Manju N

About Manju N

Dynamic Visionary in Clinical Research, Fueling Progress with Passion and Purpose!…

Experience

1. Clinical Research Coordinator

   S4 Research Private Limited

   Nov 2024 — Present · Nashik, IN

   Assisted the Principal Investigator in conducting informed consent and screening procedures for over 5+ clinical studies ensuring full comprehension and compliance with participant eligibility criteria according to the study protocol.Served as a primary liaison between CRA, participants, central and local labs, IVRS/IWRS, and ancillary services to support protocol-aligned site operationsActively participated in site initiation, monitoring, and close‑out visits, ensuring readiness of documentation and addressing queries raised by sponsors or auditorsTracked protocol deviations, AEs, SAEs, and management of clinical study supplies on site in accordance with GCP and protocol standardsCoordinated AE/SAE reconciliation, including preparation, timely reporting to EC/sponsor, and cross-verification with site documentationCompleted electronic CRF entries in EDC (Medidata Rave, Oracle Clinical), resolving data clarification forms (DCFs) through robust query management and database reconciliationManaged administrative and regulatory tasks including ethics committee submissions, approvals, notifications, and amendments throughout the study durationMaintained the Trial Master File (TMF) in inspection-ready condition, aligned with GCP guidelines, ICH standards, and internal SOPsLiaised effectively with PI, Sub‑I, sponsor representatives, EC personnel, and cross-functional stakeholders to facilitate study operationsCompleted required sponsor-mandated training and participated in study meetings to stay aligned with protocol expectationsHandled investigational product (IP) dispensing and accountability, including storage, temperature documentation, and log maintenanceConducted source data documentation and record keeping, ensuring accurate transcription from patient files to electronic database and CRFsPerformed study close‑out and archiving, organizing and securing study records post-closeout in compliance with regulatory retention guidelines

Education

• LADY DOAK COLLEGE

  Bachelor of Science - BS

  2016 — 2019

• LADY DOAK COLLEGE

  Master of Science - MS

  2019 — 2021