Prakriti Neupane
Scarborough,ON
Summary
Knowledgeable Clinical Research Associate with several years of experience in documenting and assisting in clinical trials research. Clear, concise and effective written communication abilities. Thorough knowledge of FDA and GCP principles and regulations. Committed to providing support to the project team and executing responsibilities as instructed.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Clinical Research Associate
JSS Medical Research
Kollam, Kerala
02.2022 - 05.2023
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
- Provided clinicians with data to conduct clinical trials and determine methods to prevent, screen for, diagnose and treat disease.
- Followed drug storage procedures to comply with protocols and SOP requirements.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Budget preparation and negotiation
- Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
- Liaised with clinical project leader to effectively resolve study-related issues.
- Gathered and organized clinical trial documentation to meet rigorous standards for site approval.
- Established drug trial methodologies and procedures to support business and clinical trial endeavors.
- Mentored team members by sharing suggestions and encouraging ideas to deliver successful studies.
- Conducted clinical trial in accordance with protocol and recorded and monitored progress.
- Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
- Set up and disbanded trial study centers to manage clinical study activities for more than 25 sites.
- Actively being trained and training the team on risk based monitoring and its significance.
Clinical Research Associate
Sami-Sabinsa Group Limited
Bangalore, Karnataka
08.2017 - 11.2021
- Performed pre-study site evaluations, site initiations, interim monitoring and study close-out visits while collecting regulatory documentation.
- Worked alongside senior team members to learn related job tasks and roles.
- Attended training sessions and meetings to learn new information and develop personal skills.
- Developed essential skills and techniques through diligent practice.
- Delivered materials and documentation promptly to project managers and employees.
- Reported to project manager for issues related to overall study status.
- Maintained accurate records of all regulatory submissions, correspondence and approvals received from local ethics committees or regulatory agencies.
- Evaluated proof of eligibility and consent for participants.
- Developed protocols and case report forms to standardize operations.
- Assisted in medical writing like protocol, Investigator's Brochure, Case Report Form, Informed consent, clinical study report and manuscript.
Education
Doctor of Pharmacy - Pharmaceutical Sciences
Rajiv Gandhi University of Health Sciences
Bangalore, Karnataka, India06.2017
Skills
- Detailed Documentation
- Trip Reports
- Research and Development
- Investigator Meetings
- Data Collection
- Office Operations
- Patient Recruitment
- Site Visits
- Monitoring Plans
- Site Management
- Statistical analysis
- Clinical Trials and Research
- Good Clinical Practice
- Microsoft PowerPoint
- Digital Filing
- Data entry
- Team Monitoring
- ICH
- Patient Safety
- Regulatory Requirements
- Scheduling Proficiency
Certification
ICH-GCP April 2023
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
soft skills
● Interpersonal skills ● Self-motivated ● Hard working ● Communication ● Leadership ● Empathy ● Multitasking
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 Cosmeceutical
Timeline
Clinical Research Associate
JSS Medical Research
02.2022 - 05.2023
Clinical Research Associate
Sami-Sabinsa Group Limited
08.2017 - 11.2021
Doctor of Pharmacy - Pharmaceutical Sciences
Rajiv Gandhi University of Health Sciences
Similar Profiles
Mohammed Vikhar AhmedMohammed Vikhar Ahmed
Clinical Research Associate- Assistant Manager Grade at JSS Medical Research Asia PacificClinical Research Associate- Assistant Manager Grade at JSS Medical Research Asia Pacific
Zahra FaridZahra Farid
Clinical Data Manager at JSS Medical ResearchClinical Data Manager at JSS Medical Research
Dr Shakthibala R RDr Shakthibala R R
Senior Clinical Research Associate at JSS Medical Research Asia pacific Pvt ltdSenior Clinical Research Associate at JSS Medical Research Asia pacific Pvt ltd
Joydeep ChakrabortyJoydeep Chakraborty
Clinical Research Coordinator at JSS Medical Research Pvt. LtdClinical Research Coordinator at JSS Medical Research Pvt. Ltd
Samanpreet KaurSamanpreet Kaur
Contact Center Representative & Insurance Sales Advisor at TD InsuranceContact Center Representative & Insurance Sales Advisor at TD Insurance