Venkata Puli

Clinical Research Coordinator with 4+ years of experience coordinating Phase II-III oncology and cardiology clinical trials across India and the United States. Expertise in study start-up, participant recruitment, informed consent, regulatory compliance, EDC data management, AE/SAE reporting, investigational product accountability, and sponsor monitoring visits, ensuring compliance with FDA, ICH-GCP, HIPAA, 21 CFR Part 11, CDSCO, and IRB/IEC requirements. Proficient in Epic EMR, Medidata Rave, Veeva eTMF, Veeva CTMS, Florence eBinders, and Microsoft Office Suite, with a proven ability to collaborate with Principal Investigators, sponsors, Clinical Research Associates (CRAs), and cross-functional teams to deliver high-quality clinical trials, maintain audit readiness, and achieve study milestones.

Clinical Research Coordinator - Helios Clinical Research - TX, USA

(2025-08)

• Coordinated 6-8 Phase II-III oncology and cardiology clinical trials, leading study start-up activities including Site Qualification Visits (SQVs), Site Initiation Visits (SIVs), IRB submissions, protocol amendments, and site activation while ensuring compliance with FDA, ICH-GCP, HIPAA, and 21 CFR Part 11 requirements.
• Screened 250+ potential participants, enrolled 120+ eligible subjects, managed eConsent, randomization, and visit-window compliance, achieving >95% participant retention through proactive patient education and follow-up.
• Managed Essential Regulatory Documents, FDA Form 1572, Investigator Brochure updates, Delegation of Authority logs, Financial Disclosure Forms, continuing reviews, and study close-out documentation using Veeva eTMF, Florence eBinders, and Veeva CTMS.
• Performed Source Document Review, Source Data Verification (SDV), EDC data entry, medical record review in Epic EMR, and query management using Medidata Rave, supporting database lock activities while maintaining high data accuracy and ALCOA+ compliance.
• Reported AEs, SAEs, SUSARs, protocol deviations, and unanticipated problems to investigators, sponsors, and the IRB within regulatory timelines, supporting audit readiness, FDA inspection readiness, CAPA implementation, and remote monitoring activities.
• Coordinated IWRS/IRT, investigational product accountability, pharmacy reconciliation, central laboratory vendor management, specimen tracking, temperature monitoring, and laboratory sample reconciliation throughout the study lifecycle.
• Collaborated with Principal Investigators, Clinical Research Associates (CRAs), sponsors, pharmacists, central laboratories, and multidisciplinary clinical teams to support feasibility assessments, recruitment strategies, monitoring follow-up actions, and timely study execution across multiple protocols.
• Mentored newly hired Clinical Research Coordinators and research staff on FDA regulations, ICH-GCP, Epic documentation, CTMS workflows, protocol compliance, and study-specific SOPs, improving monitoring readiness and reducing query turnaround times.

Clinical Research Coordinator - Apollo Hospital - AP, India

(2020-04 - 2023-07)

• Coordinated 8-10 concurrent Phase II-III oncology and cardiology clinical trials, supporting study start-up activities, Site Initiation Visits (SIVs), participant recruitment, informed consent, study visits, and protocol compliance in accordance with ICH-GCP, CDSCO, and Institutional Ethics Committee (IEC) requirements.
• Screened 350+ potential participants, enrolled 160+ eligible subjects, maintained screening and enrollment logs, and achieved good participant retention through effective patient education, visit scheduling, and follow-up coordination.
• Maintained Trial Master Files (TMF), Investigator Site Files (ISF), Delegation of Authority (DOA) logs, regulatory binders, essential documents, and source documentation, supporting ethics submissions, protocol amendments, continuing reviews, and study close-out activities with zero major audit findings.
• Performed EDC data entry, Source Data Verification (SDV), and query management, resolving 700+ data queries within sponsor timelines while maintaining good data accuracy and compliance with ALCOA+ data integrity principles.
• Reported Adverse Events (AEs), Serious Adverse Events (SAEs), protocol deviations, and safety documentation to investigators, sponsors, and the IEC within required timelines, while coordinating sponsor monitoring visits, follow-up actions, and CAPA implementation.
• Managed Investigational Product (IP) accountability, laboratory sample collection, processing, reconciliation, and shipment to central laboratories, ensuring complete chain-of-custody documentation and protocol adherence.
• Collaborated with investigators, pharmacists, laboratory personnel, sponsors, and Clinical Research Associates (CRAs) to ensure timely study execution, monitoring readiness, and resolution of study-related issues.
• Mentored junior Clinical Research Assistants and study coordinators on protocol-specific procedures, GCP requirements, EDC systems, study documentation, and SOP compliance, improving overall study workflow efficiency.

Clinical Research Assistant - King George Hospital - AP, India

(2019-01 - 2020-03)

• Assisted investigators with patient pre-screening, eligibility verification, informed consent documentation, and study visit coordination for oncology and cardiology clinical studies.
• Maintained regulatory binders, study essential documents, source records, and case report forms (CRFs) in accordance with ICH-GCP, institutional SOPs, and Ethics Committee requirements.
• Entered clinical data into EDC systems, reviewed source documents for accuracy, and collaborated with investigators to resolve routine data queries within study timelines.
• Coordinated collection, processing, and shipment of biological specimens to central laboratories while maintaining complete chain-of-custody documentation.
• Supported sponsor monitoring visits by preparing study documentation, tracking protocol deviations, and ensuring timely follow-up on action items.

Clinical Research Intern - Kalam Institute of Health Technology (KIHT) - AP, India

(2018-07 - 2018-12)

• Assisted research teams with data collection, literature reviews, and preparation of technical reports and research documentation for ongoing healthcare technology projects.
• Maintained research records, organized study documents, and supported regulatory and ethics documentation while ensuring compliance with institutional SOPs.
• Collaborated with multidisciplinary teams to analyze healthcare data, prepare presentations, and contribute to medical device and health technology research initiatives.

Master of Science - Health Data Science - Saint Louis University (2023-08 - 2025-08)

Bachelor of Pharmacy - Pharm.D. - Saint College of Pharmacy (2014-09 - 2018-05)