Summary
Overview
Work History
Skills
Accomplishments
Enddate
Seminarsworkshopsconferences
Academicbackground
Keycontributionsachievements
Personalattributesprofessionalism
Mentorshipadvisoryroles
Startdate
Organization
Personal Information
Publications
References
Timeline
Generic

Ria Vijay

Mumbai, Ludhiana

Summary

Experienced Medical Writer and Clinical Research Specialist with a Master of Science in Biological Sciences and a postgraduate degree in Clinical Research. Combines a solid educational background with extensive practical expertise in clinical documentation, research methodologies, and regulatory compliance. Proven track record for producing high-quality scientific manuscripts and grant proposals, as well as developing detailed multicentre research protocols and comprehensive Standard Operating Procedures (SOPs) for biomedical research. Proven success in establishing research units and securing funding through impactful research proposals, significantly enhancing institutional research capabilities. Expertise includes designing and delivering training sessions on clinical research methodologies, ICH-GCP guidelines, and national ethical standards. Accomplished in facilitating research publications and regulatory submissions, contributing to institutional accreditation and research excellence. Known for exceptional organizational skills, effective management of multiple projects, and clear communication of complex medical concepts. A collaborative leader whose mentorship has fostered a productive research environment and advanced the professional development of researchers and clinicians across esteemed institutions.

Overview

4
4
years of professional experience

Work History

Internship Clinical Research Coordinator

Bhaktivedanta Hospital and Research Institute
Thane
01.2022 - 06.2022
  • A Phase IV lung cancer trial to evaluate the safety and efficacy of the drug- Dacomitinib
  • (Pfizer) - A study to evaluate accuracy of a digital platform that validates early risk and severity of Non-alcoholic Fatty Liver Disease (NAFLD) and disease management approach in Indian NAFLD patients
  • (in collaboration with IIT, Bombay)
  • Assisted Principal Investigator in preparing the Protocol, Case Report Forms and Informed Consent Documents for IRB submissions and other regulatory submissions
  • Worked on developing patient databases for study purpose
  • Assisted Investigator in Manuscript writing for Investigator Initiated General Surgery studies and studies initiated by Histopathology and Anaesthesia department at the site for publication
  • Coordinated with different stakeholders in Clinical Trials.

Research associate

Biolim Institute of Science and Technology
Chennai
06.2021 - 07.2021
  • Project: Genes responsible for cancer induction

Summer intern

Verka milk plant
Ludhiana
05.2018 - 06.2018
  • Worked in the quality (microbiology) and production department

Clinical Research Associate

Bhaktivedanta Hospital and Research Institute
Thane
  • Experienced Medical Writer and Clinical Research Specialist with a Master of Science in Biological Sciences and a postgraduate degree in Clinical Research
  • Combines a solid educational background with extensive practical expertise in clinical documentation, research methodologies, and regulatory compliance
  • Proven track record for producing high-quality scientific manuscripts and grant proposals, as well as developing detailed multicentre research protocols and comprehensive Standard Operating Procedures (SOPs) for biomedical research
  • Proven success in establishing research units and securing funding through impactful research proposals, significantly enhancing institutional research capabilities
  • Expertise includes designing and delivering training sessions on clinical research methodologies, ICH-GCP guidelines, and national ethical standards
  • Accomplished in facilitating research publications and regulatory submissions, contributing to institutional accreditation and research excellence
  • Known for exceptional organizational skills, effective management of multiple projects, and clear communication of complex medical concepts
  • A collaborative leader whose mentorship has fostered a productive research environment and advanced the professional development of researchers and clinicians across esteemed institutions.

Skills

  • Experienced Medical Writer
  • Clinical Research Specialist
  • Clinical documentation
  • Research methodologies
  • Regulatory compliance
  • Producing high-quality scientific manuscripts
  • Grant proposals
  • Developing research protocols
  • Standard Operating Procedures (SOPs)
  • Designing and delivering training sessions
  • ICH-GCP guidelines
  • National ethical standards
  • Facilitating research publications
  • Exceptional organizational skills
  • Effective project management
  • Clear communication
  • Mentorship
  • Research methodology
  • Biomedical health research projects
  • Research proposal and funding
  • Establishment of research units
  • Development of training modules and SOPs
  • Facilitation of research publications
  • Regulatory submissions and accreditation
  • Effective communication and collaboration
  • Advisory roles

Accomplishments

  • Instrumental in getting Scientific industrial research organization accreditation in June 2023
  • Appreciation of the year award for being an instrumental in accreditation by ministry of science and technology on 08/03/23
  • Hosted Audit by Ministry of Science and Technology for scientific industrial research organization by 12/07/23
  • Employee of the year award on 01/11/24
  • Appointed as honorary consultant for developing DCGI accredited Ethics Committee for clinical trials dated 05/31/24.

Enddate

Present

Seminarsworkshopsconferences

  • Annual Institute Research Conference, 04/01/23, Research Methodology
  • Annual Institute Research Conference, 04/01/24
  • Research Methodology Workshop for Medical Students for Latur Medical College, 02/02/24
  • Invited Speaker on ICH GCP at Holy Spirit Hospital for consultants, 02/12/24
  • Invited Speaker on integrated Medicine Research Projects and collaborative research projects at Sri Satya Sanjivani Hospital, Mumbai, 04/04/24
  • Research Methodology Workshop Bsc -Psychology students from Amity University Mumbai, 04/27/23
  • Impact of biomedical heath research projects on Evidence based medical practice, 05/15/24
  • Invited Speaker on Research Methodology at Holy Spirit Hospital senior doctors, 03/16/24
  • Invited Speaker on Research Methodology at Holy Spirit Hospital Medical Students, 03/16/24
  • Invited Speaker on Research Methodology at Holy Spirit Hospital for Ethics Committee, 06/29/24

Academicbackground

holds a Master of Science degree in Biological Sciences and has further advanced her expertise through a postgraduate degree in Clinical Research. This solid educational foundation has been instrumental in shaping her proficiency in clinical documentation, research methodologies, and regulatory compliance. Her academic qualifications, coupled with extensive hands-on experience, makes her exceptionally well-equipped to handle the complexities of medical writing and research in a hospital environment.

Keycontributionsachievements

  • Establishment of Research Units
  • Development of Training Modules and SOPs
  • Facilitation of Research Publications
  • Regulatory Submissions and Accreditation

Personalattributesprofessionalism

-is a professional whose dedication to her work is evident in everything she does. Her exceptional organizational skills allow her to manage multiple projects simultaneously while maintaining a high standard of accuracy and quality. Her ability to conduct thorough literature reviews and synthesize complex information is a testament to her expertise in evidence-based medical writing. Her effective communication and collaboration skills are also worth noting. -excels in conveying complex medical concepts clearly and effectively, both in writing and in their interactions with colleagues, researchers, and trainees. Her collaborative approach fosters a productive and supportive work environment, enhancing the overall success of research projects and training initiatives.

Mentorshipadvisoryroles

-has been a mentor and advisor to many esteemed tertiary care hospitals and medical institutions in Mumbai. She has provided invaluable guidance in developing clinical research departments and have contributed significantly to the professional development of researchers and clinicians through her training and mentorship.

Startdate

10/01/22

Organization

Bhaktivedanta Hospital and Research Institute

Personal Information

Title: Clinical Research Associate

Publications

Prevalence of diabetes distress and its psychosocial determinants among Indian population with type II diabetes, International Journal of Research in Medical Sciences, 12, 3, 789–795, 2024, https://doi.org/10.18203/2320-6012.ijrms20240519

References

Dr Vijaykumar Gawali, Head - Clinical Research & Academics, Bhaktivedanta Hospital and Research Institute, 9320199122, drvjaykumar.g@bhaktivedantahospital.com

Timeline

Internship Clinical Research Coordinator

Bhaktivedanta Hospital and Research Institute
01.2022 - 06.2022

Research associate

Biolim Institute of Science and Technology
06.2021 - 07.2021

Summer intern

Verka milk plant
05.2018 - 06.2018

Clinical Research Associate

Bhaktivedanta Hospital and Research Institute
Ria Vijay