Sharath K N

I’m a Clinical Research Coordinator who thrives on detail and patient-focused execution, with a proven track record of delivering trials in strict alignment with ICH-GCP and regulatory requirements. In my current role at CLINISYD Research Global Solutions Pvt Ltd, I support site performance as a Site Manager/Clinical Research Coordinator and also cover feasibility coordination.

I’ve worked across Phase II and Phase III studies, including clinical programs in glomerular kidney disease with proteinuria, untreated metastatic non-squamous non-small cell lung cancer, and GLP1 receptor agonist therapy for Type 2 Diabetes. I bring a strong compliance mindset while staying focused on quality outcomes for every participant and every protocol requirement.

Previously, at Hastin Research Inc (Victoria Hospital, Bangalore Medical College and Research Institute), I coordinated registry and interventional work, including the BIRAC (Biotechnology Industry Research Assistance) Hospital-based Multicentric Diabetes Registry where I consented over 4000 subjects for future clinical trials. I also screened over 110 newly diagnosed diabetic patients for precision medicine for anti-diabetic therapy, while handling key study startup, regulatory submissions, budget negotiation support, and recruitment and retention activities.

From end-to-end trial operations to data accuracy, I ensure data integrity and study quality by managing day-to-day clinical trial activities, maintaining Investigator Site Files, scheduling subject visits, performing randomization and IWRS-linked dispensing, and updating source records and CRFs. I complete electronic case report forms using Veeva Vault and iMedidata, report adverse events/SAEs with the Investigator, and facilitate close-out with the CRA—while mentoring new team members to build a culture of continuous learning.