Trusha Komervelliwar
Pune
Summary
Detail-oriented and dedicated Clinical Research Coordinator with 3 years of experience managing and coordinating clinical trials in compliance with Good Clinical Practice (GCP) guidelines and regulatory requirements. Proficient in patient recruitment, data collection, and ensuring protocol adherence to deliver high-quality, accurate trial results. Skilled in building rapport with diverse stakeholders, including investigators, participants, and regulatory agencies, to maintain seamless operations and uphold ethical standards. Currently pursuing an MBA in Healthcare Management to enhance leadership capabilities and strategic decision-making in the clinical research and healthcare sectors.
Overview
3
3
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator
Bharati Hospital and Research Centre
03.2022 - Current
- Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Worked as a study start-up coordinator and participated in the SQV
- Followed informed consent processes and maintained records.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Monitored patient safety throughout clinical trials and reported any adverse events.
- Maintained accurate and up-to-date case report forms and source documents for traceability.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Prepared and maintained regulatory documents for clinical trial submissions.
- Managed patient recruitment, informed consent process and data entry to support trial objectives.
- Monitored unit budget to meet financial objectives for spend rate and funding.
- Mentored and coached new team members, fostering a collaborative and high-performing work environment.
Clinical Research Coordinator Intern
Grapecity Research Solution Pvt Ltd
09.2021 - 12.2021
- Assist in preparing study-related documents such as informed consent forms, case report forms (CRFs), and study protocols.
- Maintain accurate and up-to-date regulatory files and trial documentation.
- Help identify and screen potential study participants based on inclusion and exclusion criteria.
- Schedule appointments and assist in coordinating participant visits.
- Enter data into clinical trial databases, ensuring accuracy and compliance with protocols.
- Help prepare documentation for Institutional Review Board (IRB) submissions.
- Manage study supplies, including lab kits and investigational products.
- Monitor participant safety and report adverse events to the study supervisor.
- Coordinated with investigators, sponsors, and regulatory bodies to facilitate study activities.
Education
MBA - Health Care Management
Manipal Institute of Higher Education
Manipal, India06-2026
PG Diploma - Clinical Research
Lifepoint Institute of Clinical Research
Pune, India12-2021
Bachelor of Technology - Biotechnology
Priyadarshini Institute of Engineering And Technol
05-2021
Skills
- Regulatory Knowledge
- Data Management
- Risk Assessment and Compliance
- Conflict Resolution
- Team Collaboration
- Time Management
- Problem Solving
- Adaptability
- Written Communication
- Technical Proficiency
Certification
- Certified International Council for Harmonization - Good Clinical Practice.
- Certified National Institutes of Health Stroke Scale.
- Certificate of participation in Indian Academy of Neurology Conference 2023
- Certified in Montreal Cognitive Assessment
- Certified in Oxford Cognitive Screening
- Certificate of Participation in Evidence Based Medicine in Health Care Conference 2025
- Certificate of participation in Research Capacity Building Workshop 2024
- Certificate of Participation in Approach to Neurocognitive Disorders RESCON 2023.
- Coursera Certification in Leadership Communication for maximum Impact: Storytelling
- Coursera Certification in Business Statistic and Analysis Capstone.
Languages
English
Upper intermediate (B2)
Marathi
Advanced (C1)
Hindi
Advanced (C1)
Telugu
Beginner (A1)
Timeline
Clinical Research Coordinator
Bharati Hospital and Research Centre
03.2022 - Current
Clinical Research Coordinator Intern
Grapecity Research Solution Pvt Ltd
09.2021 - 12.2021
- Certified International Council for Harmonization - Good Clinical Practice.
- Certified National Institutes of Health Stroke Scale.
- Certificate of participation in Indian Academy of Neurology Conference 2023
- Certified in Montreal Cognitive Assessment
- Certified in Oxford Cognitive Screening
- Certificate of Participation in Evidence Based Medicine in Health Care Conference 2025
- Certificate of participation in Research Capacity Building Workshop 2024
- Certificate of Participation in Approach to Neurocognitive Disorders RESCON 2023.
- Coursera Certification in Leadership Communication for maximum Impact: Storytelling
- Coursera Certification in Business Statistic and Analysis Capstone.
MBA - Health Care Management
Manipal Institute of Higher Education
PG Diploma - Clinical Research
Lifepoint Institute of Clinical Research
Bachelor of Technology - Biotechnology
Priyadarshini Institute of Engineering And Technol
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