Hasmita Patel
Montreal,Canada
Summary
Over 20 years experience in the CRO industry. Over the years I gained valuable expertise in the recruitment and retention of clinical trial participants in both interventional and observational studies. I have gained valuable experience in the planning and management of multiple clinical studies over multiple sites. I have had the opportunity to participate in the planning of new clinical units, assessing and implementing efficiencies, ensuring timeframes and targets are met, that quality, customer satisfaction and costs are maintained and that internal and external expectations are optimally managed. I am Results-driven with a solid track record in delivering quality work. Known for excellent communication and teamwork abilities, with a commitment to achieving company goals and delivering exceptional service. Passionate about continuous learning and professional development.
Overview
25
25
years of professional experience
Work History
SENIOR CLINICAL TRIAL ASSISTANT
Exactis Innovation
Montreal, Canada
08.2021 - Current
- Assist the Project Manager with site management activities, and communicate with sites to ensure compliance with protocol requirements, study procedures, and relevant guidelines.
- Ensure study specific documents and project deliverables (e.g., protocol, ICFs, study documents, plans) meet applicable requirements.
- Collaborate with other functional departments to ensure alignment of activities to meet project timelines
- Work with sites to ensure compliance with the protocol, study procedures, guidelines and adhering to established milestones.
- Study Start-Up & Activation
- Prepare and submit Clinical Trial Applications, amendments, ongoing reporting and end of trial notifications to regulatory authorities
- Work with sites to ensure compliance with the protocol, study procedures, guidelines and adhering to established milestones.
- Assist Project Managers and Clinical Research Associates with the creation and maintenance of tracking tools and study materials
- Arrange and participate in the organization of Investigator and study team meetings
- Assemble and ship the Investigator Site File and supplies to investigative sites
- Manage and oversee the work and responsibilities of the CTAs, overseeing day to-day operations and ensuring high-quality service delivery in line with regulatory requirements, industry best practices and company procedures
- Quality control checks for TMF, identifying and resolving discrepancies
- Track site qualification, initiation, routine and close-out visits, project-specific training, monitoring visit reports and follow-up letters, compliance with monitoring plan, escalation of site-related issues.
- Support clinical trial monitoring activities on site or through central monitoring,
- Assist the Data Manager in CRF designs and reviews, central monitoring and queries resolution
- Participate in the development and/or review of SOPs, supporting documents, policies and work instructions
- Maintain documents for non-conformance, CAPA's and audit observations
- Assist in the preparation of internal and eternal regulatory inspections and tracking of action items
- Coordinates activities between the different departments and vendors involved in the project.
- Assist the executive team with RFIs and proposals
- Develop budgets with both internal and external stakeholders.
- Prepared submissions for Institutional Review Board or Ethics Committee approval, amendments, renewals.
- Generated reports summarizing patient safety information collected during a clinical trial.
- Coordinated shipment of study materials between sponsors, investigators, vendors.
PHYSICIAN ASSISTANT AND MEDICAL SECRETARY
Agoo Pediatric Medical Clinic
Montreal, Canada
09.2015 - 12.2023
- Helping doctors document medical visits and patient histories
- Weighing and measuring patients
- Working closely with pediatric generalists and specialists
- Schedule and confirm appointments with the doctor and receive and communicate messages to medical staff and patients
- Help maintain the daily operations of the clinic
- Establish and maintain records and confidential medical records
- Billing
CLINICAL PROJECT MANAGER
Vantage BioTrials Inc.
Montreal, Canada
08.2020 - 08.2021
- Manage the planning, execution, progress and completion of assigned clinical research projects
- Act as primary contact for client/sponsor
- Manage project contractual deliverables, including progress via metric and adherence to contractual agreement time, quality/scope, and cost deliverables
- Participate in qualified vendor selection and manage vendor activities
- Work with functional experts/vendors to ensure all project activities comply with applicable regulations, guidelines and corporate policies
- Develop and/or oversee development of study plans such as project management (including communication), monitoring, risk management, data management and safety plans
- Identify, assign and monitor the completion of interdisciplinary project tasks that include site monitoring, CRF and database development and revision, data collection, patient safety/adverse event management and document management
- Ensure studies are conducted in compliance with GCP, relevant SOP's and regulatory requirements
- Responsible for quality and completeness of TMF for assigned projects
- Ensure maintenance of study information on a variety of database and systems
- In conjunction with management, assists with developing, documenting and updating internal processes and processes required for consistence across programs such as SOPs, working practices and related quality assurance documents
- Participate in Business Development Activities
- Provide support in the review and development of proposal budget quotes and strategy
CLINICAL TRIALS AND QUALITY ADMINISTRATOR
Exactis Innovation
Montreal, Canada
04.2016 - 08.2020
- Set-Up and maintains filing systems (ie;Trial Master File and electronic filing systems)
- Site Start-up and Activation
- Ethics Submissions
- Prepare, distribute, track and file essential clinical trial documentation
- Assist Project Managers and Clinical Research Associates with the creation and maintenance of tracking tools and study materials
- Arrange and participate in the organization of Investigator and study team meetings
- Assemble and ship the Investigator Site File to Investigative Sites
- Prepare Health Canada Submission Packages [CTA/CTA-A/Notifications]
- Participate in the development and/or review of SOPs, supporting documents, policies and work instructions
- Develop, modify and utilize tools to track compliance issues and audit findings
CLINICAL TRIAL ASSISTANCE
Quintiles
Montreal, Canada
10.2015 - 04.2016
- Assisted Clinical Trial Research Specialist (CRS)/In-House Clinical Research Specialist (iCRS), Clinical Research Associates (CRAs)/In House Clinical Research Associate (iCRA) and Regulatory and Start-Up (RSU) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines
- Assisted the clinical team in the preparation, handling, distribution, filing and archiving of clinical documentation and reports according to the scope of work and standard operating procedures
- Ethics Submissions to Central REBs
CLINICAL PLANNING MANAGER
lnVentiv Health Clinical
Montreal, Canada
04.2007 - 07.2015
- Managed, evaluated, planned and scheduled clinical trials and major sponsor milestones according to participant recruitment capabilities, clinical bed, equipment and staff capacity
- Reviewed and participated in developing study protocols
- Tracked all project progress according to project plan and identified metrics
- Monitored and reported on the status of projects and barriers encountered
- Made recommendations to the Department Head regarding project scope and related changes required to facilitate a successful outcome
- Contributes to the implementation of effective processes to assess project risks, identify risk mitigation strategies and monitor risk throughout the project
- Implement framework for evaluating and monitoring outcomes for projects and developed and maintained accompanying documentation for internal and external use
- Ensures that revenues within the Clinical Division were reached by adhering to objectives that are pre-established by the company
- Assisted in the preparation of clinical project budgets
- Prepared financial indicators
- Ensured reliable, responsive and timely resolution of problems concerning clinical projects
- Supported and participated in different departmental efforts to improve clinical quality efficiency and cost control
RECRUITMENT, SCREENING AND MARKETING MANAGER
lnVentiv Health Clinical
Montreal, Canada
05.2003 - 04.2007
- Developed strategic recruitment plans and implemented outlined recruitment initiatives
- Managed multi-site call centers and screening centers
- Monitored the effectiveness of recruitment strategies
- Provided monthly reports for the executive team on the overall performance and effectiveness of the departments
- Development and maintenance of patient database
- Developed and maintained effective working relationships with staff, patients, physicians, external clinics and labs
RECRUITMENT AND SCREENING COORDINATOR
lnVentiv Health Clinical
Montreal, Canada
04.2000 - 05.2003
- Supervised all screening and subject/patient recruitment activities for each clinical project
- Direct supervision of employees in all activities related to the clinical protocol and SOPs
- Communicated the corporate and individual objectives to employees and ensured they were met
- Reported and analyzed department performances and results on a regular basis
Education
Biochemistry - 60 Credits
Concordia University
05.2000
DEC Social Sciences -
Dawson College
Montreal, QC05.1997
Skills
- Training and mentoring
- Good clinical practice
- Regulatory & Ethics Submissions
- Site Start-Up and Activations
- Monitor
- Trial Master File
- Standard Operating Procedures
- Study coordination
- Good Documentation Practice
- Data Management
- Project Management
- Quality Management
- Real-World Data & Real-world experience
- Patient registries
Therapeuticexperience
- Dermatology
- Infectious Disease
- Oncology
- Neurology
Timeline
SENIOR CLINICAL TRIAL ASSISTANT
Exactis Innovation
08.2021 - Current
CLINICAL PROJECT MANAGER
Vantage BioTrials Inc.
08.2020 - 08.2021
CLINICAL TRIALS AND QUALITY ADMINISTRATOR
Exactis Innovation
04.2016 - 08.2020
CLINICAL TRIAL ASSISTANCE
Quintiles
10.2015 - 04.2016
PHYSICIAN ASSISTANT AND MEDICAL SECRETARY
Agoo Pediatric Medical Clinic
09.2015 - 12.2023
CLINICAL PLANNING MANAGER
lnVentiv Health Clinical
04.2007 - 07.2015
RECRUITMENT, SCREENING AND MARKETING MANAGER
lnVentiv Health Clinical
05.2003 - 04.2007
RECRUITMENT AND SCREENING COORDINATOR
lnVentiv Health Clinical
04.2000 - 05.2003
Biochemistry - 60 Credits
Concordia University
DEC Social Sciences -
Dawson College
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