Hi, I’m
Prakriti Neupane
Scarborough,ON
Summary
Accomplished Clinical Research Associate with 5 years of experience performing and documenting pre-study site evaluations, regulatory document collection, interim monitoring and study close-out visits. Diligent in performing studies aligned with good clinical practices, study-specific requirements and clinical monitoring plans. In-depth knowledge of company procedures, regulatory requirements and quality standards.
Overview
6
years of professional experience
Work History
JSS Medical Research Pvt Ltd, Kollam, Kerala
Clinical Research Associate
2022.02 - 2023.05 (1 year & 3 months)
Job overview
- Act as a monitor of specific sites on a Clinical Research Study
- Facilitate preparation and collection of site level documents for Regulatory submission dossiers
- Preparation of EC dossiers and responding to EC queries
- Performing quality check of Trial Master Files
- Contribute in creating Local Working Procedures
- Assisting managers for reporting project activities as and when required
- Ensure site activities in line with milestones (i.e Start-up, recruitment, closeout, etc.,)
- Budgets and contracts
- Performing Trial feasibilities
- Performing Site Selection visits
- Performing Site Initiation visits
- Perform Monitoring visits according to Monitoring plan
- Prepare Study Reports (Confirmation, Monitoring &
- Follow up reports)
- Conduct Trial Site Training activities
- Facilitate site Drug Supply Management
- Drug Accountability & Reconciliation
ClinWorld Pvt Limited/Sami-Sabinsa Group Limited, Bangalore, Karnataka
Clinical Research Associate
2017.08 - 2021.11 (4 years & 3 months)
Job overview
- Act as a monitor of specific sites on a Clinical Research Study
- Facilitate preparation and collection of site level documents for Regulatory submission dossiers
- Preparation of EC dossiers and responding to EC queries
- Performing quality check of Trial Master Files
- Contribute in creating Local Working Procedures
- Assisting managers for reporting project activities as and when required
- Ensure site activities in line with milestones (i.e
- Start-up, recruitment, closeout, etc.,)
- Budgets and contracts
- Performing Trial feasibilities
- Performing Site Selection visits
- Performing Site Initiation visits
- Perform Monitoring visits according to Monitoring plan
- Prepare Study Reports (Confirmation, Monitoring & Follow up reports)
- Conduct Trial Site Training activities
- Facilitate site Drug Supply Management
- Drug Accountability & Reconciliation
- Medical Writing (Manuscript, Protocol, IB, ICF)
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
Education
Rajiv Gandhi University of Health Sciences , Bangalore, Karnataka, India
Pharm.D (Doctor of Pharmacy) from Pharmacy
06.2017
Skills
- Clinical Research Monitoring
- Detailed Documentation
- Data Collection
- Investigator Meetings
- Monitoring Visits
- Project Management
- Protocol Adherence
- Trip Reports
- Patient Safety
- Schedule Monitoring
- Clinical Documentation
- Managing Adverse Events
- Research Skills
- Clinical Operations
- Microsoft Excel
- Good Clinical Practice (GCP)
- Institutional Review Board (IRB)
- Medical Devices
- Pharmaceutics
- Vaccines
- Interventional Cardiology
Additional Information
- Majeed M, Majeed S, Nagabhushanam K, Mundkur L, Neupane P, Shah K. Clinical Study to Evaluate the Efficacy and Safety of a Hair Serum Product in Healthy Adult Male and Female Volunteers with Hair Fall. Clin Cosmet Investig Dermatol. 2020;13:691-700 https://doi.org/10.2147/CCID.S271013
- Majeed M, Majeed S, Jain R, Mundkur L, Rajalakshmi HR, Lad PS, Neupane P. An Open-Label Single-Arm, Monocentric Study Assessing the Efficacy and Safety of Natural Pterostilbene (Pterocarpus marsupium) for Skin Brightening and Antiaging Effects. Clin Cosmet Investig Dermatol. 2020;13:105-116 https://doi.org/10.2147/CCID.S238358
- Majeed, M.; Majeed, S.; Jain, R.; Mundkur, L.; Rajalakshmi, H.R.; Lad, P.; Neupane, P. A Randomized Study to Determine the Sun Protection Factor of Natural Pterostilbene from Pterocarpus Marsupium. Cosmetics 2020, 7, 16. https://doi.org/10.3390/cosmetics7010016
- Muhammed Majeed, Sankaran Natarajan, Sarang Bani, Anjali Pandey, Prakriti Neupane. Mutagenic, Genotoxic and Sub Chronic Oral Safety Analysis of Boswellia Serrata Extract (Boswellin ® Super). International Journal of Research Studies in Medical and Health Sciences. 2020, 5(7):20-32. 27 August. 2020.
- Muhammed Majeed, Sarang Bani, Beena Bhat, Anjali Pandey, Lakshmi Mundkur, Prakriti Neupane, Safety profile of 40% Garcinol from Garcinia indica in experimental rodents,Toxicology Reports, Volume 5, 2018, Pages 750-758, ISSN 2214-7500, https://doi.org/10.1016/j.toxrep.2018.06.009
Specialized Trainings
- Mar 2023 ICH GCP (E6)
- Mar 2022 New Drugs & Clinical Trial Rule, 2019 Mar 2022
- 21 CFR part 11 Mar 2022
- Indian GCP - ICMR Mar 2022 ISO 14155: 2011 (JSS Medical Research India Private Limited)
- Mar 2022 ISO 9001: 2015 (JSS Medical Research India Private Limited)
- Mar 2022 ICH GCP (E3) Mar 2022
- EDC (Clinion) : JSS Medical Research Asia Pacific Private Limited
Therapeutic Experience
1. Cardiology- device Phase IV
2. Diabetes Phase III
3. Psoriasis Phase III
4. Metabolic Syndrome Phase III
5. Gas and Bloating Phase III
6. Non-Alcoholic Steatohepatitis Phase III
7. Osteoarthritis Phase III
8. Stress and Anxiety Phase III
9. Weight management Phase III
10. COVID-19 Nutraceuticals, Phase III
11. Glaucoma Phase III
12. Skin Brightening and SPF determination Cosmeceuticals
Personal Attitude and soft skills
- Patience
- Logical thinking
- Empathy
- Honest and hard working
- Positive attitude and optimistic
- Desire to learn new things
- Punctual and flexible
- Quick learner
Timeline
Clinical Research Associate
JSS Medical Research Pvt Ltd
2022.02 - 2023.05 (1 year & 3 months)
Clinical Research Associate
ClinWorld Pvt Limited/Sami-Sabinsa Group Limited
2017.08 - 2021.11 (4 years & 3 months)
Rajiv Gandhi University of Health Sciences
Pharm.D (Doctor of Pharmacy) from Pharmacy
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