Central Review Manager
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Currently, Central Review Manager with almost 3 years of experience as Clinical Research Associate, and over a year of experience as a Research Coordinator/Clinical Trial Assistant. As CRA worked as both blinded and unblinded monitor on more than 4 clinical trials in Cardiology/Vascular diseases, Dermatology and Rare/Genetic Diseases therapeutic areas.
Coordinator, worked on 5 clinical trials in Dermatology, Devices, Hematology/Oncology and Vaccine therapeutic areas. Experienced in clinical trials phases I-IV in adult and pediatric population. Used different clinical and/or client specific systems for trial management, such as EDC, CTMS, IVRS, IWRS, eDiaries and participated in several site audits, local authority inspections and supported investigative site in preparation for an FDA inspection.
Mentored junior CRAs, supported project management with assigned tasks and reviewed monitoring reports. Performed 100% SDV and reduced SDV, on-site and remote visits.
Central Review Manager - PPD - Bengaluru, India
(2022-06)
Performs review of clinical monitoring visit reports ensuring consistency across protocols and/or regions and escalates any protocol, site, and/or CRA issues or trends noted during the report review process to CTM. Liaises with CRA for prompt trip report review submission and approval as per the stipulated timelines of PPD and/or the Sponsor. Evaluates PI oversight (e.g., protocol adherence), subject safety and study processes to assess site's ability to conduct study, as ascertained from information noted in monitoring visit reports and associated electronic data systems.
Provides trial MVR status tracking and progress update reports to CTM/CRA as required.
Clinical Research Associate - IQVIA RDS INDIA PVT.LTD - Bengaluru, India
(2021-04 - 2021-08)
Clinical Research Associate on a clinical trial in Dermatology (Diabetic foot ulcer), Phase III, randomized, double blind, parallel group, vehicle controlled, multicentered study in adult population. Developed strategies with physicians to prioritize patient care in conjunction with the goal of enrolling patients into studies. Proactively contributed to delivery of project expectations and milestones.
Ensured regulatory compliance with FDA and Ethical guidelines, study protocol and all related SOPs. Worked on SDV completion, CIFs review, proactive resolution of issues related to quality and effective risk management at site, monitoring and project levels. Managed compliance to draft SVR submission and SVR finalization.
Performed remote monitoring visits using EDC, IWRS for IP management and reviewed monitoring visit reports as well.
Clinical Research Associate - JSS MEDICAL RESEARCH INDIA PVT.LTD - Chennai, India
(2018-01 - 2020-06)
Clinical Research Associate on 3 clinical trials in Cardiology/Vascular diseases (coronary artery disease), Dermatology (Diabetic Foot ulcer) and Rare/Genetic Diseases (prophylaxis and treatment of bleeding episodes in previously treated patients with moderate or severe Hemophilia), Phases I-III, parallel group, multicenter, open label, randomized, vehicle controlled in adult population. Unblinded monitor for Dermatology study. Excellent knowledge of clinical monitoring, gained exposure on overall site management including site selection, site initiations, site monitoring's and close outs.
Assisted in the stem cell therapies study for the development of protocols, case report forms, informed consent forms and IRB materials. Ensured regulatory compliance with FDA and Ethical guidelines, study protocol and all related SOPs, and maintained audit readiness at the site level with appropriate documentation of investigator site files and identical trial master file. Had Basic knowledge of International Conference on Harmonization (ICH) and Good Clinical Practice (GCP), Passed the Expert GCP NIIDA Clinical Trials Network.
Demonstrated ability to evaluate medical research data and proficien
Research Coordinator/Clinical Trial Assistant - MADHA DENTAL COLLEGE & HOSPITAL - Chennai, India
(2016-08 - 2017-12)
Assisted in the development of protocols, case report forms, informed consent forms and IRB materials. Communicated between trial sites and sponsor. Maintained audit readiness at the site level with appropriate documentation of Investigator site files and identical Trial Master File.
Reviewed IRB for assigned studies, ensuring compliance to the protocol processes, timelines, applicable SOPs, and GCP guidelines. Reviewed documents to ensure findings requiring corrective and/or preventative action plans were documented and followed up to resolution, to ensure high quality reports. Gained experience in 5 clinical trials in Dermatology (Diabetic foot/leg ulcers, Paronychia (Chemotherapy associated)) and Hematology/Oncology (Prostate cancer), Phases II-III, open label, rescue study in evaluating the safety and efficacy of XXX drug in adult population.
Also assisted clinical studies in Vaccine (T-dap to assess the immunogenicity and safety of Tdap vaccine in comparison with XXX vaccine) and Devices (observational cohort study to evaluate Cerebral aneurysm flow results in occlusion), Phases III-IV, multicenter, randomized, open label, active controlled, non-interventional, observational c
PGDPH - Public Health - Annamalai University (2019-06)
BDS - Dental surgery - Tamil Nadu Dr. M.G.R university (2016-10)
