Summary
Overview
Work History
Education
Skills
Technical Proficiencies
Research
Timeline
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Karthik Thotakuri

Wentzville,MO

Summary

Qualified Clinical Research Associate with experience in human subjects research, microbiological lab procedures, and clinical trial monitoring. Strong background in drug safety, pharmacology, and pharmacovigilance, together with practical expertise in site monitoring, multi-site clinical study coordination, and regulatory compliance (FDA, EMA). Competent in data management systems (CTMS, EDC, and Argus Safety), ICH guidelines, and Good Clinical Practice (GCP). Competent in offering logistical, technical, and regulatory support for clinical study locations, guaranteeing smooth trial execution in accordance with industry standards and guidelines.

Overview

5
5
years of professional experience

Work History

Clinical Research Associate

Pro Relix Research
08.2023 - Current
  • Conducted remote and on-site clinical trial monitoring, guaranteeing adherence to regulatory requirements and study procedures (ICH-GCP, FDA, EMA)
  • Verified that patient safety was maintained and that study site operations followed Good Clinical Practices (GCP)
  • Complied with FDA, EMA, and ICH-GCP regulations by making sure all study documentation was correct and current
  • Assisted the preparation of reports and regulatory submissions for institutional review boards (IRBs) and ethics committees
  • Monitored adverse drug reactions (ADRs) and made sure that pharmacovigilance rules were followed when reporting AE/SAE occurrences
  • Worked along with investigators to evaluate the seriousness and cause of adverse events
  • Served as a point of contact for study sponsors, researchers, and site staff to guarantee a smooth trial
  • Worked closely with the Data Management team to resolve data discrepancies, ensuring accuracy in Electronic Data Capture (EDC) systems (REDCap, Inform)
  • Conducted source document verification (SDV) to ensure data integrity and consistency across clinical sites
  • Arranged for the study specimens' transportation and receipt, guaranteeing that biological samples were handled correctly
  • Oversaw site inventory to guarantee that research supplies and investigative goods were available for continuous trial advancement
  • To guarantee protocol adherence, I helped with Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), and Close-Out Visits (COVs)
  • Examined Case Report Forms (CRFs) to make sure they were accurate and comprehensive

Intern

Malla Reddy Health City
Hyderabad, India
09.2020 - 09.2021
  • Provided medication counseling to patients, ensuring proper medication use and safety
  • Reviewed and evaluated medication orders for accuracy and appropriateness
  • Assisted healthcare teams with drug-related information and dosage recommendations
  • Monitored adverse drug events and provided recommendations for treatment adjustments
  • Participated in clinical consultations, providing insights into therapeutic drug monitoring

Education

Masters in Medical Informatics - Health Data Science

Saint Louis University
Saint Louis, MO
05.2023

Doctor of Pharmacy - Microbiology, Infectious Diseases, Clinical Pharmacology, Biostatistics

Osmania University
Hyderabad, India
09.2021

Skills

  • Clinical Trial Monitoring & Site Management
  • Human Subjects Research & Ethical
  • Pathogen identification
  • Sample Processing
  • Culture Preparation
  • Adverse Event (AE) & Serious Adverse Event (SAE) Reporting
  • Good Clinical Practice (GCP) & ICH Guidelines
  • Regulatory Compliance (FDA, EMA)
  • Data Collection & Documentation
  • Cross-functional Team Collaboration
  • Pharmacology Expertise & Drug Interactions
  • Research & Statistical Analysis (R Programming)
  • Clinical Trial Management Systems (CTMS): Medidata, Oracle Clinical
  • Electronic Data Capture (EDC) Systems: REDCap, Inform
  • Safety Databases: Argus Safety, Veeva Vault Safety
  • Statistical Analysis: R Programming
  • Microsoft Office Suite (Word, Excel, PowerPoint)

Technical Proficiencies

Medidata, Oracle Clinical, REDCap, Inform, Argus Safety, Veeva Vault Safety, R Programming, Word, Excel, PowerPoint

Research

  • Conducted human-subject research following ethical guidelines (CITI-certified) to assess pain management efficacy in adults with lumbar radiculopathy.
  • Created a thorough research procedure, gathered and examined data using statistical software (R), and reported results on the effectiveness of pain treatment, side effects, and drug adherence.
  • Observed microbiological lab operations to make sure they adhered to legal and research standards.
  • Arranged site supplies and inventories to guarantee smooth study execution and avoid interruptions.
  • Verifying informed consent procedures and upholding ethical norms helped with research involving human beings.
  • Oversaw correspondence with research locations, working with Data Management and Clinical Scientists to resolve data inconsistencies.

Timeline

Clinical Research Associate

Pro Relix Research
08.2023 - Current

Intern

Malla Reddy Health City
09.2020 - 09.2021

Masters in Medical Informatics - Health Data Science

Saint Louis University

Doctor of Pharmacy - Microbiology, Infectious Diseases, Clinical Pharmacology, Biostatistics

Osmania University

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Karthik Thotakuri