Shannon Raked
Vancouver
Summary
Accomplished Clinical Research Associate with 5 years of experience in pre-study site evaluations, regulatory document collection, interim monitoring, and study close-out visits. Conducts studies aligned with good clinical practices, study-specific requirements, and clinical risk-based monitoring plans. Skilled in training site staff and new CRAs, negotiating study budgets, and ensuring adherence to SOPs. Proficient in MS Office, electronic data management systems, and adapting to new software tools. Possesses in-depth knowledge of company procedures, regulatory requirements, and quality standards. Demonstrates flexibility, adaptability, and willingness to relocate and travel as required for the role.
Overview
6
6
years of professional experience
Work History
Clinical Research Associate II
Biolytical Laboratories
01.2024 - 06.2024
- Performance of independent onsite monitoring visits for Clinical Trials
- Managing multiple clinical study trials/protocols
- Demonstrating and integrating bioLytical products knowledge to design, create, and write trial protocols and study documentation, including ethics applications and liaison with regulatory authorities
- Leading the identification, evaluation, and establishment of trial sites
- Negotiation of site budgets and agreements
- Steering meetings with contract research organization (CRO) and sites around clinical activities
- Training and overseeing site staff on investigational products, therapeutic areas, protocol requirements, proper source documentation, and case report form completion
- Leading the ethics committee approval process regarding the rights, safety, and well-being of trial subjects
- Facilitating comprehensive Regulatory Submissions to Health Canada, FDA, TGA and EU
- Managing clinical trial materials, including verification of Investigational Product (IP) dispense
- Overseeing study database design and management
- Ensuring compliance with SOPs, local regulations, and ICH-GCP guidelines
- System Operations/Databases: MS Office (Advanced Word, Excel and PPT), Adobe Acrobat, ShareFile, Syspro, DistillerSR, REDCAP, WebView, ePro, WebView, ePro, PRS on Clinicaltrial.gov, QC for Salesforce
In-house Clinical Research Associate
Biolytical Laboratories
01.2022 - 01.2024
- Performance of independent remote site monitoring across Canada and the United States (US) to ensure adherence to ICH-GCP and regulatory requirements
- Management of data collection and tracked subject recruitment plans
- Managing major clinical study trials
- Source review and verification for data accuracy
- Upholding the integrity of site practices and collected data
- Leading the ethics committee approval process, ensuring trial subjects’ rights, safety, and well-being
- Coordination of project meetings to facilitate efficient workflow
- Development of Case Report Forms (CRF) and conducted data monitoring
- Conduct literature reviews and contributions to study protocol development, data analysis, and end-of-study reports
- Providing direct data and/or clinical research support under direct supervision for clinical trials, studies, and general research
- Development of Clinical Standard Operational Procedures (SOP) to streamline processes
- Preparation of Clinical Performance Evaluation, Scientific Validity, Performance Evaluation Reports, and Post-marketing surveillance documents in accordance with EU IVDR
- Acting as an Internal Auditor in compliance with MDSAP: ISO13485:2016, IVDD/IVDR standards
- Providing auxiliary Quality Assurance (QA) support for document review and batch release
- System Operations/Databases: MS Office (Advanced Word, Excel and PPT), Adobe Acrobat, ShareFile, Syspro, DistillerSR, REDCAP, WebView, ePro, WebView, ePro, PRS on Clinicaltrial.gov, QC for Salesforce
Clinical Research Coordinator
Medical Arts Health Research Group
11.2019 - 12.2021
- Execution of site recruitment plan, screening, and participant enrollment
- Informed Consent Form (ICF) process
- IRB/REB submissions (Advarra, WCG Connexus, Veritas Concierge)
- Completion of regulatory documents
- Serious Adverse Event (SAE) and Temperature Excursion (TE) reports
- Study protocol implementation and team training
- Addressing queries reviewing of monitoring reports
- Keeping Investigator Site File (ISF) and patient document sources updated
- ICH-GCP compliant
- Handling and processing Biological samples
- Clinical studies of Central Nervous System (CNS) and Gastrointestina (GI)
- System Operations/Databases: Interactive Web Response Systems (IWRS) registration, Electronic Data Capture (EDC), InForm and iMedidata RAVE eCRFs, Clinical Trial Management Systems (CTMS)
Laboratory Assistant
Skin Care Surgery Centre
05.2018 - 11.2019
- Assisting with the preparation of horizontal frozen histologic section to a standard acceptable to the physicians and VHC dermato-pathologist
- Responsible for accessioning, fixing, staining, cover slipping tissues
- Maintaining a clean, efficient, and safe working area
- Keeping accurate logs of the processed Mohs suspected cancerous specimens
Clinical Research Coordinator
Digestive Health Clinic
05.2019 - 07.2019
- Recruitment management, screening, and participant enrollment
- Subject pre-screening by carrying study specific tests (e.g., UBT Test)
- Informed Consent Form process
- Study protocol implementation, data collection and maintenance of study progress up-to-date
- Study drug dispensation and re-collection
- Experienced mainly in Gastrointestinal (GI)
- Databases: Interactive Web Response Systems (IWRS) registration, Electronic Data Capture (EDC), iMedidata RAVE eCRF
Education
Masters of Regulatory Affairs - undefined
Northeastern University
Boston, MA04.2023
Post-Graduate Certificate - Clinical Research
Humber College
Toronto, ON08.2019
Bachelor of Science - Biology
Kwantlen Polytechnic University (KPU)
Surrey, BC04.2018
Skills
- Site management
- Pharmacovigilance
- Detailed documentation
- Electronic data capture
- Project monitoring
- Clinical trial management
- Team Training
- Recruitment strategies
- Interdepartmental collaboration
- IRB submissions
Languages
English Fluent
English
Native or Bilingual
French
Elementary
Persian
Native or Bilingual
Accomplishments
- IVDD/98/79/EC certification
- MDSAP and ISO13485:2016 Training certification
- Clinical Research Associate Certification—VIARES/IQVIA Biotech.
- Good Clinical Practice (GCP) Certification
- WorkSafe BC WHMIS Certification
- Laboratory Safety Regulations and MSDS Certification
- Tri-Council Policy Statement (TCPS 2: Core) Certification
- Achieved compliance to required regulations through effectively helping with internal audits.
- Collaborated with scientific and regulatory teams in the development of SOPs.
Timeline
Clinical Research Associate II
Biolytical Laboratories
01.2024 - 06.2024
In-house Clinical Research Associate
Biolytical Laboratories
01.2022 - 01.2024
Clinical Research Coordinator
Medical Arts Health Research Group
11.2019 - 12.2021
Clinical Research Coordinator
Digestive Health Clinic
05.2019 - 07.2019
Laboratory Assistant
Skin Care Surgery Centre
05.2018 - 11.2019
Masters of Regulatory Affairs - undefined
Northeastern University
Post-Graduate Certificate - Clinical Research
Humber College
Bachelor of Science - Biology
Kwantlen Polytechnic University (KPU)
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