Saikrishnareddy Singareddy
Clinical Research Coordinator (CRC II) | Phase II–III Trials | Oncology & Cardiology | ICH-GCP | AE/SAE Reporting | Medidata Rave | FDA 21 CFR Part 11
- Role
- Clinical Research Coordinator at Velocity Clinical Research, Inc.
- Location
- Manchester, NH, US
- LinkedIn followers
- 500 followers
About Saikrishnareddy Singareddy
Clinical Research Coordinator with 3+ years of experience supporting Phase multi-site clinical trials across oncology, cardiology, and pharmacovigilance. Proven track record of increasing patient enrollment by 35%, maintaining 100% on-time AE/SAE reporting, and achieving zero audit findings across 18 monitoring visits and a federal audit.Experienced in end-to-end study coordination, including patient screening and informed consent, visit scheduling, regulatory submissions, protocol deviation tracking, and investigational product management. Strong hands-on expertise with Medidata Rave, REDCap, Oracle Clinical, CTMS, eTMF/TMF, and Epic EMR, ensuring ALCOA+ compliant documentation under ICH-GCP and FDA 21 CFR Part 11 standards.Recognized for building strong relationships with patients, CRAs, PIs, sponsors, and cross-functional teams while supporting site readiness, SIVs, and protocol amendments. Passionate about patient safety, data integrity, and contributing to high-quality clinical research. Open to CRC II / Senior CRC / Research Associate opportunities in Massachusetts & New Hampshire.
Experience
Clinical Research Coordinator
Velocity Clinical Research, Inc.
Oct 2025 — Present · MO, US
Manage day-to-day operations for 6 Phase cardiology and oncology trials, collaborating with CRAs, principal investigators, and sponsors to ensure ICH-GCP compliance.Increased patient retention and reduced visit no-shows by 25% through personalized reminder workflows and patient-friendly medication education.Led site readiness activities, including 6 investigator meetings and Site Initiation Visits (SIVs), ensuring successful first-patient-in.Identified, documented, and reported 15+ AEs and 3 SAEs within FDA-mandated timelines, coordinating with medical monitors and sponsors.Oversaw temperature-controlled shipment of 500+ biological samples, maintaining full chain-of-custody and cold-chain compliance.Tracked protocol deviations in real time and supported corrective and preventive actions (CAPA) for 3 protocol amendments.Supported 18 monitoring visits and 1 federal audit with zero major findings.
Education
New England College
Master's in Health Informatics, Medical Informatics
2025
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