Shiva Kumar

A resourceful self-starter individual with Clinical Research experience and strong collaborative skills, seeking opportunities in Clinical Research and related positions to utilize healthcare experience to meet the goals of the organization. Pursued M.Sc. in Biochemistry and 3+ years of experience in Clinical Research as Senior Clinical Research Associate Executive. Accomplished and dedicated CRA, known for ability to maintain essential documents, monitor subject safety, and ensure GCP compliance.

Demonstrated success in Trial Master File management, Ethics Committee submissions, source document review, and CAPA responses. Works as an integral team player with excellent communication skills.

Clinical Research Associate - Zenrise Clinical Research Pvt Ltd - Hyderabad, India

Sr. Executive Clinical Research Associate - Notrox Research Pvt Ltd. - Bangalore, Karnataka, India

Clinical Research Associate Executive - Notrox Research Pvt Ltd. - Bangalore, Karnataka, India

(2023-12 - 2026)

Responsibilities as a Clinical Research Executive.

• Monitoring safety of subjects during their in-house stay till post-study examinations.
• Maintaining essential documents including Protocol, Ethics Committee Approval, ICF, CRF, TMF, Investigational Product Documents, IB, and Amendments.
• Preparing study-related documents such as CRF and ICD as per in-house SOPs, sponsor requests, and applicable regulatory requirements.
• Responsible for monitoring source documents at site.
• Preparing and compiling Clinical Study Reports after completion of study as per in-house SOPs and guidelines reflecting raw data, for submission under Principal Investigator guidance.
• Preparing and submitting study dossier to Ethics Committee for review and approval before commencement of the study.
• Quality checking of raw data and the accuracy of the report.
• Compiling Trial Master File (TMF) before, during, and after completion of study as per TMF checklist and applicable SOPs.
• Responding to observations and findings from Quality Assurance by providing relevant Corrective/Preventive Action (CAPA).
• Registering and screening subjects using Clinical Management System software (VIMS).
• Initiating and completing clinical studies as per study plan to meet deadlines and timelines set by the sponsor.
• Ensuring all study-related activities are done under compliance of SOPs, GCP and other applicable regulatory requirements.
• Coordinating and participating in sponsor routine monitoring visits and study close-out visits.
• Reporting Adverse Events and SAEs to the PI and Sponsor within stipulated timelines.

M.Sc.

• Biochemistry - Sri Krishna Devaraya University, Anantapur, Andhra Pradesh (2022)

B.Sc.

• Biotechnology, Microbiology & Chemistry - SSBN Degree College, Anantapur, Andhra Pradesh (2020)

Intermediate - Deeksha Junior College, Yemmiganur, Andhra Pradesh (2017)

Secondary School (SSC) - Z.P.H.S, Yemmiganur, Andhra Pradesh (2015)