Arsha V S
Thiruvananthapuram
Summary
- Skilled clinical research coordinator with background in managing and overseeing clinical trials. Experience includes coordinating with research teams, ensuring compliance with protocols, and managing participant recruitment and data collection processes.
- Possess strong organizational skills, hardworking with excellent communication and planning skills, ability to manage multiple tasks efficiently, and capability to ensure accuracy in documentation and reporting.
- Experienced in overseeing the regulatory, sponsored, academic, grant and DNB proposals submitted to Ethics committee for approval as per the ICMR and NDCT rules.
- Currently working at Narayana Health City, Bangalore as Clinical Research Coordinator and Ethics Committee Coordinator from october 2023.
Overview
1
1
year of professional experience
Work History
Clinical Research Coordinator
Narayana Health City
Bangalore
10.2023 - Current
- Assisted in the ICF process, Screening, Subject enrolment and Follow up.
- Good communication between Patients and other study staffs
- Completion and maintenance of Study logs, Case Report Forms and Source documentation.
- Assists with maintenance, updating and completion of Site Master File.
- Assisted in the preparation of Institutional Review Board submissions for clinical trials.
- Collected, processed and delivered specimens from trial participants.
- Comply with FDA, ICH and Schedule Y guidelines.
- Communicated effectively with investigators, study staff, sponsors, vendors, IRB personnel, and other stakeholders throughout the life cycle of the trial.
Ethics Committee Coordinator
Narayana Health City
Bangalore
10.2023 - Current
- Overseeing the regulatory, sponsored, academic, grant and DNB proposals submitted to Ethics Committee for approval as per the ICMR and NDCT rule.
- Organize investigator meetings; developed meeting agendas; created presentations; tracked action items from meetings; coordinated follow-up communications after meetings.
- Discussed job performance problems with employees, identifying causes and issues to find solutions.
- Maintained accurate records of committee activities and decisions.
- To keep all registration (DCGI, NABH, DHR, FWA, IORG etc) in place and renew them in a timely manner.
- Served as a liaison between the committee chairperson and other team members.
Clinical Research Coordinator Intern
Narayana Health City
Bangalore
04.2023 - 10.2023
Education
6 Month Diploma Course in Clinical Research
Orcigenix Life Science
Thiruvananthapuram01-2022
Master of Science - Biotechnology
Govt. Arts College
Thiruvananthapuram01-2022
Bachelor of Science - Botany
HHMSPB NSS College For Women
Thiruvananthapuram01-2020
Skills
- Research Coordination
- Data Management and Analysis
- Multitasking
- Regulatory Compliance
- Strong Communication Skill
- Time Management
- Problem-solving and Critical Thinking
- Adaptability
- Microsoft office: Word, Excel, Powerpoint
- Microsoft Teams
- Microsoft Outlook
ACHIEVEMENTS
- Presented a paper in an International Webinar on "Biotechnology-Recent advances, challenges & opportunities" organized by the Department of Biotechnology, University of Kerala, TVM
- Successfully passed Aptis test conducted by British Council under the auspices of the Govt. of Kerala with an overallCERF grade of B2
Languages
Malayalam
First Language
English
Advanced (C1)
C1
Hindi
Advanced (C1)
C1
Tamil
Intermediate (B1)
B1
Kannada
Elementary (A2)
A2
PROJECTS
- Remote Monitoring Evaluation with Cardiac Implantable devices compared to conventional devices without Remote monitoring.
- Non-invasive estimations of hemodynamic parameters for cardiac monitoring using CardioTag.
- Investigation of acquired mutations and exploratory blood biomarkers in Cardiovascular Disease (CVD) in Indian population.
- Collection of biosamples from patients suffering from Hematological Malignancies for Biobanking and Research purposes, sponsored by Brystol-Myers Squibb India Private Ltd.
- TrEatment Approach in the Multimodal era (TEAM) Registry, sponsored by ICA.
- Myval THV Registry.
- Safety and effectiveness of Edward's sapien 3 Transcatheter Heart Valve (THV) in Indian Population- Patient registry.
- A Retrospective, multicenter, real-world evidence study of open, laparoscopic and robotic-assisted staging surgery for Endometrial Cancer.
PERSONAL PROFILE
- Date of birth: 16-08-1999
- Nationality: Indian
- Gender: Female
- Marital status: Unmarried
Declaration
I solemnly declare that the information mentioned above is correct to the best of my knowledge and belief.
Timeline
Clinical Research Coordinator
Narayana Health City
10.2023 - Current
Ethics Committee Coordinator
Narayana Health City
10.2023 - Current
Clinical Research Coordinator Intern
Narayana Health City
04.2023 - 10.2023
6 Month Diploma Course in Clinical Research
Orcigenix Life Science
Master of Science - Biotechnology
Govt. Arts College
Bachelor of Science - Botany
HHMSPB NSS College For Women
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