Clinical Project Associate

• Jun 2021 - Present

- Collecting regulatory and other essential documents from the clinical trial sites - Preparing and reviewing ethics submissions on behalf of clinical trial sites- Conducting Site Initiation Visits and Close Out Visits- Responsible for quality and completeness of TMF, study binder design and creation, source document design- Assisting CRAs - Monitoring BA/BE studies - Liaising with the study site, including physicians, study coordinators, in-patient nurses, regulatory personnel and other members of the site management team- Preparing Newsletter for the studies - Data monitoring - reviewing and evaluating data - Assisting in the Feasibility Process by preparing questionnaires based on protocol - Distributing FQs to sites and following up with completion assessments- Assisting Managing Director and Project Manager for new and ongoing clinical trials Show less

Clinical Project Assistant

• Mar 2021 - Jun 2021

Project Coordinator

• Oct 2018 - Jun 2021

Managing multiple projects at AC Tesla, a leader in an electrical system engineering and testing and emergency electrical distribution equipment specialist. - Oversight, maintenance and management of the project files and tracking systems. Perform general office support and administrative tasks, develop an automated invoice filing system that improved efficiency. - Create weekly progress and financial reports, frequently liaising with senior project stakeholders to keep them updated on the project progression. - Review of payments to vendors and management of invoices; analyze and resolve any payment discrepancies. - Responsible for approval and shipping of equipment and products, and regulatory documents to customers - Knowledge of regulatory requirements for customer compliance Show less

Clinical Research Assistant

• Apr 2018 - Aug 2018

Recruited and managed study participants, prepared and submitted REB submissions, and collected and entered data for the first Canadian hospital to achieve an Order of Excellence in Mental Health at Work from Excellence Canada. - Responsible for informed consent procedures with 25+ study participants - Reviewed subject inclusion and exclusion criteria, assessed patient vitals, performed a review of the patient's medical history and current symptoms, organized randomization procedures and blinding conditions. - Coordinated all clinical activities throughout each stage of the project: recruitment, screening, and study planning. - Entered subject study information into electronic data capture, including RAVE and Inform. - Prepared, reviewed, and maintained study-specific documents including Source Documents, site informed consent forms and Case Report Forms. Participated in the development, review, and implementation of site-specific SOPs. - Executed administrative aspects of the study including communication with the Research Ethics Boards, Sponsors, and Health Canada - Regulatory document preparation including amendments, annual REB/IRB renewals, protocol deviation submission as applicable, informed consent, and investigator study files, all in accordance with ICH/GCP guidelines - People choice award winner – “Retraining the brain – Neurofeedback for Childhood disorders.” Show less

Product Development Manager

• Dec 2009 - Jun 2012

Researched and developed a new animal nutrition line, managing the production coordinators, conducting testing, and planning a marketing strategy. - Planned, scheduled, and prepared farm animal meals, ensuring adherence to trial protocol and budget. - Analyzed 50 research study results and created 15+ reports critical to the trial outcomes. - Established the animal food production site, evaluating the facility for efficiency and costing. Researched and developed a new animal nutrition line, managing the production coordinators, conducting testing, and planning a marketing strategy. - Planned, scheduled, and prepared farm animal meals, ensuring adherence to trial protocol and budget. - Analyzed 50 research study results and created 15+ reports critical to the trial outcomes. - Established the animal food production site, evaluating the facility for efficiency and costing.