Clinical Trial Research

Naresh Kunchala

+1-937-***-**** ***********@*****.*** https://www.linkedin.com/in/naresh-kunchala-6822981a2 EDUCATION

Boonshoft School of Medicine, Dayton, OH Aug 2023 - Dec 2024 MS, Pharmacology and Toxicology & Clinical Trial Coordination Certification

• GPA: 4.0

Samskruti College of Pharmacy, Telangana, India Aug 2017 - Jul 2023 Doctor of Pharmacy (Pharm D)

• GPA: 3.0

WORK EXPERIENCE

Wright State Physicians, Pharmacology Translational Unit Aug 2024 - Dec 2024 Clinical Trial Coordinator Intern Dayton, OH

• Managed Phase 2 and 3 trial operations, ensuring compliance with GCP, IRB regulations, and CTMS.

• Recruited participants for Atopic Dermatitis and Hidradenitis Suppurativa trials through EMR review.

• Conducted participant screenings and obtained informed consent in adherence with IRB-approved protocols.

• Utilized REDCap and Microsoft Office for data entry and management, ensuring data integrity and accuracy.

• Assisted with drug administration, biospecimen collection, processing, shipping, and documentation. Kamineni Academy of Medical Sciences and Research Centre Jul 2022 - Jul 2023 Clinical Research Assistant Intern Hyderabad, Telangana, India

• Supported Phase 1 and 2 clinical trials on COPD and wounds, ensuring compliance with CDSCO, ICH E6(R2), and GCP guidelines while contributing to data collection and report preparation.

• Recruited eligible subjects, coordinated site activities, and managed biological specimens.

• Maintained accurate case report forms and electronic data capture documentation through meticulous data cleaning.

• Managed drug accountability, storage, and dispensing of investigational products. Samskruti College of Pharmacy & KAMSRC Aug 2021 - Jun 2022 Clinical Research Project Coordinator Hyderabad, Telangana, India

• Designed and conducted a clinical study on the efficacy and safety treatments in pediatric patients with Bronchopneumonia.

• Developed a research protocol and obtained IEC approval, enrolled 116 patients through ICF.

• Randomized participants, administered study drugs per protocol & conducted safety lab assessments.

• Analyzed data using advanced data analysis techniques (SPSS), and presented findings to the IEC. Anurag Ortho Neuro and Multi-Specialty Hospital May 2022 - Jun 2023 Volunteer: Clinical Pharmacologist Hyderabad, Telangana, India

• Conducted patient history assessments, vital sign monitoring, blood collection, prescription audits, and ADR evaluations.

• Educated patients on diseases, medications, and lifestyle modifications. Skills

• Clinical Skills: CPR, Protocol Reviews and Amendments, Patient Recruitment, Screening, Informed Consent, Randomization EKG, Adverse Event Monitoring, Phlebotomy, Electronic Medical Records (EMR/EHR) Review, Case Report Forms (CRF), Electronic Data Capture (EDC), IRB Submissions, IND Safety Forms

• Technical Skills: Microsoft Office, MATLAB, SPSS, REDCap, GraphPad Prism, Minitab, Adobe

• Analytical & Research Skills: Data Collection, Data Analysis, Data Cleaning, Report Writing, Grant Proposal Writing, Interview Administration, Participant Scheduling, Study Documentation

• Soft Skills: Organizational Skills, Strong Communication, Detail-Oriented, Team Collaboration and Leadership, Problem-Solving, Adaptability, Emotional Intelligence, Interpersonal Rapport CERTIFICATIONS

• Certifications: BLS/CPR, Clinical Trial Coordination, Lean Six Sigma Green Belt, IATA Dangerous Goods, Good Clinical Practice

(GCP), HIPAA, OSHA Bloodborne Pathogens, IRB Vulnerable Populations Biomedical. PROJECTS & PUBLICATIONS

• Comparative Study on Bronchopneumonia Treatments. WJAHR (Vol. 7, Issue 9, 2023)

• Review on Urinary Biomarkers for Diabetic Nephropathy. Submitted to Wright State University.

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