Open To Work
Kinjalben Patel
Scarborough,Canada
Summary
Passionate and organized learning and development professional and life long learner with 5 years of experience in adaptive skills, technical skills and leadership development training and development program. Specialized in trusted cross-departmental relationships and using important organizational context to assess and develop meaningful for staff and managers.
Overview
13
13
years of professional experience
Work History
Training and LMS Specialist
Teva Pharmaceutical
Scarborough, Canada
01.2019 - Current
- LMS Management: Design, develop and implement training programs/materials by working with the internal SMEs/external resources
- Incorporate experimental learning into the design of courses to ensure a practical “hands-on” style of training
- Program design includes: Instructor-led, online/e-learning methods
- Create new hire accounts and maintain employee-training records/accounts
- Manage all course deployments (creating/testing/assigning) and manage deployment logs
- Provide technical support to end users and perform troubleshooting activities
- Maintain LMS data integrity
- Perform system testing, as required and system upgrades
- Enter training records, as per training roster and update LMS as per approved LMS form(s)
- Provide compliance reports to Site Management, (monthly, pre-audit, audit, ad-hoc, etc.)
- Conduct learning group reviews with department Manager/designate
- Schedule new hire on-boarding, liaising with the hiring Manager/designate & conduct LMS/EDMS demonstration
- Manage the GMP signature form process, (as applicable)
- Prepare on-boarding package, as applicable & manage new hire list
- Schedule training, liaising with the department Manager/designate, as required
- Schedule and communicate site training for all shifts
- Maintain Training Team calendar and manage Technical Training mailbox
- Coordinate training logistics, i.e
- Equipment, rooms, resources, etc
- And manage training rosters (LMS entry/retention)
- Support Inspection Readiness program (running reports, training records/binders, communications, etc.)
- Support Training Consultant and Technical Training Specialist with site training programs and initiatives (contests, activities, communications, training, etc.)
- Manage On-the-Job Training (OJT) Program; (application and qualification forms, tracking log, LMS activities, scheduling, etc.)
- Creating SQL Server Reports using SSRS for inspection readiness
- Tasks included defining requirements, design, develop, test, implement and maintain reports using SSRS reports
- Documented the data such as attributes, file descriptions and definitions
- Participated in developing logic model and implementing requirements on SQL server.
Research Assistant (Volunteer)
iCORE at Sunnybrook Hospital
Canada
01.2021 - 01.2022
- Reviewing and adhering to the guidelines in the study protocol and operations manual
- Following study procedure and institutional guidelines to ensure privacy and confidentiality of data
- Collecting data on eligible patients’ ICU stay (ie
- Their admitting diagnosis, administered medications, vital signs, delirium assessments, mechanical ventilation settings, etc.)
- Entering data into databases such as Medidata RAVE, RedCap Cloud, and/or RedCap Academic
- Monitoring eligibility of patients in the critical care unit for eligibility from the time of admission to discharge
- Maintaining and updating the subject enrollment log
- Resolving study-specific data queries raised by site staff
- Maintaining secure storage of confidential documents with appropriate backup.
Clinical Research Coordinator
Muljibhai Patel Urological Hospital
India
01.2017 - 01.2018
- Participated in the coordination of protocol review and approval through to activation, follow up and trial closure
- Monitored and promoted the quality and integrity of data, recording clinical trial in case report forms (CRFs), and compilation of ethics and regulatory documents
- Interpreted the applicable regulations in order to ensure compliance and obtained high quality of data
- Participated in preparation and control of research budgets and financial payments manually to track budgets coming from sponsor
- Coordinated and performed data validation, clinical monitoring and study-related meetings
- Ensured conduct of research in accordance with ICH/GCP guidelines and applicable regulations
- Managed necessary records of study related activity which includes case report forms (CRF), drug dispensation records by entering study data into the applicable database for research purposes access
- Attended meetings and seminars to update knowledge of clinical research and related issues
- Enrolled and randomized subjects in the study as per the study protocol by checking medical records; directed the request, collection, labelling, storage, or shipment of samples and communicated with laboratories or researchers about laboratory findings
- Monitored enrolment status of participants and recorded dropout details including causes and subject contact efforts for future communication
- Recorded adverse event and side effect information and consulted with investigators concerning the reporting of events to regulatory agencies for appropriate action
- Prepared trial-related paperwork such as protocol worksheets, adverse event reports, Institution Review Board documents, procedural manuals and progress reports to ensure the progress of the trial
- Managed subject registration to make sure that informed consent is effectively obtained and recorded
- Dispensed study medical devices or drugs to subjects, determined dosages and delivered instructions as necessary to record safety and efficacy of the drug
- Prepared packages for distribution as per the regulations for the packaging and transport of Nuclear Substances, and International Air Transport Association.
Senior Associate (e-TMF Specialist)
Syntel Ltd.
India
01.2013 - 01.2016
- Identified, named, and categorized all clinical and regulatory documents for easy access
- Conducted 100% quality check of the entire documents to be able to rectify the error before submitting the documents
- Adhered to company and process policies at any given point of time for smooth conduct of the project
- Attributed mapping of the document, Trial Master File entry, quality check of own document before submitting to reduce the work of the quality analyst team
- Updated master inventory sheet, quality check report and submitted work in timely manner to track the proper records of the documents
- Allocated work to team members, resolved queries when needed, had update sessions and meetings which resulted into completion of work before timeline.
Education
Oxford College (Clinical Research) -
01.2022
Master of Science (Clinical Research) -
01.2010
Bachelor of Science (Biotechnology) -
01.2008
Skills
- Root Cause Analysis
- Emergency Response
- Customer Relations
- Quality Assurance
- Proficient in Microsoft 365, articulate 360, captivate module
- Attention to Detail
Tel
(204) 930-7098
Training
- ICH-GCP E6(R2) Guidelines, 2021
- TCPS 2, 2021
Work Preference
Job Search Status
Open to workLocation Preference
On-SiteRemoteHybridSalary Range
$45000/yr - $200000/yrTimeline
Research Assistant (Volunteer)
iCORE at Sunnybrook Hospital
01.2021 - 01.2022
Training and LMS Specialist
Teva Pharmaceutical
01.2019 - Current
Clinical Research Coordinator
Muljibhai Patel Urological Hospital
01.2017 - 01.2018
Senior Associate (e-TMF Specialist)
Syntel Ltd.
01.2013 - 01.2016