Revana Devarinti
Belagavi
Summary
Accomplished clinical trials administrator with expertise in ethical research conduct and regulatory compliance at the IEC of KLE Academy of Higher Education and Research. Proven track record in managing trial master files and facilitating ethics committee coordination. Skilled in conflict resolution and data management, enhancing operational efficiency and ensuring adherence to ICH-GCP standards.
Overview
10
10
years of professional experience
Work History
Administrator (Clinical Trials)
IEC of KLE Academy of Higher Education and Research
Belagavi
08.2023 - Current
- Ethics Committee Coordination: Schedule and organize the Ethics Committee (EC/IRB) meetings and ensure quorum compliance. Preparing and distributing the meeting agendas, study documentation, and minutes in accordance with regulatory timelines. Maintained up-to-date records of committee members, training, and conflict of interest declarations.
- Regulatory Compliance & Documentation: Reviewing and tracking clinical trial protocols, amendments, informed consent forms, and related documents. Monitored approval timelines and facilitated efficient communication between investigators and the EC.
- Trial Management Support: Coordinated clinical trial submissions, approvals, renewals, and reporting (e.g., SAE reporting, annual progress reports). Managed trial master files (TMF) and ensured completeness and compliance with regulatory standards. Liaised with sponsors, CROs, and investigators regarding site feasibility, trial activation, and documentation needs.
- Training & Policy Development: Assisted in the development and revision of SOPs related to ethics review and clinical trial administration. Facilitated training sessions for investigators and committee members on ethical guidelines and regulatory updates.
- Audit & Inspection Readiness: Supported internal and external audits, including those from regulatory agencies. Ensured all ethics and regulatory documentation was inspection-ready at all times.
RESEARCH PHARMACIST
KLE Research Pharmacy-KLES Dr.PK Hospital and MRC
Belagavi
12.2019 - Current
- Accurately dispensed IMP medications to patients and healthcare providers.
- Reviewed prescription orders to ensure safety and appropriateness.
Clinical Research Assistant/Assistant Professor – (Pharmacy Practice)
KLE College of Pharmacy-KLES Dr.PK Hospital and Medical Research Centre
Belgaum
01.2016 - Current
- Study Coordination & Implementation: Supported the planning, coordination, and execution of clinical research studies in compliance with ICH-GCP, institutional, and regulatory requirements.
- Data Management & Analysis: Maintained accurate, timely, and complete source documentation and case report forms (CRFs).
- Ethics & Regulatory Support: Preparing and submitting the ethics applications, amendments, and progress reports to the Institutional Review Board (IRB) or Ethics Committee. Ensured research protocols complied with institutional, national, and international regulatory standards.
- Teaching & Mentorship: Delivered lectures and tutorials in core subject areas relevant to clinical research & pharmacology. Supervised undergraduate and postgraduate research projects and mentored students in research activities.
- Clinical Research-Pharm D V Year
- Clinical Research-MSc in Clinical Research Program
- Drug Development and regulations-MSc in Clinical Research Program
- Pharmacovigilance and safety Monitoring-MSc in Clinical Research Program
- Fellowship and internships in Clinical Research
- Masters Students Guided >10
- Departmental Service: Participated in faculty development activities and institutional strategic planning initiatives.
Education
Ph.D. - Bioethics/Pharmacy Practice
KLE Academy of Higher Education & Research
Belagavi06.2025
B Pharmacy -
RGUHS
Bangalore, India06.2023
M Pharma - Pharmacology
JNTU-Kakinada
AP, India12.2015
Skills
- Clinical trial registry-CTRI
- Ethical research conduct
- Accreditation management
- Human ethics oversight
- Standard operating procedures
- Investigational medicinal product management
- ICH-GCP compliance
- Recruitment support strategies
- Conflict resolution techniques
- Regulatory compliance
- Handling of SUGAM Portal-EC & Clinical trials
Affiliations
Indian Society for Clinical Research, Annual (Clinical Research), 03/30/2024
Orcid
0000-0001-9785-6814
Publications
- Clinical trial participants' perspectives on genetic research data reuses for future research, current pharmacogenomics, and personalized medicine, 04/2024, 10.2174/0118756921305151240503075928
- Assessment of knowledge, attitude, and practices on genetic research data reuse for future research: clinical trial investigators' perspectives, Asian Journal of Pharmaceutical Research and Health Care, 03/27/2024, 10.4103/ajprhc.ajprhc_138_23
- National and international regulatory requirements on stem cell research: a systematic review, Indian Journal of Health Sciences and Biomedical Research KLEU, 01/31/2024
- Pharmaceutical sponsors and contract research organizations' perception toward genetic data reuse for future research, Perspectives in Clinical Research, 11/15/2023, 10.4103/picr.picr_220_22
- A retrospective study: root cause analysis of reported serious adverse events and development of corrective actions and preventive actions for deviated serious adverse event reports at a clinical trial site management office, International Journal of Clinical Trials, 07/21/2020, 10.18203/2349-3259.ijct20203106
Disclaimer
I hereby declare that the above-mentioned information is correct to the best of my knowledge, belief, and information and I bear the responsibility for the correctness of the above-mentioned particulars.
Training And Development
- Research Ethics online training, 10/16/2024, WHO ERC Secretariat, Global Health Ethics & Governance Unit
- Authoring Patient Narratives-Certification, 03/2024, ISCR
- Research Ethics Training (Bioethics), 07/11/2022, FERCAP
- Good Clinical Practice Certification, 02/12/2020, CDSA & BCIL at Pune
- NPTEL-Online Certification-Funded by the Ministry of HRD, GOI, 02/2018
- BLS-ALS Certification by the Department of Pharmacy Practice-Advanced Academic Training Program, 01/2024
Research
- Optimizing Antibiotic Use- A Patient-Centered, Prospective, Observational Study on Healthcare Professional Prescribing Practices, 2023
- Assessment of KAP of Patient and Attenders on Hepatitis-an Interventional study, 2024
- A Comparative Study on ICMR Stem Cell Guidelines with the USFDA regulatory requirements, 2021
- Challenges in clinical trial study Monitoring during COVID-19, 2020
- A retrospective study: root cause analysis of reported serious adverse event and development of corrective action and preventive action for deviated serious adverse event reports at a clinical trial site management office, 2019
Languages
Telugu
Native
Native
English
Proficient (C2)
C2
kannada
Proficient (C2)
C2
Marathi
Elementary (A2)
A2
Timeline
Administrator (Clinical Trials)
IEC of KLE Academy of Higher Education and Research
08.2023 - Current
RESEARCH PHARMACIST
KLE Research Pharmacy-KLES Dr.PK Hospital and MRC
12.2019 - Current
Clinical Research Assistant/Assistant Professor – (Pharmacy Practice)
KLE College of Pharmacy-KLES Dr.PK Hospital and Medical Research Centre
01.2016 - Current
Ph.D. - Bioethics/Pharmacy Practice
KLE Academy of Higher Education & Research
B Pharmacy -
RGUHS
M Pharma - Pharmacology
JNTU-Kakinada