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 LtdKollam, Kerala
Clinical Research Associate
02.2022 - 05.2023
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 LimitedBangalore, Karnataka
Clinical Research Associate
08.2017 - 11.2021
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 SciencesBangalore, 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
02.2022 - 05.2023
Clinical Research Associate
ClinWorld Pvt Limited/Sami-Sabinsa Group Limited
08.2017 - 11.2021
Rajiv Gandhi University of Health Sciences
Pharm.D (Doctor of Pharmacy) from Pharmacy
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