Biznet ,Oracle ,Medidata, REDcap, Veeva Vault CTMS
Saurabh Chandra
CRC, Site Manager, Lab Technician, Pharmacist, Phlebotomist
Varanasi,UP
Summary
Clinical Research Associate supporting site monitoring, SDV, and source document review across 1–3 active sites at a time in Phase 1–4 trials. Tracks SAE reporting, CAPA follow-up, and monitoring visit documentation and completes 5–8 monitoring visits per month to keep sites inspection-ready and aligned with GCP expectations. Brings therapeutic exposure across oncology, gastro, neuro, endocrinology, and anti-infective studies.
Overview
3
3
Languages
10
10
Certifications
6
6
years of professional experience
Work History
CRC
Banaras Hindu University
03.2019 - 03.2025
- Clinical Trial Management Coordinating Phase 1 to 4 study
- Patient Recruitment & Screening
- Patient Handling, SAE reporting and AE Record
- SDV, SIV, and Monitoring
- ICF Narration and consenting, CRF Entry, Feasibility
- Subject Screening, Randomization, EC Approval, EC Notification
- ISF& Essential Document Maintenance
- Study Approval, Close out, Invoice making
- CTMS, Lab Investigation Report Enters to EDC
- Data management oracle, Biznet Software
- Therapeutic Area Experience- Oncology, Gastro, Neuro, endocrinology, Anti infective& Anti-viral
- 2025-2026 Career Break
- Worked effectively in fast-paced environments.
- Skilled at working independently and collaboratively in a team environment.
- Proven ability to learn quickly and adapt to new situations.
- Self-motivated, with a strong sense of personal responsibility.
- Passionate about learning and committed to continual improvement.
Education
DIPLOMA IN PHARMACY - Pharmaceutical Medicine
UTTAR PRADESH TECHNICAL EDUCATION
LUCKNOW 04.2001 -
Diploma in Medical Laboratory Science - Pathology Microbiology Biochemistry Blood Banking
ALL INDIA MEDICAL LAB TECHNOLOGY ASSOCIATION
Nilayam Paramedical Institute Sunderpur Varanasi 04.2001 -
Master of Science - Clinical Research
Indian Clinical Research Institute With Lingyas University
New Delhi, India 04.2001 -
Bachelor in Education - Teaching Aptitude
MGKVP Varanasi U.P
Varanasi, U.P01-2015
Graduation - Bachelor in Science
VBS Purvanchal University Jaunpur U.P
Jaunpur, U.P01-2012
Higher Secondary Certificate (Class 12 - Science) - undefined
K. D Inter College U.P State Board
01-2009
Skills
Feasibility ,CDA, SQV, SIV,SDV
ICF Consenting,TMF Binder
Trial startup document,Trial Conduct Document,Trial close out Documents
GCP, SAE AE Reporting ,SUSAR, EDC
IP Accountability, Verify Drug MonitorStorage Condition, Ensure storage condition
Generate Follow up letter,Prepare Monitoring visit Report,Archieve Study Related Document
AI, Chatgpt, Gemini ,Microsoft word ,Excel Powerpoint Proficiency
Safety monitoring
AE reporting
Concomitant medication review
IP accountability
CAPA management
ICH GCP compliance
Pharmacovigilance database management
Protocol deviation management
Trip report writing
TMF oversight
Regulatory submission support
Inspection readiness
Clinical trial budgeting
Query management
Accomplishments
- Supervised team of 15 staff members
- Used Microsoft Excel to develop Inventory tracking Spreadsheets
- Achieved Result by completing task recruit subject within 60 days accuracy and efficiency
Software
Certification
GCP GUIDELINES
Hobbies
Playing Indoor& outdoor Games Cricket,Football,Riding , Listening Songs& Movies ,Reading ,Explore New places, Debate on Political Matter
Timeline
CRC
Banaras Hindu University
03.2019 - 03.2025
DIPLOMA IN PHARMACY - Pharmaceutical Medicine
UTTAR PRADESH TECHNICAL EDUCATION
04.2001 -
Diploma in Medical Laboratory Science - Pathology Microbiology Biochemistry Blood Banking
ALL INDIA MEDICAL LAB TECHNOLOGY ASSOCIATION
04.2001 -
Master of Science - Clinical Research
Indian Clinical Research Institute With Lingyas University
04.2001 -
Higher Secondary Certificate (Class 12 - Science) - undefined
K. D Inter College U.P State Board
Graduation - Bachelor in Science
VBS Purvanchal University Jaunpur U.P
Bachelor in Education - Teaching Aptitude
MGKVP Varanasi U.P