Karthik Pudattu
Hyderabad
Summary
Over 10 years of experience in the clinical research industry. My seven years as a Clinical Research Associate have refined my skills in effectively managing clinical trials and ensuring strict compliance with regulatory standards. I am committed to driving excellence and advancing innovative healthcare solutions through my work.
Overview
11
11
years of professional experience
Work History
LEAD/SENIOR CLINICAL RESEARCH ASSOCIATE
Aurigene Oncology
Hyderabad
07.2022 - Current
- Oncology Phase I (4 ongoing studies) and Phase IIb/III (1 ongoing study), executing over 100 visits, including 50 Site Selection Visits (SSV) and 50 Site Initiation Visits (SIV), ensuring comprehensive oversight
- Supervise and mentor junior CRAs, providing guidance to ensure study activities comply with protocols and regulatory requirements
- Evaluate and select appropriate clinical trial sites by assessing staff qualifications, facility capabilities, and patient populations
- Ensure sites are adequately prepared with the necessary materials and training.
- Conduct regular site visits to monitor trial progress, verify data accuracy, and ensure compliance with Good Clinical Practice (GCP) guidelines and study protocols
- Oversee the accurate collection, verification, and reporting of clinical trial data, maintaining the integrity and reliability of study results
- Ensure all trial activities comply with local and international regulatory requirements, safeguarding participant rights and well-being
- Identify potential risks within trial processes and implement strategies to mitigate them, ensuring participant safety and data integrity
- Provide training to site staff and junior CRAs on study protocols, regulatory guidelines, and best practices to maintain high-quality standards across all trial sites
- Act as the primary liaison between sponsors, site staff, and regulatory bodies, facilitating effective communication and timely resolution of issues
- Maintain comprehensive and accurate trial documentation, including monitoring reports, regulatory submissions, and correspondence, ensuring readiness for audits and inspections
CLINICAL RESEARCH ASSOCIATE II AND STUDY START UP ASSOCIATE II
ICON Clinical Research
Chennai
09.2018 - 07.2022
- Extensive Monitoring Expertise across diverse countries: India, Malaysia, Hong Kong, Australia, and South Africa, spanning Phase II-IV clinical trials in critical Therapeutic Areas including Cardiovascular, Medical Devices, Endocrine, Hematology, Central Nervous System, Infectious Disease, and Inflammation
- Executed over 100 site visits, including 20 Pre-Study Visits (PSV) and 10 Site Initiation Visits (SIV), optimizing site engagement and operational efficiency
- Streamlined ethics approval processes, leading to accelerated study start-up
- All trial activities comply with local and international regulatory requirements, safeguarding participant rights and well-being
- Identify potential risks within trial processes and implement strategies to mitigate them, ensuring participant safety and data integrity
- Provide training to site staff and junior CRAs on study protocols, regulatory guidelines, and best practices to maintain high-quality standards across all trial sites
- Act as the primary liaison between sponsors, site staff, and regulatory bodies, facilitating effective communication and timely resolution of issues
- Maintain comprehensive and accurate trial documentation, including monitoring reports, regulatory submissions, and correspondence, ensuring readiness for audits and inspections
- Engineered and executed customized subject recruitment strategies, boosting project alignment and enhancing site engagement
- Delivered in-depth protocol training to site teams, fostering proactive communication and managing expectations effectively
CENTRAL MONITOR
IQVIA
03.2017 - 04.2018
- Expertly execute complex processes to deliver high-quality outcomes in data management and monitoring
- Establish and maintain effective project and site communications to ensure seamless collaboration
- Ensure the accurate completion and maintenance of internal systems, databases, tracking tools, timelines, and project-specific information
- Participate in document management, encompassing creation, review, maintenance, and secure storage
- Drive project analysis through the development of High-Risk Sites Analytics, serving as a critical reference for the team to achieve optimal resolutions
- Implement a Risk-Based Monitoring (RBM) approach to enhance the efficiency of clinical trials
- Conduct thorough eTMF reviews and quality checks to uphold compliance standards
- Prepare and review site visit reports post-visit to ensure comprehensive documentation
- Compile Information Site Packs to facilitate monitoring visits, summarizing site issues, aging queries, missing pages, AE/SAE, contact lists, and IP accountability
- Review and assess various monitoring systems, including CTMS, Infosario, ELVIS (eTMF), and IWRS, ensuring optimal data integrity and accessibility
CLINICAL RESEARCH COORDINATOR
JSS Medical Research Pvt Ltd (India)
03.2016 - 09.2016
- Performing enrolment, screening, randomization, and close out visits
- Ensuring timely submission of protocol/consent documents for ethics/IRB approval
- Coordinating and following up with the institution and the ethics committee
CLINICAL RESEARCH ASSOCIATE
Kentron Biotechnology Pvt Ltd.
12.2013 - 01.2016
- Conducted comprehensive Site Initiation, Monitoring, and Closeout Visits, ensuring adherence to regulatory standards
- Guaranteed timely submission of protocol and consent documents for ethical and IRB approval
- Collected and organized critical documents for effective EC/IRB submission and approval
- Played a key role in finalizing country and site Informed Consent Forms (ICF)
- Engaged in contract negotiations, successfully managing study budgets
- Ensured rigorous compliance with regulations, guidelines, and policies at assigned study sites
- Developed and implemented targeted recruitment strategies to achieve patient enrollment goals
- Collaborated with Clinical Study Teams to identify and resolve site quality and execution challenges
- Monitored site quality and performance metrics; devised solutions to enhance overall site effectiveness
- Ensured prompt communication and management of safety issues by the Principal Investigator and study team
- Created and executed effective corrective action plans for all identified quality issues at sites
- Maintained active participation with the study team to address evolving study needs, delivering timely site communications
- Demonstrated thorough knowledge of protocols and General Monitoring Guidelines in all activities
- Employed strong communication and prioritization skills, adapting swiftly to changes in work environment and study milestones with Project Manager support
Education
MASTER DEGREE - MICROBIOLOGY
Osmania University
BACHELOR DEGREE - MICROBIOLOGY, BIOCHEMISTRY, CHEMISTRY
Osmania University
Skills
- Microsoft Office suite
- EDC Tools: Oracle Inform
- EDC Tools: SIRO
- EDC Tools: Viedoc
- TMF
- Activate system
- CTMS
- Imagining ICL
Languages
- English
- Hindi
- Telugu
Timeline
LEAD/SENIOR CLINICAL RESEARCH ASSOCIATE
Aurigene Oncology
07.2022 - Current
CLINICAL RESEARCH ASSOCIATE II AND STUDY START UP ASSOCIATE II
ICON Clinical Research
09.2018 - 07.2022
CENTRAL MONITOR
IQVIA
03.2017 - 04.2018
CLINICAL RESEARCH COORDINATOR
JSS Medical Research Pvt Ltd (India)
03.2016 - 09.2016
CLINICAL RESEARCH ASSOCIATE
Kentron Biotechnology Pvt Ltd.
12.2013 - 01.2016
MASTER DEGREE - MICROBIOLOGY
Osmania University
BACHELOR DEGREE - MICROBIOLOGY, BIOCHEMISTRY, CHEMISTRY
Osmania University
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