Rohini Raghavan
Bengaluru
Summary
Highly experienced in clinical research management, with comprehensive knowledge of coordinating human ethics committee functioning, regulatory requirements and clinical trial operations.
Strengths include protocol development, procuring approvals, strategic planning and execution of research study conduct. An individual with focus on team leadership and process improvement initiatives to enhance efficiency, data accuracy and study performance.
Overview
17
17
years of professional experience
Work History
Research Manager
Cloudnine Group of Hospitals
Bengaluru
08.2018 - Current
- Managing Human Ethics Committee activities to ensure alignment with CDSCO & NECRBHR requirements
- Efficiently organized all required procedures for a seamless EC registration process with CDSCO and NECRBHR
- Facilitating review meetings, recording decisions, and effectively communicating with multiple stakeholders
- Managing dossier drafting and screening responsibilities for review meetings
- Preparation and presentation of research proposal summaries to the Ethics Committee and management
- Efficiently leading teams in conducting and concluding multiple multicentric research trials and qualitative studies, ensuring the prompt delivery of accurate data
- Drafting, vetting of precise and legally appropriate trial agreements, material transfer agreements (MTA) Memorandum of Understanding (MoU), service agreements, and non-disclosure agreements for research studies
- Managing budgets related to research projects; ensuring accuracy in invoicing procedures
- Obtaining ICMR and HMSC approvals for research studies as needed
Research Data Manager
St. John's Research Institute
Bengaluru
07.2009 - 01.2018
- Established a cohort of 400+ breast cancer patients from various centers
- Achieved accurate compilation and management of data from a variety of sources
- Managed dossier preparations, ensuring adherence to ethical guidelines and obtaining approvals from Ethical Review Boards.
- Managed and achieved end-to-end execution of qualitative research studies
- Developed extensive database and implemented efficient centralized records system.
- Created concise and informative reports on patient progress and outcomes for senior management.
Clinical Research Associate
Connexios Life Sciences Pvt. Ltd.
Bengaluru
08.2007 - 06.2009
- Took charge of end-to-end management for qualitative research studies
- Drafted study dossiers, managed Ethics Committee submissions and obtained necessary approvals
- Evaluated participant eligibility, identified potential research subjects and guided them through the informed consent procedure
- Ensured accuracy of collected data prior to database lock; resolved discrepancies as needed
- Created comprehensive database for efficient management of patient-centric records, specimen collection, and storage
Education
Foundation course in Research Methodology -
St. John’s Medical College Research Society
Bengaluru03.2015
PG Diploma in Clinical Research & Trial Management -
Institute of Clinical Research India
Bengaluru04.2007
Master of Science - Microbiology
University of Mysore
Mysore, KA06-2003
Skills
- Ethics Committee Secretariat
- Protocol development
- Research project planning, execution and management
- Data evaluation
- Regulatory submissions & compliance
Workshops & Conferences
- Introduction to Pediatric Bioethics - Apr 2024, SJMCH, Bengaluru
- Good Clinical Practice (GCP) Workshop for Ethics Committee Members, Jul 2022, Indian Society for Clinical Research (ISCR)
- National Symposium on Bioethics & Good Clinical Practice, Sep 2021, SRM Medical College Hospital & Research Centre, TN
Timeline
Research Manager
Cloudnine Group of Hospitals
08.2018 - Current
Research Data Manager
St. John's Research Institute
07.2009 - 01.2018
Clinical Research Associate
Connexios Life Sciences Pvt. Ltd.
08.2007 - 06.2009
Foundation course in Research Methodology -
St. John’s Medical College Research Society
PG Diploma in Clinical Research & Trial Management -
Institute of Clinical Research India
Master of Science - Microbiology
University of Mysore
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