SAI KUMAR BATHULA
Denton,TX
Summary
Experienced Clinical Research Associate with expertise in clinical monitoring, regulatory compliance, and study documentation. Expertise in conducting qualification, initiation, monitoring, and closeout visits to ensure adherence to protocols, Good Clinical Practice (GCP), and regulatory requirements. Skilled in site selection, investigator evaluations, and regulatory submissions, ensuring compliance with FDA, ISO 14155, and GCP guidelines for medical devices and in vitro diagnostics (IVDs). Proficient in documentation verification, case report form review, and investigational product inventory management, identifying and resolving discrepancies, adverse events, and protocol deviations, maintaining high-quality data integrity. Experienced in protocol development, clinical documentation, and study team collaboration. Skilled in utilizing Microsoft Office Suite for documentation, reporting, and communication.
Overview
1
1
year of professional experience
1
1
Certification
Work History
Clinical Research Associate
IQVIA
Bangalore, Karnataka, India
06.2022 - 06.2023
- Conducted clinical monitoring visits, including qualification, initiation, monitoring, and closeout visits at research sites to ensure compliance with the approved protocol, GCP, and SOPs
- Participated in site selection, evaluate investigator qualifications, facilities, laboratories, and equipment, and supported site contracts
- Assisted in regulatory submissions, maintained regulatory documentation & records, supported audits/inspections, ensured trials comply with FDA, GCP, and ISO 14155 regulations for medical devices and IVDs
- Conducted documentation verification and case report form review, performed QA verification to identify, resolve discrepancies, missing data, and verified investigational product inventory management
- Ensured accurate data reporting, reviewing of study records, and documentation of adverse events, protocol deviations, and findings, communicated protocol deviations and assay data inconsistencies, addressing issues
- Contributed to protocol development, writing clinical protocols, and designing case report forms, study aids, and database development, ensured adherence to good documentation practices and proper study conduct
- Provided feedback to research sites, ensuring adherence to SOPs, GCP, and regulatory documentation requirements
- Addressed issues related to investigational products and ensure proper site adherence to study protocols
- Performed closeout visits, verified study documentation, finalized data reporting, and ensured documentation verification for regulatory submissions, supported study teams in preparing final reports and assisting with regulatory inspections
- Utilized Microsoft Office Suite (Word, Excel, Outlook) for study documentation, reporting, and communication, ensured documentation management and compliance with all clinical research activitiesReviewed and monitored clinical trial sites to ensure compliance with Good Clinical Practices guidelines.
- Maintained accurate records of all regulatory submissions, correspondence and approvals received from local ethics committees or regulatory agencies.
- Tracked enrollment status across multiple sites to ensure target goals were met in a timely manner.
- Coordinated the submission of regulatory documents to IRBs and ECs and other relevant authorities.
- Analyzed collected data for accuracy prior to database lock; identified discrepancies when necessary.
- Provided support in writing informed consent forms, patient diaries, study manuals.
- Developed and managed budgets for clinical trials according to study protocols.
- Reviewed and monitored clinical trial sites to ensure compliance with Good Clinical Practices guidelines.
- Participated in internal audits related to clinical research operations processes.
- Performed clinical research activities including protocol development, subject recruitment and data collection.
- Established and updated site monitoring schedule and served as project head for investigational sites.
Education
Master of Science - Healthinformatics
University of North Texas
Denton, TX12-2024
Bachelors - Pharmacy
Acharya Nagarjuna University College of Pharmaceutical Sciences
Guntur, Andhra Pradesh,India05-2022
Certification
- Introduction to Clinical Data from Stanford University
- Introduction to Healthcare from Stanford University
- AI in Healthcare Capstone from Stanford University
- Certified Good Clinical Practice Professional (CGCPP)
- Certified Medical Monitor (CMM)
Languages
English
Professional
Telugu
Full Professional
Hindi
Professional
Timeline
Clinical Research Associate
IQVIA
06.2022 - 06.2023
- Introduction to Clinical Data from Stanford University
- Introduction to Healthcare from Stanford University
- AI in Healthcare Capstone from Stanford University
- Certified Good Clinical Practice Professional (CGCPP)
- Certified Medical Monitor (CMM)
Master of Science - Healthinformatics
University of North Texas
Bachelors - Pharmacy
Acharya Nagarjuna University College of Pharmaceutical Sciences
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