SUSANNA JOSE PUTHENPURAYIL
Mumbai
Summary
Health care professional with extensive experience in dentistry and clinical research, offering a unique perspective in clinical trial management. Proven track record in documenting and supporting clinical trials, ensuring compliance.Strong written communication skills facilitate effective collaboration within project teams. Committed to optimizing resources and enhancing efficiency in research processes.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Clinical Research Associate
National Cancer Grid( NCG CRO),Tata Memorial Hospital
Mumbai
09.2024 - Current
- Ensured protocol, regulatory, and GCP compliance across multiple oncology sites in India.
- Executed regular on-site monitoring visits to address site queries and maintain compliant and up-to-date study files.
- Drafted monitoring plans and supported regulatory documentation and submissions.
- Verified data accuracy, reviewed patient records, and identified discrepancies before database lock.
- Monitored adverse events to ensure subject safety and complied with SOPs for safety reporting.
- Monitored and verified investigational product accountability, storage conditions, and site compliance in accordance with protocol and regulatory guidelines
- Coordinated communication among research teams, sponsors, investigators, and external stakeholders.
- Trained site personnel on GCP standards and study requirements to enhance compliance.
Clinical Research Co-ordinator
Bhakti Vedanta Hospital and Research Institute
Thane
06.2023 - 08.2024
- Actively involved in both Global Clinical trials and Investigator-Initiated trials from the site initiation to site close out.
- Preparation and documentation of trial activities, viz., study patient visits, serious adverse events, safety reports, monitoring, and audits, by adhering to the protocol, ICH-GCP, and NDCT guidelines, coordination with the Ethics Committee under the supervision of the Principal Investigator.
- Electronic documentation of patient-related information in the sponsor-provided portal (EDC).
- Participating and presenting in department seminars.
- Active participation in protocol design, manuscript writing, and the publication process and authored papers in scientific journals.
- Trial indications include Neurology, Oncology, Dermatology and Thanatology projects.
- Coordinated clinical trial activities and ensured compliance with regulatory guidelines.
- Managed patient recruitment and maintained participant databases for research studies.
- Oversaw data collection processes and ensured accuracy of clinical documentation.
- Assisted in the preparation of Institutional Review Board submissions for clinical trials.
Medical Data Analyst
Vasta Bio-informatics PVT LTD
Navi-Mumbai
08.2021 - 12.2022
- Analyzed complex medical data to support clinical trials and research projects.
- Developed and maintained databases for efficient data retrieval and management.
- Conducted quality checks to ensure accuracy of datasets used in studies.
- Contributed actively to team meetings and learning sessions to enhance collaboration.
- Ensured compliance with HIPAA regulations by adhering to protocols for managing sensitive patient information.
- Abstracted data with quality and production focus for oncology patient cohorts using specific tools.
General Dentist
Total Dental Care PVT LTD
Mumbai
05.2019 - 07.2021
- Worked as a general dentist at a corporate chain of dental clinics.
- Maintained compliance with industry regulations and standards by staying informed about changes in laws or new guidelines for dentistry practices.
- Improved patient satisfaction by providing comprehensive dental care and personalized treatment plans.
Hon Sr. House Surgeon
Christian Medical College and Hospital
Vellore
03.2018 - 03.2019
- Performed routine dental checkups, identified, and treated oral health issues promptly to prevent further complications.
- Provided timely tobacco cessation counselling to habit patients.
- Assisted Oral Surgeons in minor surgeries.
- Participated and presented special cases in department weekly seminars.
Education
Post Graduation in Clinical Research - Clinical Research
Bhakti Vedanta Hospital And Research Institute
Thane09-2024
Certificate - General Dentistry
Christian Medical College And Hospital
Vellore03-2019
Bachelor of Dental Surgery - Dentistry
Bapuji Dental College And Hospital
Davangere03-2017
Skills
- GCP compliance and ICH guidelines
- Data accuracy verification
- Research methodology and protocol development
- Medical data analysis and quality control
- Effective communication and training
- Source document verification
- Site management
- Monitoring visits
- Informed consent process
- Clinical data management
Certification
• BIRAC -CTN Clinical Trial Training, National Cancer Grid, 01/2024
• Annual short course in Clinical Research Methodology, Tata Memorial Centre, Mumbai
• NIDA-GCP -Tracee Williams, Training Co-Ordinator, NIDA Clinical Co-Ordinator Center, 09/2024
• NDCT 2019 Guidelines, Bhakti Vedanta Hospital and Research Institute, 01/2023
• Annual short course in Clinical Research Methodology, Tata Memorial Centre, Mumbai
• NIDA-GCP -Tracee Williams, Training Co-Ordinator, NIDA Clinical Co-Ordinator Center, 09/2024
• NDCT 2019 Guidelines, Bhakti Vedanta Hospital and Research Institute, 01/2023
Accomplishments
- Star Performer, 09/2022, Vasta Bio-informatics PVT LTD
- Best scientific presentation, 01/2015, National level conference, IAOMR
Scientific Presentations
- Cancer Associated Fibroblast -The dark side of the coin, IAOMR, Calicut, 01/2016
- Target Therapy - A Magic bullet for Malignancy, IAOMR, Chennai, 01/2015
- Oral Manifestations of End stage renal disease, IAOMR, Bangalore, 01/2014
Membership
Lifetime Member of Indian Society of Clinical Research (ISCR)
Timeline
Clinical Research Associate
National Cancer Grid( NCG CRO),Tata Memorial Hospital
09.2024 - Current
Clinical Research Co-ordinator
Bhakti Vedanta Hospital and Research Institute
06.2023 - 08.2024
Medical Data Analyst
Vasta Bio-informatics PVT LTD
08.2021 - 12.2022
General Dentist
Total Dental Care PVT LTD
05.2019 - 07.2021
Hon Sr. House Surgeon
Christian Medical College and Hospital
03.2018 - 03.2019
Post Graduation in Clinical Research - Clinical Research
Bhakti Vedanta Hospital And Research Institute
Certificate - General Dentistry
Christian Medical College And Hospital
Bachelor of Dental Surgery - Dentistry
Bapuji Dental College And Hospital