Vishnu G
Professional Summary
Clinical Research Associate with 5+ years of experience conducting site management and monitoring across Phase I–IV programs in gene therapy, ophthalmology, medical devices, cardiology, endocrinology and psychiatry. Proven operator across SQV, SIV, IMV and COV visits using risk-based monitoring to prioritize SDV/SDR and reduce repeat findings. Hands-on with Veeva Vault, Medidata Rave, REDCap, RealTime CTMS and Trial Interactive for eTMF/EDC/CTMS workflows; builds operational dashboards in Tableau, Power BI and Advanced Excel and performs statistical review in SAS/SPSS. Experienced running site start-up to close-out, IRB and ClinicalTrials.gov management, IRT/IVR coordination, and TMF inspection readiness under ICH-GCP, FDA 21 CFR Part 11, HIPAA and GDPR. Seeking CRA I/II or regional CRA (C2C) roles supporting sponsor or CRO site oversight and central monitoring.
Technical Skills
Work Experience
- Conducted SQV, SIV, IMV and COV monitoring visits under RBM principles to prioritize high-risk source verification activities at gene therapy and ophthalmology sites.
- Performed SDV/SDR and discrepancy escalation against source documentation in Veeva Vault, initiating and driving CAPA through to documented closure.
- Managed eTMF lifecycle in Trial Interactive to maintain ALCOA+ inspection readiness for sponsor and regulatory audits.
- Coordinated IRT/IVR activities and investigational product accountability checks to verify chain-of-custody and storage conditions for viral-vector shipments.
- Trained site coordinators on Veeva Vault EDC workflows and source documentation standards, reducing repeat findings across subsequent monitoring visits.
- Tracked start-up milestones, enrollment KPIs and issue logs in RealTime CTMS and escalated at-risk sites to sponsors for timeline mitigation.
- Led start-up, site activation and SIV/IMV/COV readiness for 10 concurrent Phase I–IV ophthalmology trials, managing feasibility and IRB submission workflows.
- Managed TMF/eTMF documentation in Veeva Vault and Trial Interactive to uphold ALCOA+ standards and sponsor inspection readiness.
- Monitored enrollment and visit-window compliance using RealTime CTMS and Medidata Rave to identify and mitigate operational risks.
- Prepared IRB/EC submission packages and maintained ClinicalTrials.gov entries to meet sponsor and regulatory timelines.
- Built source documentation and regulatory binders for monitor review that passed sponsor SIVs with zero critical findings.
- Coached site staff on Medidata Rave and REDCap EDC workflows to standardize data entry and accelerate query resolution.
- Authored study-specific Data Management Plans, SOPs and work instructions aligned to ICH-GCP E6(R2/R3) and FDA 21 CFR Part 11.
- Led CRF design and managed Medidata Rave database build, validation and edit-check development through to database lock.
- Directed query management and coordinated data-cleaning activities across sites to deliver on-time database locks for device studies.
- Mentored site coordinators and data specialists on eCRF completion and deviation-prevention techniques to improve data quality.
- Coordinated sponsor and IRB readiness activities to support pre-enrollment compliance reviews.
- Developed Tableau dashboards to visualize data-cleaning metrics, enrollment trends and lock readiness for study teams.
- Led site operations for two concurrent Phase II/III trials including an AI-enabled coronary atherosclerosis imaging study and a wound graft device study.
- Served as Lead CRC on the COMS One pivotal Phase III device trial, supervising 150+ enrolled subjects and overseeing protocol implementation.
- Ensured zero unblinding incidents through strict blinded-assessment controls and source documentation oversight.
- Integrated Dexcom CGM datasets, HbA1c trends and adherence metrics into study databases and performed outcome analyses using SPSS and SAS.
- Built Excel and Tableau dashboards to monitor enrollment, retention and dropout trends, informing targeted outreach that improved retention by 22%.
- Implemented AE/SAE tracking and streamlined regulatory reporting workflows to accelerate sponsor notification timelines.
Education
Certifications
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