Shashi Kumar R
CRA at TCRS🏢 | Site Management & Study Startup Expert | Driving Regulatory Compliance & Efficient Site Activation | Distance Runner Focused on Discipline & Endurance 🏃♂️
- Role
- Clinical Research Associate at Trialcraft Clinical Research Services Pvt. Ltd
- Location
- Salem, IN
- LinkedIn followers
- 500 followers
About Shashi Kumar R
As a Clinical Research Associate with 1+ year of experience in a startup CRO and Site management Organization, I’ve been actively involved in Clinical Operations, Site Management, and Regulatory Compliance. Starting from zero projects, I leveraged strategic networking with sponsors, investigators, and stakeholders to bring in successful clinical trials to our CRO and SMO. My key contributions include: 1. Site Feasibility & Selection 2. Study Startup & Site Activation 3. Regulatory Documentation (EC/IRB) 4. Site Monitoring & SDV 5. Sponsor & Site Communication I’m passionate about quality, ethics, and accelerating research outcomes through strong site relationships and operational excellence.
Experience
Clinical Research Associate
Trialcraft Clinical Research Services Pvt. Ltd
Jul 2024 — Present · Kanchipuram, IN
Regulatory Knowledge & ComplianceUnderstanding ICH-GCP, FDA, and EMA guidelines.Staying updated with evolving regulations.2. Site Management & MonitoringConducting site selection, initiation, and close-out visits.Ensuring trial sites follow protocols and compliance standards.3. Data Integrity & Source VerificationEnsuring accuracy of Case Report Forms (CRFs) and patient data.Identifying discrepancies and resolving them efficiently.4. Communication & Stakeholder ManagementCoordinating with investigators, sponsors, and regulatory bodies.Effective written and verbal communication for documentation and reporting.5. Risk Management & Problem-SolvingIdentifying potential trial risks and implementing corrective actions.Resolving site issues and ensuring trial continuity.6. Time Management & Multi-TaskingHandling multiple clinical sites and deadlines simultaneously.Prioritizing site visits, data verification, and reporting.7. Technology & EDC (Electronic Data Capture) SystemsProficiency in platforms like Medidata Rave, Oracle Clinical, and Veeva Vault.Adopting digital tools for remote monitoring and documentation.
Education
Nandha College of Pharmacy
M.PHARM
2022 — 2024
J.K.K. MUNIRAJAH MEDICAL RESEARCH FOUNDATION, ANNAI J.K.K. SAMPOORANI AMMAL COLLEGE OF PHARMACY (Inst. Code - 082), ETHIRUMEDU
B.pharm
2017 — 2022
Malco Vidyalaya Matric Higher Secondary School
HSC or +2 - Bio Maths
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