Sendhil Kumar
CRA | CRC | Data Entry Operator | IQVIA cFSP AstraZeneca | CliniRx | Haematological Cancer Consortium | MSc Clinical Research | Bsc Anaesthesia Technology |
- Role
- Clinical Research Associate at IQVIA India
- Location
- Chennai, TN, IN
- LinkedIn followers
- 500 followers
About Sendhil Kumar
Clinical Research Associate with a Master\'s in Clinical Research and a Graduate in Anaesthesia Technology from Narayana Hrudayalaya at RGUHS. Committed to be advancing healthcare through quality clinical trials.
Experience
Clinical Research Associate
Nov 2025 — Present · IN
Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordancewith contracted scope of work and regulatory requirements, i.e, Good Clinical Practice (GCP) andInternational Conference on Harmonization (ICH) guidelines.Work with sites to adapt, drive and track subject recruitment plan in line with project needs toenhance predictability.Administer protocol and related study training to assigned sites and establish regular lines ofcommunication with sites to manage ongoing project expectations and issues.Evaluate the quality and integrity of study site practices related to the proper conduct of the protocoland adherence to applicable regulations. Escalate quality issues as appropriate.Manage the progress of assigned studies by tracking regulatory submissions and approvals,recruitment and enrollment, case report form (CRF) completion and submission, and data querygeneration and resolution. May support start-up phase.Ensure copies/originals (as required) site documents are available for filing in the Trial Master File(TMF) verify that the Investigator\'s Site File (ISF) is maintained in accordance with GCP / ICH and localregulatory requirements.Create and maintain appropriate documentation regarding site management, monitoring visit findingsand action plans by submitting regular visit reports, generating follow-up letters and other requiredstudy documentation.Collaborate and liaise with study team members for project execution support as appropriate.If applicable, may be accountable for supporting development of project subject recruitment plan on aper site basis.If applicable, may be accountable for site financial management according to executed clinical trialagreement and retrieve invoices according to local requirement.
Education
Rajiv Gandhi University of Health Sciences
Bachelor's degree, Anaesthesia Technologist
2014 — 2018
Rajiv Gandhi University of Health Sciences
Master's in clinical research, Research
2019 — 2021
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