Summary
Overview
Work History
Education
Skills
Websites
Certification
Timeline
Generic

SRI GAYATHRI CHEBROLU

Augusta,GA

Summary

Regulatory Affairs and Clinical Research Specialist with 5+ years of experience providing regulatory management oversight for pre-award and post-award activities in hospital-sponsored human subjects’ research. Skilled in analyzing protocols, developing informed consent documents, preparing study amendments, and establishing and maintaining comprehensive regulatory recordkeeping systems in compliance with federal regulations on human subjects’ research, GCP, HIPAA, and institutional SOPs. Adept at liaison with trial sponsors during the regulatory submission process, responding to IRB correspondence and determination letters, and responding to requests for information from hospital departments, investigators, and outside sponsors. Proven ability to conduct feasibility assessments, obtain opinions from others when appropriate, coordinate multidisciplinary research teams, and support audit preparedness activities for site and sponsor inspections.

Overview

6
6
years of professional experience
1
1
Certification

Work History

Clinical Research & Regulatory Affairs Coordinator

Center for Podiatry Care
Augusta, GA
08.2024 - Current
  • Provide regulatory oversight functions across research sites for hospital-sponsored human subjects’ research.
  • Manage all pre-award and post-award regulatory activities, including IRB initial submissions, amendments, continuing reviews, and annual reports.
  • Analyze protocols for compliance, prepare informed consent documents, and update forms per IRB and sponsor feedback.
  • Establish and maintain comprehensive regulatory recordkeeping systems, including confidential data collection forms, proposals, and final reports.
  • Act as liaison with the trial sponsor during the regulatory submission process, collecting, organizing, logging, filing, and transmitting all required site and investigator documents.
  • Respond to IRB correspondence and determination letters and requests for information to ensure timely follow-up.
  • Conduct internal audit projects and participate in audit preparedness activities to ensure studies are conducted in accordance with federal regulations related to human subjects’ research.
  • Coordinate with multidisciplinary research teams, obtain opinions from others when appropriate, and perform feasibility assessments for new protocols.
  • Assist with monitoring visits on site and remotely, providing requested documentation and implementing corrective actions.
  • Maintain study records according to sponsor and/or regulations to ensure compliance.
  • Generate reporting metrics, enrollment logs, and compliance status reports for investigators and sponsors.

Graduate Research Assistant – Clinical Informatics

Sacred Heart University
Fairfield, CT
01.2023 - 05.2024
  • Conducted protocol reviews and developed data collection processes for clinical and epidemiological studies.
  • Ensured compliance with confidential data collection forms and hospital research policies.
  • Built reporting dashboards to track study progress and compliance.
  • Collaborated with public health and hospital teams to integrate SOP-compliant data management workflows.

Clinical Research Coordinator

Dr. Reddy’s Laboratories
Hyderabad, India
08.2020 - 01.2022
  • Managed Phase II–III clinical trials from start-up to close-out, including IRB submissions, protocol amendments, and continuing reviews.
  • Maintained regulatory binders, investigator site files, and confidential data collection forms, proposals, and final reports per SOPs and federal regulations.
  • Acted as liaison with sponsors and CROs during monitoring visits and regulatory submissions.
  • Assisted in audit preparedness and ensured ISF compliance with sponsor and regulatory requirements.

Medical Officer

Government Hospital
, India
12.2019 - 05.2020
  • Oversaw device-based clinical studies ensuring compliance with federal human subjects’ regulations and ethical matters regarding hospital-sponsored human subjects’ research.
  • Trained staff on regulatory compliance, research ethics, and SOP adherence.

Education

Master of Science - Health Informatics

Sacred Heart University
Fairfield, CT
06.2023

Bachelor of Dental Surgery (BDS) -

Dr. NTR University of Health Sciences
India
06.2021

Skills

  • Regulatory Management
  • IRB Submissions
  • Pre-/Post-Award Oversight
  • Protocol Analysis
  • Informed Consent Development
  • Study Amendments
  • AE/SAE Reporting
  • Audit Preparedness
  • Regulatory Recordkeeping
  • Compliance & Ethics
  • Federal Regulations on Human Subjects’ Research
  • Hospital-Sponsored Research
  • Confidential Data Collection Forms
  • SOP Compliance
  • IRB Correspondence
  • Ethical Matters
  • Requests for Information
  • Data Management
  • SQL
  • SAS
  • R
  • Tableau
  • Medidata
  • Medrio
  • Oracle Clinical
  • AdvancedMD EHR
  • Project & Communication Tools
  • TrackWise
  • Arena
  • RIMS
  • Mondaycom
  • Smartsheet
  • Reporting & Analysis
  • Regulatory Reporting Metrics
  • Confidential Data Logs
  • Feasibility Assessments
  • Multidisciplinary Team Coordination

Websites

Certification

  • Certified Phlebotomy Technician (CPT), NHA
  • Good Clinical Practice (GCP), NIDA Clinical Trials Network
  • Basic Life Support (BLS), AHA
  • HbA1c Analyzer Certification, Abbott
  • Tobacco Cessation Counseling, IDA CDE Program

Timeline

Clinical Research & Regulatory Affairs Coordinator

Center for Podiatry Care
08.2024 - Current

Graduate Research Assistant – Clinical Informatics

Sacred Heart University
01.2023 - 05.2024

Clinical Research Coordinator

Dr. Reddy’s Laboratories
08.2020 - 01.2022

Medical Officer

Government Hospital
12.2019 - 05.2020

Master of Science - Health Informatics

Sacred Heart University

Bachelor of Dental Surgery (BDS) -

Dr. NTR University of Health Sciences

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