Prabina Neupane
Cupertino,USA
Summary
Highly motivated individual with a desire to take on new challenges. Strong work ethic, adaptability, organized and motivated employee eager to apply time management and organizational skills in various environments. Adept at working effectively unsupervised and quickly mastering new skills.
Overview
9
9
years of professional experience
Work History
Senior Centralized Study Specialist, Trip Report Reviewer
Labcorp Drug Development
India
08.2021 - 05.2022
- Roles and responsibilities include: Managing complex projects in collaboration with Project Manager and proactively identifying opportunities for process improvements
- Monitoring and ensuring that the site monitoring responsibility for clinical studies are conducted according to Labcorp Standard Operating Procedures, Work Instructions, ICH Guidelines and GCP, and with necessary training completion assigned as per the role within timelines
- Collaborating with project teams in implementation of best TRR practices and applicable project plans as assigned (implementation of initiatives either independently or with team) Ensuring issues-follow-up, risks, protocol deviations and Labcorp Corrective Action Issue Resolution (CAIR) and to liaison between CRA, CTL and PM for timely resolution of issues
- Liaise with CTL/PM to communicate any trends, outstanding issues, safety concerns or any other activity or lack thereof which may jeopardize the clinical trial delivery or patient safety
- Mentoring, training and providing quality checks of new TRRs on trip report review processes as per ICH-GCP and in house SOPs and local work instructions
- Review and support development of training material and plans to support the training requirements of the department
- Ensure training resources are kept up to date with changes in procedures
- Contribute to improvements to enhance the efficiency and quality of work on assigned projects.
Clinical System Specialist - 1, (Site Report Specialist + Central Monitoring Lead)
IQVIA
Bangalore, India
11.2017 - 08.2021
- Roles and responsibilities include: Review and approve the SVR across multiple clinical projects
- Assist primary study Clinical Lead (CL)/Clinical Project Managers (CPM) with the attainment of clinical deliverables within study timelines and budget by setting up clinical tools and processes for the study team
- Assist primary CL/CPM with study set-up and follow-up study activities through ongoing tracking and review of study progress
- Conduct with the CL/CPM frequent team meetings and ensure regular communication
- Contribute to the risk management plan from a clinical perspective and coordinate clinical issue escalation and resolution with the primary CL/CPM/CSMQM and/or line managers
- Identify quality issues within the study through regular review of the clinical team communications including site communications, monitoring visit reports, data flow information and quality assurance audit findings
- Collaborate with CL/CPM to define Visit annotations, Site Visit Report (SVR) guidelines and study tools (monitoring flow sheets and trackers) to assure efficient completion of SVRs by CRAs
- Work to decrease the level of corrections/additions needed on reports by mentoring CRAs on report writing per annotations
- Escalation of CRA report writing and SOP submission compliance issues to the CL/CPM and Line Manager Assisting Clinical Project Manager (CPM) and Clinical Team Lead (CTL) with site management activities such as updating Site monitoring visit, tracking of site visits, communication with CRAs, audit preparation and other activities as assigned
- Performing Vendor activities (provide Inform, RAVE, IWRS, Investigator Portal, Infosario, AgMednet etc
- Access to site staff, internal and external team members)
- Periodic eTMF/TMF review (Site level and Country level) of study documents
- Performing remote subject level data review
- Prepare and send an i-site pack to CRA prior to any monitoring visit
- Review payment batch on a regular basis and provide approval
- Provide training to the team member on site management activities.
Clinical Research Associate
Lambda Therapeutic Research
India
05.2016 - 06.2017
- Roles and responsibilities include: Perform Site Identification and conduct Feasibility Studies
- Perform Site Selection Visit, Site Initiation Visits in accordance with the protocol and other applicable regulatory guidelines including local regulatory guidelines
- Perform Site Monitoring Visit and Site Close-Out Visit in accordance with the protocol and other applicable regulatory guidelines including local regulatory guidelines
- Send Follow Up letters to sites and submit Visit Reports to the Clinical Team Leader/ Project Manager as required
- Keep a close association with site (s) for: Subject Recruitment, Subject Follow Up, and protocol related activities
- Act as a communication Link between Sponsor and the site
- Maintain accurate and timely sponsor/site correspondence and communication
- Prepare Ethics Committee Submission packages
- Preparation of Regulatory Binder
- CIF and SIF updation
- CRF retrieval as per the project instructions
- Coordinate and distribute Clinical Study Material to study sites
- BABE Monitoring (oversight).
Clinical Research Associate
Abott Medical (former St. Jude Medical)
Delhi, India
06.2013 - 06.2015
- Roles and responsibilities include: Clinical studies with intensive cardiovascular safety monitoring
- Manage the entire course of clinical study including clinical trial documents preparation and review, site feasibility, site and EC related communication and coordination with sites for EC submission, monitoring visit, preparation and maintenance of Sponsor Master file, Green light documents preparation, CRF review, maintenance and review of site payment batches and agreements, maintenance of internal SOP and training logs
- Identify and screened potential investigators and conduct pre-study site visits
- Coordinate with the site staff as well as data management team for the query resolution during the entire period of the study
- Review of protocol and ICF and providing operational inputs
- Maintain regular communication with designated sites, ensuring adequate information between
- Ensure that the investigators and site staff are aware of and comply with the study protocol, procedures and SOPs, GCP and other regulatory requirements
- Prepare and discuss site validation questionnaires with the potential investigators
- Conduct monitoring visits for sites in accordance with the agreed schedule
- Remote review of case record forms and coordinate with the site for resolution of data queries
- Adverse event evaluation and reporting within specified timelines
- Continuous literature reviews pertinent to assigned studies.
Education
Master of Science in Statistics - Statistics
Neuchatel University
Switzerland12.2023
Pharmaceutical Sciences
Rajiv Gandhi University of Health And Science
08.2012
Skills
Hard Skills
- Clinical Research: Onsite and Remote Monitoring
- Risk-Based Monitoring, Centralized Monitoring
- Trip Report Review
- Payment Specialist
- Regulatory Specialist
- Statistics, Data management, Data Analysis
- Programming Language: R-programming, Python and SAS
Soft Skills
- Time management
- Communication
- Adaptability
- Teamwork
- Leadership
- Honest
Skills
Advanced Regression Methods, Inferential Statistics and Test Theory, Multivariate Analysis, Nonparametric Statistics, Probability Theory, Survey Sampling, Computational Statistics, Design of Experiments (DoE), Statistical Learning, Bayesian Statistics, Time Series Analysis, R, SAS, Immune Mediated Inflammatory Disease: Systemic IMID: Rheumatoid Arthritis (Phase II), Cardiovascular: Tachycardia/Bradycardia (Phase III), Oncology: Solid Tumor: Breast (Phase II/Phase III), Lung Cancer (Phase II), Endocrine Metabolic: Ulcerative Colitis (Phase III), Ophthalmology: Age Macular Degeneration (Phase III), Dermatology: Atopic Dermatitis (Phase III), Androgenic Alopecia (Phase III), Neurological Disorder: Schizophrenia (Phase III), Device: Pacemakers/Stents - Cardiovascular, Infectious Disease: Anti-Viral Therapy - COVID Vaccine (Phase II)
Languages
- English
- Nepali
- Hindi
- French
Languages
English
Full Professional
French
Limited
Hindi
Professional
Nepali
Native/ Bilingual
Timeline
Senior Centralized Study Specialist, Trip Report Reviewer
Labcorp Drug Development
08.2021 - 05.2022
Clinical System Specialist - 1, (Site Report Specialist + Central Monitoring Lead)
IQVIA
11.2017 - 08.2021
Clinical Research Associate
Lambda Therapeutic Research
05.2016 - 06.2017
Clinical Research Associate
Abott Medical (former St. Jude Medical)
06.2013 - 06.2015
Master of Science in Statistics - Statistics
Neuchatel University
Pharmaceutical Sciences
Rajiv Gandhi University of Health And Science
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