PREETHA VINOTHKUMAR
Chennai
Summary
Dynamic Clinical Researcher with extensive experience at ICON plc, excelling in regulatory compliance and documentation management. Proven ability in patient recruitment and stakeholder collaboration, ensuring seamless trial execution. Skilled in ICH-GCP guidelines and eTMF management, driving project success and enhancing communication across teams. Passionate about advancing clinical research.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Clinical Trial Assistant
ICON plc
Chennai
08.2023 - 06.2025
- Facilitated compliance with protocols and regulatory requirements in clinical trials.
- Maintained and organized clinical trial documentation, including essential regulatory submissions.
- Collaborated with cross-functional teams to enhance communication and streamline trial execution.
- Supported preparation of study materials such as informed consent and case report forms.
- Tracked and reported clinical trial metrics and milestones for project oversight.
- Ensured timely provision of required trial documents to investigational sites.
- Managed eTMF for the study, performing quality checks on documentation accuracy.
- Provided administrative support to CTM/CRA, enhancing trial progress tracking and data management.
Clinical Research Coordinator
Dr. V. Balaji & Dr. V. Seshiah Diabetes Care & Research Institute
Chennai
01.2022 - 07.2023
- Oversaw end-to-end coordination of both investigator-initiated and sponsor-driven studies.
- Supported AE/SAE reporting per protocol and ICH-GCP guidelines.
- Key Study: C-peptide, HbA1c & Microalbuminuria Correlation in Indian T2DM Patients
Clinical Trial Coordinator
Cancer Institute (WIA)
Adyar, Chennai
02.2019 - 01.2022
- Recruited and screened oncology patients while ensuring accurate data entry for CRFs and eCRFs.
- Maintained drug accountability and site files, coordinating updates with sponsors and monitors.
- Obtained informed consent and scheduled patient visits, managing biosample logistics efficiently.
- Executed management of logs related to biosamples and patient interactions for SPT Study.
Patient Care Coordinator
Tata Consultancy Services (Deployed at Cancer Institute – WIA)
09.2018 - 02.2019
- Supported outpatient navigation, maintained patient records, and assisted with research coordination.
- Acted as a liaison between research staff and patients, ensuring smooth study flow.
Education
B.Sc. - Psychology
Dr. MGR Janaki College, University of Madras
Chennai01.2018
HSC (XII) -
St. Anne’s Girls’ Hr. Sec. School
Chennai01.2015
SSLC (X) -
St. Anne’s Girls’ Hr. Sec. School
Chennai01.2013
Skills
- Clinical Trial Coordination & Documentation
- ICH-GCP & Regulatory Submissions
- Informed Consent Process & AE/SAE Reporting
- Site Start-Up & Monitoring Support
- EDC Systems
- REDCap
- ETMF
- MS Office
- Patient Recruitment & Screening
- Internal Audit & QC Support
- Communication & Stakeholder Collaboration
- MS Office Suite
- Adobe Photoshop
Certification
- ICH-GCP Certification – NIDA Clinical Trials Network
- GCP Workshop – Novartis Healthcare Pvt. Ltd.
- Diploma in Business Computing
- Workshop on Basic Counseling & Psychotherapy
Languages
- English
- Tamil (Fluent in Written & Verbal)
Personal Information
- Date of Birth: 04/24/98
- Nationality: Indian
- Marital Status: Married
Projects And Internship
- SPT Study (Phase IIb/III), HNSCC patient trial with curcumin + metformin
- Diabetes with Nephropathy, Internal-funded observational study
- Intern, Counseling Support, Anbagam Rehabilitation Centre (TERDOD), 05/01/16 – 06/30/16
Timeline
Clinical Trial Assistant
ICON plc
08.2023 - 06.2025
Clinical Research Coordinator
Dr. V. Balaji & Dr. V. Seshiah Diabetes Care & Research Institute
01.2022 - 07.2023
Clinical Trial Coordinator
Cancer Institute (WIA)
02.2019 - 01.2022
Patient Care Coordinator
Tata Consultancy Services (Deployed at Cancer Institute – WIA)
09.2018 - 02.2019
B.Sc. - Psychology
Dr. MGR Janaki College, University of Madras
HSC (XII) -
St. Anne’s Girls’ Hr. Sec. School
SSLC (X) -
St. Anne’s Girls’ Hr. Sec. School
Similar Profiles
Madison FavaMadison Fava
Client Services Associate II at Icon PLCClient Services Associate II at Icon PLC
Karolina ŻukKarolina Żuk
Central Monitoring Associate (dual role with SCRA) at ICON plcCentral Monitoring Associate (dual role with SCRA) at ICON plc
SRIJITH MSRIJITH M
Senior Software Developer at ICON PLCSenior Software Developer at ICON PLC
R. Kishore KumarR. Kishore Kumar
Vice President at RBS Business Services Pvt. LtdVice President at RBS Business Services Pvt. Ltd
Kaviya G SKaviya G S
Associate Consultant at Atos Global IT SolutionsAssociate Consultant at Atos Global IT Solutions