Your Name
Clinical Research Associate · ICH-GCP, Site Monitoring, EDC, CTMS
your.email@example.com | +91 XXXXX XXXXX | Bengaluru, India | linkedin.com/in/your-profile
Summary
Clinical research associate with 3 years across site coordination and monitoring for Phase II–III oncology and diabetes trials. Has monitored 6 sites and 400+ subjects under ICH-GCP and the NDCT Rules 2019, with strong SDV, EDC query and SAE reporting habits.
Experience
- Led 45 monitoring visits across 6 oncology sites in a Phase III trial, completing 100% planned source data verification and closing 210 action items within 30 days.
- Monitored SAE reporting at 6 sites against NDCT Rules 2019 timelines, ensuring all 23 SAEs reached CDSCO and ethics committees within 14 days with zero late reports.
- Reduced open EDC queries from 380 to 60 in 8 weeks by training site coordinators on CRF completion guidelines and running weekly query-review calls.
- Delivered site initiation visits at 3 new sites, training 20 investigators and coordinators on the protocol, informed consent process and CTMS entries before first patient in.
- Managed informed consent for 120 subjects across 2 diabetes trials, using a version checklist that kept consent deviations at zero through 2 sponsor audits.
- Cut EDC data-entry lag from 10 days to 2 by entering each visit's CRFs within 48 hours, lifting the site to 2nd of 18 in sponsor data-quality rankings.
- Maintained the investigator site file and ethics committee submissions for 3 protocols, closing all 15 sponsor audit findings within 21 days.
Projects
- Analyzed 220 ADR reports from a 600-bed hospital using WHO-UMC and Naranjo causality scales, finding that 34% were linked to antibiotics.
- Designed a 1-page ADR reporting form for ward nurses, raising monthly ADR reports from 12 to 30 during the 4-month study.
Skills
Clinical Operations: Clinical Research, Site Monitoring, Source Data Verification (SDV), Site Initiation Visit, Informed Consent, Protocol Deviations, TMF
Safety & Regulations: ICH-GCP, SAE Reporting, NDCT Rules 2019, CDSCO, Ethics Committee Submissions
Systems: EDC (Medidata Rave), CTMS, CRF Review, eTMF, MS Excel
Therapy Areas: Oncology, Diabetes, Phase II–III Trials
Education
Certifications
- ICH-GCP Certification – NIDA Clinical Trials Network
- Clinical Research course – ICRI