Summary
Overview
Work History
Education
Skills
Languages
Timeline
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Hasmita Patel

Montreal,QC

Summary

Over 20 years of experience in the CRO industry specializing in recruiting and retaining clinical trial participants for interventional and observational studies. Skilled in managing multiple clinical studies across sites and contributing to the planning and implementation of new clinical units for efficiency and quality standards. Excelled in Regulatory field by initiating study start-ups and maintaining audit readiness of Trial Master Files. Recognized for results-driven approach, strong communication skills, and dedication to achieving company objectives. Committed to continuous learning and professional growth.

Overview

24
24
years of professional experience

Work History

Clinical Documentation Specialist

MONTREAL HEALTH INNOVATIONS COORDINATING CENTER (MHICC)
01.2025 - Current
  • Assist the Project Manager with study start-up and site management activities.
  • For Study-start up activities, act as main contact for study sites during the start-up process and prepared study specific start-up document packages.
  • Collect, review and process all study start-up documents required to activate sites based on the established milestones.
  • Support sites with IRB submissions for both Central and Local IRBs.
  • Create and activate sites in CTMS and ensure to update all information during the course of the study.
  • Works closely with cross-functional teams to ensure timely submission and retrieval of essential documents from study start up to study close-out.
  • Performs regular reviews and quality checks of the TMF according to project-specific TMF plans for completeness, accuracy, timeliness, and consistency ensuring TMF inspection readiness.
  • Collaborates with team members to address any discrepancies or missing documents.
  • Educates and supports study team members and content owners on TMF-related responsibilities.
  • Oversees the proactive management of clinical documentation and trackers, ensuring that all documentation is up-to-date, compliant, and readily accessible.
  • Participates in process improvement of the TMF management, including the development and update of SOPs, guidelines, and training materials, as necessary.
  • Support TMF-related inspection and/or audit preparation and execution.
  • Provides status reports, trackers and metrics as requested (client meetings, presentations). Identifies eTMF trends and commonly misfiled documents.
  • Provides TMF training and support to the study team members.

Senior Clinical Trial Assistant (Sr.CTA)

EXACTIS INNOVATION
08.2021 - 12.2024
  • Assist the Project Manager with study start-up and site management activities.
  • Develop and maintain relationships with the study sites that will facilitate timely completion of start-up activities.
  • For Study-start up activities, act as main contact for study sites during the start-up process.
  • Collect, review and process all study start-up documents required to activate sites based on the established milestones.
  • Support sites with IRB submissions for both Central and Local IRBs.
  • Establish site activation timelines with other functional departments and selected sites to ensure alignment of activities to meet project timelines.
  • Track progress of start-up activities and keep detailed metrics.
  • Create and activate sites in the CTMS.
  • 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.
  • 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 - remote 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.
  • Assist in the preparation of internal and external regulatory inspections and tracking of action items.
  • Coordinates activities between the different departments and vendors involved in the project.
  • Assist the executive team with Request for Information (RFIs) and proposals and develop budgets with both internal and external stakeholders.

Weekend Physician Assistant and Medical Secretary

AGOO PEDIATRIC MEDICAL CLINIC
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, receive and communicate messages to medical staff and patients.
  • Help maintain the daily operations of the clinic on the weekends.
  • Establish and maintain records and confidential medical records.
  • Medical Billing.

Project Manager

VANTAGE
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 databases and systems.
  • In conjunction with management, assists with developing, documenting and updating internal processes and processes required for consistency 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 Trial and Quality Administrator

EXACTIS INNOVATION
04.2016 - 08.2020
  • Set-Up and maintain filing systems (ie; TMF and electronic filing systems).
  • 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
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.

Clinical Planning Manager

INVENTIV HEALTH CLINICAL
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.
  • Ensure 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

INVENTIV HEALTH CLINICAL
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 & Screening Coordinator

INVENTIV HEALTH CLINICAL
02.2002 - 05.2003
  • 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.

Education

College Degree - Social Science

Dawson College
01.1996

Bachelor - Biochemistry

Concordia University
01.1999

Skills

  • Documentation compliance
  • Process improvements
  • Clinical documentation management
  • Training and mentoring
  • Teamwork and collaboration

Languages

French
Professional Working
English
Professional Working

Timeline

Clinical Documentation Specialist

MONTREAL HEALTH INNOVATIONS COORDINATING CENTER (MHICC)
01.2025 - Current

Senior Clinical Trial Assistant (Sr.CTA)

EXACTIS INNOVATION
08.2021 - 12.2024

Project Manager

VANTAGE
08.2020 - 08.2021

Clinical Trial and Quality Administrator

EXACTIS INNOVATION
04.2016 - 08.2020

Clinical Trial Assistance

QUINTILES
10.2015 - 04.2016

Weekend Physician Assistant and Medical Secretary

AGOO PEDIATRIC MEDICAL CLINIC
09.2015 - 12.2023

Clinical Planning Manager

INVENTIV HEALTH CLINICAL
04.2007 - 07.2015

Recruitment, Screening and Marketing Manager

INVENTIV HEALTH CLINICAL
05.2003 - 04.2007

Recruitment & Screening Coordinator

INVENTIV HEALTH CLINICAL
02.2002 - 05.2003

Bachelor - Biochemistry

Concordia University

College Degree - Social Science

Dawson College

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Hasmita Patel