Clinical Research Data

DR. KINGSTON SAMRAJ KIRUBAKARAN J

DOCTOR OF PHARMACY (PHARM.D)

G-MAIL :****************@*****.*** Address : Thanjavur, Tamilnadu, India Mobile Number : +91-912******* ORCID ID: https://orcid.org/0009-0005-9542-319X Linkedin: https://www.linkedin.com/in/dr-kingston-samraj-kirubakaran-j-873012235 OBJECTIVE

Highly motivated and detail-oriented Pharm.D. graduate with hands-on experience in designing and conducting a randomized controlled trial and monitoring adverse drug reactions (ADRs). Seeking a challenging role in Clinical Research, Pharmacovigilance, or Data Management where I can apply my practical knowledge of clinical protocols, drug safety, and regulatory standards to contribute to evidence-based healthcare and ensure patient safety. Committed to continuous professional development and excellence in research execution and data integrity.

CAREER HIGHLIGHTS

CLINICAL PHARMACIST INTERNSHIP

Thanthai Periyar Government Headquarters Hospital / Erode, Tamilnadu, India Dec 2023 - Dec 2024 ROLE: Monitored adverse drug reactions (ADRs), analyzed medication errors, and conducted prescription auditing to ensure patient safety and compliance with treatment guidelines. Participated in ward rounds, collaborating with healthcare teams to optimize pharmacotherapy. Provided patient counseling on medication adherence, side effects, and proper usage to enhance therapeutic outcomes. AWARD: 4 th National pharmcovigilance week celebration 2 nd prize in the ADR case report intercollegiate oral presentation at J.K.K.Nattraja college of pharmacy. ACADEMIC RESEARCH

J.K.K.Nattraja college of pharmacy / Namakkal, Tamilnadu, India May 2023 - Oct 2023 ROLE: Designed and conducted randomized controlled trials (RCTs), collected and analyzed clinical data, and interpreted results to support evidence-based findings. Developed research protocols, ensured regulatory compliance, and utilized statistical tools for data analysis. Authored manuscripts, synthesizing research findings into high-quality publications for peer-reviewed journals. PHARMACY TRAINEE ASSISTANT

JUN AUSHADHI / Kumarapalayam, Namakkal, Tamilnadu, India Aug 2022 -Aug 2023 Performed safety checks when dispensing medications to ensure accuracy and patient safety. Interpreted, validated, and filled prescription orders while counseling patients on proper medication use, dosage, side effects, and potential interactions. Educated patients and caregivers on drug storage and administration to optimize therapeutic outcomes.

BASIC KNOWLEDGE OF

Clinical Data Management

Basic knowledge of clinical data management, CRF Designing, Clinical Data Management Process Flow

(Study startup, Study conduct, Study close-out), CDM Modules, Case Report Form, Essential Documents and Trial Master File.

Good clinical practice (GCP) : Trial Management and 21 CFR, HIPAA

Data Validation, SAE Reconciliation, Data discrepancy or Query management, Informed Consent Form Process and Patient Recruitment

Clinical Trial Management

Phases of clinical trial- I, II, III and IV

Clinical trial Monitoring (CRA) and Responsibilities of Monitor, CRA, CRC, Investigator, Sponsor

ICH-GCP -13 Core PRINCIPLES

Difference between ICH-GCP and Indian GCP

Informed consent Process, Reporting (AE, SAE)

Schedule Y

Informed consent Process, Reporting (AE, SAE), Case Report form Pharmacovigilance

ADR, Serious Adverse Reaction, SUSAR, SAE, MedDRA, Risk Management, ADR Monitoring, Narrative Reports, SAE Reconciliation.

ICSR, SAE Reporting timelines, ICH- E2a, E2b, E2c guidelines.

PSUR, DSUR, Volume 9A, CIOMS.

Causality Assessment, Signal, Frequency of ADR, De-challenge, Re-challenge PROFESSIONAL EXPERTISE

1. Clinical Research & Trial Management

2. Adverse Drug Reaction (ADR) Reporting

3. Evidence-Based Medicine & Pharmacovigilance

4. Literature Review & Systematic Research

EDUCATION

J.K.K.Nattraja college of pharmacy, Doctor of pharmacy 2018 - 2024 Namakkal, Tamilnadu, India GPA: 3.1/4.0

ADVANCED LEARNING

Advance Post Graduate Program in Clinical Research & Management in 2025 from Clini India Bangalore. SWAYAM

1. Ethics Review of Health Research / CERTIFICATE

2. Scientific Writing in Health Research / CERTIFICATE 3. Introduction to Systematic Reviews for Dental Health Professionals / CERTIFICATE 4. Basic Course in Biomedical Research

COURSERA / LINK

1. Education – 2 Completed

2. Course – 9 Completed

PAPER PUBLICATION

1. RESEARCH - Caffeine's impact on blood glucose level in patients taking anti - diabetic medications for type

- II diabetes mellitus & healthy people: A randomized, open-label, multisite trial (In process with IJPHS Journal) 2. REVIEW - Current Trends In Neurocritical Care: A Comprehensive Review (Published in Journal of neurocritical care Volume number:18 Issue number: 1 2025) 3. REVIEW- Nano particle based therapies in cancer management: From drug delivery to advanced imaging techniques (In process with Indian Journal of Surgical Oncology) 4. REVIEW- Genetic variations in intracranial hemorrhage: insights into acitrom-induced hemorrhage and proteomic approaches to diagnosis (In process with Neurocritical care) 5. META ANALYSIS - Integrating ayurvedic and allopathic treatment in diabetes management: A meta analysis

(Published in Biosciences Biotechnology Research Asia volume number: 21 issue no: 4 2024) 6. RESEARCH - Immediate Glycemic Impact of Caffeine Consumption: A Prospective Analytical Observational Study Comparing Type 2 Diabetic Patients on Metformin with Healthy Individuals (Published in Journal of Neonatal surgery Vol. 14, Issue 6 2025)

CONFERENCES & PRESENTATIONS

1.Kingston, J. (2024, January 6). Caffeine’s impact on blood glucose level in patients taking anti-diabetic medications for Type II Diabetes Mellitus and healthy individuals: A randomized, open-label, multisite trial. Poster presented at the 9th International Conference on Clinical Pharmacy: Advancing Patient-Centric Medication Optimization, Manipal College of Pharmaceutical Sciences, Manipal. 2. Kingston, J. (2022, September 2). Assessment of community pharmacists’ knowledge, attitude, and practice towards medication safety among pregnant women. Poster presented at the 25th Annual National Convention of Pharmaceutical Teachers of India – 2022, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Mysuru.

3. Kingston, J. (2023, August 10). General population’s knowledge, attitude, and practices towards antibiotic use for upper respiratory tract infections: A cross-sectional study. E-poster presented at Innovative Breakthrough in Pharmacare – Nurturing the Future Pharmacists 2023 (IBP-NFP 2023), Vivekanandha Pharmacy College for Women.

EXTRA CURRICULAR ACTIVITIES

Participation in clinical case presentations or journal clubs

Participation in college sports (e.g., football, badminton, athletics, kabaddi, cricket)

Representing college in inter-university tournaments

Participation in quiz competitions

Science or research fairs

Paper or poster presentations

Attendance at workshops or seminars

LANGUAGE

● English (Full Professional Proficiency)

● Tamil (Bilingual Proficiency)

● Hindi (Reading & Speaking Proficiency)

DECLARATION

I, Kingston Samraj Kirubakaran, hereby certify that the above information is true and accurate of my knowledge.

Yours Truthfully,

Dr. Kingston Samraj Kirubakaran J.

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