Connection profile

Manasa Somireddy

About: Clinical Research Coordinator at Kairos R and D Solutions Pvt. Ltd. from Oct 2023-till now. > Experienced in Participant Screening & Enrollment, Informed Consent Documentation, Visit Coordination and trial participant scheduling, Adverse Event Monitoring & Reporting, Patient Safety & Rights, Follow-Up & Retention, ensured accurate data collection, source documentation, and timely entry into EDC systems. > Involved in Finance related activities which include Study Budget Awareness, Tracking Billable Activities, Invoice Support, Patient Reimbursement Oversight, Coordination with Sponsor/CRO, Support During CTA Review > Acted as liaison between the sponsor/CRO and site finance department for study-specific budget queries and documentation. > Coordinated and managed clinical trial activities for academic, sponsored as well as government-funded studies, ensuring compliance with ICH-GCP, institutional, and sponsor requirements. > Utilized multiple clinical research platforms including Veeva Vault, Veeva CDMS, OctalSoft, Clinical One, Medidata, Calyx MI, Firecrest, , ClinSPA, 4G Clinical, Bioclinica, and Clario for electronic data capture, eCRF completion, subject data entry, query management, site training, and study documentation > Managed lab supplies and patient kits by tracking inventory, arranging timely orders, monitoring storage conditions (including temperature), and maintaining accurate IP accountability records in compliance with protocol and regulatory requirements. > Participated in all phases of clinical trials, from study startup to closeout, including regulatory submissions, site initiation, patient recruitment, visit coordination, data entry, and archiving. SKILLS • Clinical Trial Coordination (Startup to Closeout), Multitasking Under Timelines, Team Collaboration, Attention to Detail, Query Resolution & Data Accuracy, Ethics & Regulatory Submissions. • Organizing Committee Member for TYACAN 2024(Teenage and Young Adult Cancer)-assisted in event planning and coordination.