Divya Bharathi B – Unveiling the Future of Clinical Trials: Meet the Aspiring Research Innovator You Need to Know!

Divya Bharathi B

Professional Summary

Aspiring Clinical Research Associate with hands-on experience in EDC tools (Castor, REDCap), clinical documentation, and simulated trial execution. Familiar with ICH-GCP guidelines, trial phases, and data integrity protocols. Committed to supporting patient safety, regulatory compliance, and the successful execution of clinical trials.

Education

Bharathidasan University, Trichy, Tamil Nadu

B.Tech in Biotechnology CGPA: 8.1 / Percentage: 76.85%

Certifications & Training

Clinical Data Management Certification | Biotecnika (Mar 2025 – Present)

• Used Castor EDC to enter and monitor participant-level clinical trial data.
• Simulated CRF-based data entry including adverse events, consent, vitals, and medical history.
• Ensured data consistency, standard coding (binary/date formats), and basic audit trail review.
• Practiced query generation, form validation, and CRF logic verification.
• Participated in mock team coordination exercises for CDM task delegation.
• Gained working knowledge of REDCap, trial documentation workflows, and ICH-GCP standards.

Certifications:

• Good Clinical Practice (GCP) – NIH (2025)
• Clinical Data Standards (CDASH, SDTM) – Coursera

Clinical Data Projects (Simulation-Based)

• Castor EDC Mock Trial Simulation – 2025
• Simulated full patient entry across CRFs with demographics, history, AEs, and visit schedules.
• Practiced resolving auto-generated queries and reviewed audit trails.
• Understood clinical data flow from subject enrollment to database lock.

Academic Projects

Final Year Project – CSIR-NIIST, Trivandrum (Dec 2024 – Apr 2025)

• Maintained structured research documentation and bioactivity datasets.
• Analyzed data using NMR, FTIR, and Mass Spectrometry.
• Conducted in vitro assays: DPPH, ABTS.

Minor Project – Anna University, Trichy (May – July 2024)

• Conducted molecular docking using AutoDock and validated findings experimentally.
• Organized experimental and computational datasets for reporting.

Internship Experience

• Bharathidasan University, Dept. of Bioinformatics
• Project: Methane Production by Methylotrophic Methanogen
• Handled analytical data using GC instrumentation.
• Maintained lab documentation aligned with SOPs.

Bioinformatics Internship (2023)

• Worked with ligand screening, visualization tools (PyMol, Chimera).

Skills & Tools

Clinical Knowledge & Monitoring

• Knowledge of clinical trials, study designs, and trial phases
• Familiarity with ICH-GCP guidelines and regulatory frameworks
• Understanding of data privacy, integrity, and ethical considerations in clinical research
• Ability to monitor and manage clinical site follow-ups effectively

Clinical Data Management & Compliance:

• Castor EDC (data entry, query simulation, audit trail), REDCap (data collection, form setup)
• Clinical Documentation, CRF Management, ICH-GCP, GMP, GLP, Data Quality Checks
• Query resolution, audit review, CRF validation

Analytical Techniques:

• Chromatography (Column, TLC, GC), Spectroscopy (NMR, UV-Vis, FTIR, MS)
• Bioassays: DPPH, ABTS, FRAP

Bioinformatics & Software:

• AutoDock, PyMol, Chimera, LigPlot+, PubChem, ChemDraw
• Microsoft Excel, Word, PowerPoint

Interpersonal Skills

• Strong attention to detail and accuracy in data handling
• Effective organizational, communication, and leadership skills
• Able to work independently with initiative to resolve problems
• Proven ability to collaborate and maintain professional relationships with coworkers, managers, and clients
• Comfortable with medical terminology and clinical documentation

Declaration

I hereby declare that the above information is true and correct to the best of my knowledge and belief.

Place: Trichy Signature: B. Divya Bharathi

Skills: Clinical Trials, ICH-GCP Guidelines, Data Management, Clinical Documentation, CRF Management, Bioassays, Spectroscopy, Bioinformatics, Microsoft Office, Leadership

“`

Cover Letter:

Divya Bharathi B
Trichy, Tamil Nadu
Subject: Application for the Position of Clinical Research Associate
Dear Hiring Manager, Date: 26.05.2025
I am writing to express my interest in the Clinical Research Associate position at Panacea Medical Technologies Pvt. Ltd. With a strong academic background in Biotechnology and hands-on experience in clinical research simulations, I am excited about the opportunity to contribute to your innovative work in advancing medical technologies.
Through my clinical data management training and simulation-based projects, I have developed practical knowledge of clinical trial processes, including CRF design, data accuracy checks, and mock trial monitoring using Castor EDC and REDCap. My academic and internship experiences have reinforced my skills in documentation, regulatory compliance, and analytical problem-solving. I am well-versed in ICH-GCP guidelines and understand the ethical considerations and data privacy essential to clinical research.
I am particularly drawn to Panacea’s mission of delivering advanced therapeutic solutions, and I am confident that my commitment to precision, teamwork, and continuous learning will allow me to add value to your clinical research operations. I would welcome the opportunity to further discuss how my background aligns with your goals. Thank you for considering my application. I look forward to the opportunity to speak with you.
Warm regards,
B. Divya Bharathi