accuracy and completeness.
- Acted as central contact for project communication, documentation, and team coordination.
- Supported more than 10 Phase I–III clinical trials in haematology, haemato-oncology and gastrology.
Research Officer
National Institute of Health
04.2021 - 03.2022
- Collected and accurately transcribed clinical and survey data into the REDCap electronic database, ensuring data quality and confidentiality.
- Coordinated participant follow-up visits and supported the day-to-day execution of research procedures in alignment with study protocols.
- Monitored study milestones, including regulatory approvals, CRF completion, and resolution of data queries to ensure timely project progress.
- Collaborated with support teams to organize bio-specimen transportation logistics, maintaining proper handling and chain-of-custody documentation.
- Ensured Good Documentation Practices (GDP) and maintained high standards of compliance with GCP and ICH guidelines.
- Assisted during site monitoring visits, ensuring the Investigator Site File (ISF) and regulatory binders were inspection-ready and up to date.
- Performed key laboratory procedures such as:
PBMC isolation, harvesting, and cell count
T-regulatory (T-reg) cell analysis via flow cytometry
Immunoassays using ADVIA Centaur platform
ELISpot assay for immune cell activity. - Transcribed and managed laboratory results in electronic databases for downstream analysis and reporting.
- Managed clinical trial over 1 year.
Research Assistant
Universiti Tenaga Nasional
12.2019 - 02.2020
- Participated actively in regular meetings with fellow researchers to discuss project updates, challenges faced, and lessons learned during ongoing activities.
- Provided support, including data collection, management and analysis, report writing, presentation and review of reports for Sediment Load project.
- Involved in preparing extensive literature reviews and drafting technical reports.
- Identified and resolved data discrepancies, ensuring highest level of accuracy in research outcomes.
- Conducted literature reviews to support hypothesis development and identify gaps in existing knowledge.
Research Officer
Malaysia - Japan International Institute of Technology
12.2014 - 09.2017
- Conducted myriad of laboratory and pilot scale research in collecting experiment data.
- Prepared an array of documents in minutes of meetings as well as standard operating procedures for equipment and experiments.
- Monitored grant allocation status as well as managed transactions and financial reports.
- Constantly kept abreast with latest development and knowledge in the field.
- Performed various administrative functions while assisting in managing grants and coordinating laboratory (i-Kohza) activities as well as MYRA and Laboratory audit documents preparation.
Education
Master of Science - Industrial Science
Universiti Tenaga Nasional
Putrajaya, Malaysia11-2024
Bachelor of Science - Biomedical Science
Universiti Tunku Abdul Rahman
Kampar, Perak, Malaysia01.2014
Skills
- Strong knowledge of ICH-GCP guidelines and Clinical trial phases I–III
- Familiar with Regulatory requirements (local ethics committees)
- Experience with Site monitoring activities: pre-study, initiation, monitoring, and close-out visits
- Skilled in Regulatory documentation, (local ethics committees)on, monitoring, and close-out visits
- Proficient in managing Investigator Site Files (ISF) and maintaining audit-ready site documentation
- Hands-on experience with Specimen handling, PBMC isolation, Flow cytometry, ELISpot, and Immunoassays
- Effective communicator with CRAs, investigators, sit and maintaining audit-ready site documentation
- Proficient in Clinical trial systems: REDCap, EDC (Medidata, Oracle InForm), and eISF platforms
Certification
- Handling/offering for transportation of dangerous goods tested as per 49CFR 172.700/IATA 1.5
- Protocol Compliance Workshop
- GCP MOH Certification in October 2021
- Training To Improve Performance of Study Coordinators
- Sponsor Related Training
- Patient Recruitment & Retention Workshop
- Good Submission Practice Workshop with Malaysia Research Ethics Committee
Languages
English
Proficient
C2
Malay
Proficient
C2
Tamil
Elementary
A2
Publications
- Effect of Thermal Treatment on Diatomite from China, Selvaraj K S, Ming K S, Noor M J M M, Goto M, Kassim M A, Saidi H, Ujang Z, Iyavoo D and Tamunaidu P., FEIIC International Journal of Engineering and Technology, pp. 35-39, 2016
- Characterisation and Application of Diatomite in Water Treatment, Raj K.S., Noor M.J.M.M., Goto M., Tamunaidu P., Proceedings of the Second International Conference on the Future of ASEAN (ICoFA) 2017 - Volume 2, Saian R., Abbas M., Springer, Singapore, pp. 533-539, 2018
- Alternative Approach to Conventional River Water Treatment Using Natural Coagulant, Selvaraj K. Sidek L M, Noor M J M M, Tamunaidu P, Goto M., International Journal of Engineering & Technology, pp. 739-742, 2018
- The Effect of Acid Treatment on Diatomite and Its Application in Treating Semenyih and Langat River Water, Selvaraj K. Sidek L. M, Tamuniadu P., Noor M.J.M.M., Hayder G., Proceedings of the First International Conference on Dam Safety Management and Engineering (ICDSME) 2019, L. Mohd Sidek et al., Springer Nature, Singapore, pp. 341-348, 2020
Awards
- Second Runner-up position for Best Presenter Award, Fourth IWA-UTM International Publication Workshop 'Writing Scientific Papers-Steps towards Successful Publication', Universiti Teknologi Malaysia, 2016
- Chaired a session for oral presentation, The 7th IWA-ASPIRE Conference & Water Malaysia Exhibition, Kuala Lumpur Convention Centre, 2017
Additional Information
- Willingness to Travel: Open to regional and national travel.
- Work Authorization: Eligible to work in Malaysia and applicable region.
REFERENCES
References are available upon request.
Timeline
Clinical Trial Coordinator
Clinical Research Malaysia
04.2022 - 04.2025
Research Officer
National Institute of Health
04.2021 - 03.2022
Research Assistant
Universiti Tenaga Nasional
12.2019 - 02.2020
Research Officer
Malaysia - Japan International Institute of Technology
12.2014 - 09.2017
Master of Science - Industrial Science
Universiti Tenaga Nasional
Bachelor of Science - Biomedical Science
Universiti Tunku Abdul Rahman
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