Pooja Iyer
Clinical Research Associate II
pooja.iyer@example.com · +91 98XXX XXX93 · Bengaluru, Karnataka · linkedin.com/in/pooja-iyer-example
Summary
Clinical research associate with 5 years of experience, including 3 years of independent site monitoring for Phase II and III oncology and diabetes trials across South India. Experienced in ICH-GCP, New Drugs and Clinical Trials Rules 2019, site initiation to close-out, SDV and EDC query management, with consistently clean audit outcomes.
Skills
- ICH-GCP E6
- New Drugs and Clinical Trials Rules 2019
- Site monitoring (SIV, IMV, COV)
- Source data verification
- EDC query management
- CTMS and eTMF
- IP accountability
- Ethics committee submissions
Core skills
Site relationship management · Risk-based monitoring · Report writing · Audit readiness · Travel and time management
Work experience
Clinical Research Associate II, Clinova Research Services Pvt Ltd, Bengaluru
Jul 2023 – Present
- Monitor 7 sites across Karnataka, Tamil Nadu and Kerala for a global Phase III oncology trial, conducting SIVs, IMVs and COVs as per the monitoring plan.
- Complete 100% SDV for critical data points and keep open EDC queries under 15 days old, ahead of the 30-day study target.
- Helped sites raise enrolment from 1.1 to 1.8 patients per site per month through pre-screening logs and investigator follow-ups.
- Supported a sponsor audit at 2 sites with no critical findings and closed all major findings within 21 days.
Clinical Trial Coordinator, then CRA I, Medivista Clinical Trials India, Chennai
Aug 2021 – Jun 2023
- Coordinated a Phase II type 2 diabetes trial at a 600-bed hospital site, managing consent, visits, IP accountability and EDC entry.
- Prepared EC submissions and maintained the investigator site file, which scored "no findings" at the sponsor audit.
- Moved to CRA I in 2022 and co-monitored 4 sites, writing visit reports within 5 working days.
Education
M.Pharm, Pharmacology
2019 – 2021
College of Pharmacy, Chennai · 8.2 CGPA
B.Pharm, Pharmacy
2015 – 2019
College of Pharmacy, Madurai · 7.9 CGPA
Certifications
- ICH Good Clinical Practice (GCP) training, Recognised GCP training provider, Apr 2025
Languages
English (Fluent) · Tamil (Native) · Kannada (Conversational) · Hindi (Conversational)