SHARMIN SUMI
Saskatoon,Canada
Summary
Detail-oriented Clinical Research Professional with a strong background in project management and oversight. Experience includes managing clinical trials, ensuring compliance with ICH/GCP standards, and managing participant recruitment and data collection processes. Adept at maintaining accurate documentation, improving trial procedures, and enhancing data integrity. Recognized for strong organizational skills, and the ability to efficiently manage multiple priorities in fast-paced environments.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator Administrator
Clinical Trail Support Unit
Saskatoon, SK
01.2025 - Current
- Oversees the initiation, monitoring, and closure of assigned studies in accordance with ICH-GCP guidelines, and applicable local regulations.
- Coordinates site qualification visits, as well as the collection, preparation, review, and tracking of documents required for the application process.
- Actively participates in any study team meeting to initiate, monitor, and close study sites.
- Responsible for managing study supplies, including Investigator Site Files (ISF), investigational drug supplies, and drug accountability at the study site.
- Assists the site in maintaining and managing investigational site files.
- Maintained accurate documentation and data integrity throughout the study lifecycle.
- Actively conducting local and remote studies.
BUSINESS DEVELOPMENT ASSOCIATE
Independent Contract Position
Saskatoon, Canada
01.2023 - Current
- Work as an independent contractor (part-time) in start-up development in the domain of life sciences
- Contribute to business idea generation, business plan development, and project management
- Provide administrative support in the business licensing process and team development
Clinical Research Coordinator
Department Of Pediatrics, USASK
Saskatoon, Canada
01.2024 - 12.2024
- Manage the planning, execution, and progress of multiple projects in an interdisciplinary environment.
- Obtain informed consent processes for more than 60 prospective research participants.
- Gather, process, and ship lab specimens.
- Follow clinical research protocols, and demonstrate study visits in compliance with ICH/GCP, and FDA regulations.
- Organize patient data on a data management platform.
- Perform effective communication with all stakeholders to pursue the studies smoothly.
- Co-ordinate effectively with professionals, physicians, administrative staff, and patients to ensure smooth coordination.
- Analyze and collate information from an existing dataset.
- Contribute to several laboratory-based research activities.
- Perform literature reviews and manuscript writing.
- Reviewed medical information from source documents to verify the accuracy of CRF entries prior to database lock.
RESEARCH TECHNICIAN
Vaccine And Infectious Disease Organization
Saskatoon, Canada
09.2022 - 11.2022
- Contributed to several projects focused on molecular virology by performing various molecular biology and immunology techniques.
- Planned, designed, optimized, and executed experiments; collected, analyzed, and interpreted experimental data.
- Managed laboratory orders and inventory, developed laboratory protocols, and organized lab data to ensure smooth operations.
BIOLOGICAL TECHNOLOGIST
Quantum Genetix
Saskatoon, Canada
01.2019 - 03.2022
- Successfully led and managed several projects.
- Collaborated with healthcare professionals to collect clinical samples for COVID-19 testing, conducted the informed consent process for saliva sample collection, and handled COVID-19 test samples following Health Canada regulations.
- Performed and facilitated molecular diagnostics on COVID-19 test samples, and crop and livestock.
- Communicated frequently with clients and medical providers.
- Conducted detailed client intakes and entered information into the company database.
RESEARCH ASSISTANT
Cross Cancer Institute
Edmonton, Canada
01.2015 - 08.2016
- Coordinated and managed several projects with high integrity.
- Gathered in-depth drug discovery research experience in a multidisciplinary research environment, with high proficiency.
- Presented research findings at different national and international conferences and seminars, with high efficiency.
Education
Master of Science - Pharmacy
University of Saskatchewan
Saskatoon, SK10.2018
Skills
- Study monitoring
- Clinical trial management
- Working knowledge of ICH, GCP, and local guidelines
- Literature review and manuscript writing
- Microsoft Office software, including Outlook, Word, PowerPoint, Excel, and PDF software,
- Excellent interpersonal and communication skills
- Attention to detail
- Strong organizational, analytical, and problem-solving skills
- Project management
- Data management
- Regulatory compliance
Certification
- Association of Clinical Research Professional Certification- In progress
- Clinical Research Coordinators (CRC)- Canada (CITI PROGRAM)
- Canada GCP (CITI PROGRAM)
- Health Canada Division 5- Drugs for Clinical Trials Involving Human Subjects (CITI PROGRAM)
- Certificate in Clinical Research Operations for Study Coordinators (Global Health Training Center)
- Google Project Management
- Pharmaceutical Regulatory Affairs from Seneca College- In Progress
- Business and Management: Business Foundation Specialization, Laboratory Management and Quality Management, Good Laboratory Practice (GLP), Good Manufacturing Practices (GMP)
- Occupational health and Safety: Biosafety, Laboratory Safety, Workplace Hazardous Materials Information System, Transportation of Dangerous goods
Leadership And Volunteering Activities
- Vice President (Culture), Bangladesh Student Association of University of Saskatchewan, 2016-2017
- Volunteer, College of Pharmacy and Nutrition, University of Saskatchewan, Volunteer at departmental professional events
- Volunteer performer, Saskatoon Folkfest, International Mother Language Day celebration, cultural events organized by Bangladeshi Students and Community based Associations of Saskatchewan
Timeline
Clinical Research Coordinator Administrator
Clinical Trail Support Unit
01.2025 - Current
Clinical Research Coordinator
Department Of Pediatrics, USASK
01.2024 - 12.2024
BUSINESS DEVELOPMENT ASSOCIATE
Independent Contract Position
01.2023 - Current
RESEARCH TECHNICIAN
Vaccine And Infectious Disease Organization
09.2022 - 11.2022
BIOLOGICAL TECHNOLOGIST
Quantum Genetix
01.2019 - 03.2022
RESEARCH ASSISTANT
Cross Cancer Institute
01.2015 - 08.2016
Master of Science - Pharmacy
University of Saskatchewan
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