An internationally trained medical professional with a strong foundation in healthcare and clinical research. Experienced in patient care, clinical trial coordination, and regulatory compliance, with a deep understanding of ICH-GCP, FDA, and IRB guidelines. Skilled in patient recruitment, informed consent, data collection, and adverse event reporting. Passionate about contributing to high-quality clinical research while ensuring patient safety and protocol adherence.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator Intern,Remote
The CRC Academy
Irvine
06.2023 - 07.2024
Attained a strong understanding of human subject protection for clinical trials, ethical and regulatory compliance with the US FDA, ICH-GCP regulatory requirements, IRB functions, HIPAA, and more.
Took vital signs and collected medical histories as part of study protocols.
Performed patient assessments, collected and analyzed data, and prepared reports.
Streamlining clinical trial processes from site initiation to closeout, while mastering IVRS/IWRS systems and regulatory binder review procedures.
Creating protocol-compliant screening documents, and implementing timely reporting systems for serious adverse events, while supporting site compliance requirements.
Analyzing efficacy and safety reports for development products while gaining comprehensive knowledge in IRB submission processes and regulatory compliance protocols.
Implementing protocol-compliant screening procedures, and developing expertise in source data verification, while maintaining comprehensive regulatory binders.
Resolving CRF queries according to ALCOA-C guidelines, while supporting site compliance from initiation through closeout phases of clinical trials.
Medical Officer/Duty Doctor
Bharath Cancer Hospital and Research Institute
Mysore
06.2008 - 10.2010
Executed comprehensive patient monitoring including vital signs assessment, follow-up care documentation, and adverse event tracking while maintaining meticulous clinical records for research integrity.
Performed various medical and surgical procedures including IV cannulation, urinary catheterization, paracentesis, intramuscular injections, repairs to lacerations and sutures while meticulously documenting patient responses and adverse events.
Provided comprehensive patient education on treatment protocols and disease management, developing individualized counseling approaches for pain management and recovery.
Led training initiatives for therapy teams while implementing strategic action plans that enhanced clinical practice standards and treatment outcomes.
Facilitated cross-functional coordination between research and clinical teams, ensuring seamless implementation of trial protocols and timely documentation of results.
Maintain complete, accurate and timely data and essential clinical documents in systems utilized for trial management using CRF.
Implementation of the clinical trial from initiation through the stages of development documents, SOPs and organization facilities.
Medical Officer/Duty Doctor
Raman Memorial Hospital
Mysore
07.2007 - 05.2008
Managed comprehensive patient documentation, including consent forms, case narratives, and medical histories, while performing essential procedures such as cannulation and catheterization.
Diagnosed conditions through systematic examination and investigation, developing evidence-based treatment regimens with carefully calibrated prescriptions, and follow-up protocols.
Examined patients, decided the course of treatment, and provided follow-up care to observe prognosis and adverse event experience.
Performed various medical and surgical procedures, including IV cannulation, urinary catheterization, intramuscular injections, repairs to lacerations, and sutures.
Supported the top management in proper analysis and submission of data regarding patient satisfaction, leading to a significant increase in the patient satisfaction level.
Coordinated patient care across medical floors, implementing structured triage protocols that improved clinical response times, and enhanced patient monitoring systems.
Facilitated interdisciplinary consultations among healthcare professionals, creating cohesive treatment plans that addressed complex patient needs.
Monitored patients' clinical progress daily, documenting case histories and treatment responses, while examining patients and determining appropriate treatment courses.
Analyzed patient satisfaction data to identify improvement areas, resulting in significant satisfaction metric increases, while managing comprehensive documentation, and performing essential medical procedures.
Education
Bachelor of Ayurvedic Medicine and Surgery (B.A.M.S) -