Samir Salunkhe
Clinical Research Coordinator @Poona Hospital And Research Centre
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WORK HISTORY
Clinical Research Coordinator @Poona Hospital And Research Centre
Coordinated end-to-end clinical trial activities from study start-up to close-out • Conducted site feasibility assessments and supported site selection • Prepared and submitted regulatory documents to IRB/EC • Coordinated Site Initiation Visits (SIV), monitoring visits, and investigator meetings • Managed patient recruitment, screening, and informed consent process (ICF) • Ensured protocol adherence for subject enrollment and eligibility • Tracked study visits, follow-ups, and patient compliance • Reported and documented Adverse Events (AE/SAE) • Ensured accurate EDC data entry, query resolution, and data quality • Maintained ISF and essential documents in compliance with ICH-GCP
EDUCATION
Savitribai Phule Pune University
Bachelor of Pharmacy, Pharmacy
Arete Training Institute
Post graduation diploma in Clinical Research, Clinical Research Coordinator
ABOUT SAMIR SALUNKHE
Senior Clinical Research Coordinator
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