SOWJANYA POLUMATLA
Columbus
Summary
Clinical Research Professional with a PharmD and MS in Pharmacology & Toxicology and 4+ years of experience leading and supporting clinical trials across site and CRO environments. Experienced in protocol review, regulatory compliance, audit readiness, and cross-functional team coordination. Proven ability to manage study operations, improve data quality, and ensure timely delivery of clinical research milestones. Strong focus on patient-centered care and regulatory excellence.
Demonstrates strong analytical, communication, and teamwork skills, with proven ability to quickly adapt to new environments. Eager to contribute to team success and further develop professional skills. Brings positive attitude and commitment to continuous learning and growth.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator
Centricity Research
Columbus, OH
03.2025 - Current
- Oversee day-to-day clinical trial operations, ensuring alignment with protocols, SOPs, and regulatory requirements.
- Review and analyze study protocols to support accurate implementation and data collection processes.
- Coordinate with cross-functional teams (investigators, sponsors, CROs, and regulatory staff) to ensure efficient trial execution.
- Identify protocol deviations and implement corrective actions, improving audit readiness and data quality by ~20%.
- Support budget tracking, contract documentation, and timely submission of study deliverables.
- Act as liaison between research staff, principal investigators, and sponsors to maintain clear communication.
- Assist in training and mentoring new staff and research assistants on study procedures and compliance standards.
- Manage patient recruitment, informed consent, and visit coordination while ensuring patient safety and experience.
- Ensure proper handling, processing, and shipment of specimens in compliance with IATA/DOT regulations.
Clinical Research Coordinator & Clinical Rater
American Clinical Research Institute
Dayton, OH
01.2024 - 03.2025
- Managed multiple site clinical trials, ensuring compliance with FDA, ICH-GCP, and institutional policies.
- Led regulatory processes including IRB submissions, safety reporting, and maintenance of regulatory binders.
- Coordinated study start-up, activation, and monitoring visits with sponsors and CROs.
- Contributed to process improvements and SOP adherence to enhance operational efficiency.
- Supported audit readiness and participated in internal and external audits.
- Tracked study timelines and deliverables to ensure on-time completion of milestones.
- Served as a primary point of contact for investigators and study teams.
Clinical Research Intern
Wright State Physicians
Fairborn, OH
09.2024 - 12.2024
- Assisted in regulatory compliance activities, including IRB submissions and adverse event reporting.
- Maintained study documentation and supported audit preparation efforts.
- Coordinated patient visits and supported recruitment activities.
RIMS, Regulatory Data Management & QC Specialist
IQVIA
08.2022 - 08.2023
- Supported global regulatory submissions and ensured compliance with FDA and EMA requirements.
- Maintained regulatory systems and contributed to audit readiness and data validation processes.
- Collaborated with cross-functional teams to ensure timely and accurate submission deliverables.
Junior Regulatory Associate
Frey Software Services
05.2020 - 08.2022
- Managed product lifecycle submissions and regulatory documentation across global markets.
- Ensured compliance with international regulatory standards and supported data migration initiatives.
Research Coordinator
Pragathi Hospital
06.2018 - 06.2020
- Led coordination of a clinical study on PCOS treatment, including protocol implementation and patient management.
- Managed recruitment, data collection, and regulatory documentation.
- Ensured adherence to study timelines and compliance requirements.
Education
MS - Pharmacology & Toxicology (Clinical Trial Certification)
Wright State University
Fairborn, OHDoctor of Pharmacy (PharmD) - undefined
Andhra University
IndiaSkills
- Veeva Vault
- Medidata Rave
- Redcap
- CTMS
- EHR Systems
- Good clinical practices
- Electronic data capture
- Documentation management
- Adverse event reporting
- Research sops understanding
Certification
- Good Clinical Practice (ICH-GCP)
- Clinical Trials Certification
- IATA & HIPAA Certification
CORE COMPETENCIES
- Clinical Trial Management & Oversight
- Protocol Development & Review
- Regulatory Compliance (FDA, ICH-GCP, IRB, TJC)
- Budget & Contract Support
- Cross-functional Team Leadership
- Data Management & Quality Assurance
- SOP Development & Process Improvement
- Audit & Inspection Readiness
- Staff Training & Mentorship
- Patient Recruitment & Retention
LEADERSHIP & COMPLIANCE EXPERIENCE
- Participated in leadership discussions and process improvement initiatives.
- Contributed to SOP development and implementation.
- Ensured compliance with regulatory standards and audit requirements.
- Supported staff training and performance feedback.
- Maintained strong understanding of patient- and family-centered care principles.
Timeline
Clinical Research Coordinator
Centricity Research
03.2025 - Current
Clinical Research Intern
Wright State Physicians
09.2024 - 12.2024
Clinical Research Coordinator & Clinical Rater
American Clinical Research Institute
01.2024 - 03.2025
RIMS, Regulatory Data Management & QC Specialist
IQVIA
08.2022 - 08.2023
Junior Regulatory Associate
Frey Software Services
05.2020 - 08.2022
Research Coordinator
Pragathi Hospital
06.2018 - 06.2020
Doctor of Pharmacy (PharmD) - undefined
Andhra University
MS - Pharmacology & Toxicology (Clinical Trial Certification)
Wright State University