Clinical Trial Regulatory Compliance

Raviteja Alwala Clinical Trial Coordinator

+*(***)– 539– 6002 Illinois, Chicago ****************@*****.*** LinkedIn PROFESSIONAL SUMMARY

Clinical Trial Coordinator with 3+ years of experience managing site operations, subject recruitment, and protocol adherence, optimizing clinical workflows to enhance patient retention by 35% and streamline multi-site trial execution.

Expert in regulatory compliance and clinical documentation, ensuring strict adherence to ICH-GCP, FDA, HIPAA, and IRB protocols, implementing risk-based monitoring and audit readiness strategies, resulting in 100% regulatory compliance and zero deviations.

Proficient in clinical data management and trial monitoring, utilizing EHR/EMR systems, electronic data capture (EDC), and REDCap, integrating SQL and Power BI to automate data reporting, reducing manual errors by 40% and improving real-time decision-making.

Skilled in cross-functional coordination and patient safety, collaborating with investigators, sponsors, CROs, and ethics committees, ensuring adverse event reporting, pharmacovigilance, and informed consent compliance, maintaining 99.5% data accuracy. TECHNICAL SKILLS

Clinical Research & Compliance: ICH-GCP, FDA Regulations, IRB Submissions, Protocol Development, HIPAA Compliance, Ethics & Informed Consent

Electronic Health Records & Data Management: EHR, EMR, Electronic Data Capture (EDC), Case Report Forms (CRFs), Clinical Trial Management Systems (CTMS), Pharmacovigilance, Adverse Event (AE) Reporting Regulatory & Quality Assurance: Regulatory Submissions, Risk-Based Monitoring, Good Documentation Practices (GDP), Quality Control

(QC), Audit Readiness, CAPA (Corrective and Preventive Actions) Clinical Trial Operations: Patient Recruitment & Retention, Site Initiation & Monitoring, Investigator & Sponsor Coordination, Protocol Adherence, Vendor & CRO Management

Healthcare Data & Analytics: SPSS, SAS, R, SQL, Tableau, Power BI, Biostatistics, Epidemiology, Real-World Evidence (RWE), Data Standardization (CDISC, SDTM, ADaM)

Medical & Scientific Knowledge: Clinical Trial Phases (I-IV), Drug Development Process, Pharmacovigilance, Disease Pathology, Safety & Risk Management, Evidence-Based Medicine

Technology & Automation: Medidata, Veeva

PROFESSIONAL EXPERIENCE

Clinical Trial Coordinator, CVS Health Jan2025 – Present Illinois, Chicago

Directed Phase I–IV clinical trials, including studies in hypertension, ensuring strict adherence to FDA, ICH-GCP, and IRB regulations. Oversaw protocol development, regulatory submissions, and site compliance—resulting in a 40% reduction in audit findings through process improvement initiatives.

Managed participant enrollment, eligibility screening, and informed consent for over 150 patients, including those with chronic cardiovascular conditions. Utilized EDC platforms (Medidata, REDCap) and CTMS to streamline workflows and reduce data discrepancies by 25%.

Prepared site documentation and led IRB submissions and protocol deviation reporting for hypertension studies, ensuring timely approvals and full regulatory compliance. Collaborated with PIs on AE/SAE reporting, improving documentation efficiency by 35%.

Maintained drug accountability logs, performed CRF review, and ensured data integrity through rigorous source documentation. Used eTMF for real-time regulatory tracking, reducing hypertension trial deviations by 20%.

Partnered with cross-functional teams including cardiologists, monitors, and biostatisticians to enhance protocol execution and data accuracy in blood pressure monitoring studies. Improved study timelines by 30% through workflow automation.

Conducted site initiation, monitoring, and study close-out visits per GCP, FDA, and sponsor SOPs. Developed and delivered protocol-specific training workshops for site staff focused on hypertension study endpoints and regulatory expectations, boosting team competency by 35%.

Demonstrated strong organizational skills and attention to detail while managing multi-site data entry and trial documentation.

Assisted in preparing and updating study documentation, including informed consent forms (ICFs) and case report forms

(CRFs).

Coordinated study meetings, prepared agendas, and ensured effective team communication and documentation.

Tracked and managed study supplies and site materials, contributing to inventory management efficiency. Clinical Trial Coordinator, Apollo Hospitals Aug 2020 – Jul2023 Hyderabad, Telangana

Coordinated site operations for both oncology (1 year) and COVID-19 vaccine trials (2 years), from study start-up to closeout, ensuring CDSCO, ICH-GCP, and ethics committee compliance, reducing regulatory delays by 20%.

Managed participant screening, informed consent, and enrollment across 10+ multi-site trials, including Phase II/III oncology studies and vaccine protocols. Used EPIC and CTMS to streamline workflows, reducing discrepancies by 30%.

Oversaw IRB submissions for oncology and COVID studies, ensuring timely approval of protocols, amendments, and deviations. Developed streamlined site documentation workflows, improving audit readiness.

Conducted safety monitoring, AE/SAE tracking and reporting, with a focus on oncology and immunization trials. Achieved 95% SAE report approval and supported global pharmacovigilance compliance.

Used EDC platforms (Medrio, OpenClinica) to standardize data capture. Reduced missing data by 28% through automated error detection and real-time validation for high-risk oncology patients.

Collaborated with oncologists, infectious disease experts, regulatory teams, and sponsors, improving interdisciplinary coordination and patient retention by 15% using tailored engagement strategies.

Led GCP training and AE documentation workshops for research teams, focused on oncology protocols and vaccine safety. Ensured 98% compliance across trial sites and implemented protocol-specific SOPs.

Implemented QA procedures through internal audits and compliance checks. Standardized AE/SAE workflows and strengthened oncology-specific documentation, ensuring 100% regulatory adherence.

Trained staff across departments on GCP, EDC systems, protocol deviations, and data quality. Improved documentation accuracy by 28% and maintained robust oncology and vaccine trial data integrity. EDUCATION

Governors State University Illinois., Chicago

Master of Science in Health Informatics

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