Xin Dong

Experience

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  Self Employed

  Jan 2016 - Apr 2022

  Physiotherapist

  Evaluate clients’ injuries through subjective interviews and objective assessments. Plan treatment according to the functional and physical limitations. Perform appropriate interventions. Follow up with clients’ progression.

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  McGill University

  Apr 2016 - Mar 2020

  Personal Trainer

  Evaluate clients’ strength, endurance and mobility. Design exercise programs according to clients’ goals and current conditions. Demonstrate and correct exercise techniques. Follow up with clients’ progression.

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  Epicentre Training

  Nov 2016 - May 2019

  Personal Trainer
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  Clinical Research Unit at The Neuro

  Apr 2017 - Apr 2022

  - Directly oversee the neuromuscular disease team of clinical research coordinators and interns. Lead onboarding of new staff and ensure GCP compliance.- Conduct interviews for coordinator applicants.- Conduct annual performance evaluations to reflect and improve personal and professional objectives. - Overseeing all active trials in rare neuromuscular disease. Collaborate with ethics, contract, and budget officers in Startup activities. - Lead Site Selection Visits. Complete regulatory documents and Feasibility Questionnaires. Review study budget and elements in CTMS.- Maintain clinical research coordinator duties. Show less - Perform key outcome measures for clinical trials such as walk tests, Myasthenia Gravis outcome measures, Muscle Manual Testing, Hand-Held Dynamometry, Motor Function Measures, Hammersmith Functional Motor Scale, Gross Motor Function Measure-88, Upper Limb Modules, Biodex strength testing, Reachable Work Space.- Train new clinical evaluators on outcome measures.- Develop training materials on outcome measures.- Consulted on outcome measure details by IIT team.- Organize and lead virtual training sessions on MMT and HHD for other study sites. Show less - Independently coordinate from site activation to close out (including phase II, III, investigator-initiated trials and observational trials) in the rare neuromuscular disease area (SMA, FSHD, MG, CIDP, Amyloidosis, and Post-Polio Syndrome). - Essential in managing the first FSHD and Amyloidosis drug trials in Québec.- Pre-screen and recruit patients. Highest Canadian site recruiter for 2 FSHD trials. Perform informed consent. Schedule and conduct visits according to protocol. - Prepare ethics submission (protocol/IB amendments, annual renewals, site close-out reports) to local REB for single-center and multicenter trials using Nagano Platform.- Prepare source documentation, complete data entry and resolve queries. Manage the Investigator Site File. Prepare for CRA monitoring visits and audits. Lead Site Initiation Visits and Site Close-Out Visits.- Organized and led patient focus groups to introduce clinical trials to patients and physicians. Show less

  • Senior Clinical Research Coordinator / Disease Lead

    Dec 2019 - Apr 2022

  • Clinical Outcome Evaluator

    Nov 2016 - Apr 2022

  • Clinical Research Coordinator

    Apr 2017 - Dec 2019
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  Self-employed

  May 2019 - Apr 2022

  Powerlifting Coach

  Virtually train multiple athletes to multiple provincial and national powerlifting records. Long-term planning and daily feedback with the athletes.

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  Merck Canada

  Apr 2022 - now

  Clinical Operations Manager

  − Executes and oversees clinical trial country submissions and approvals in Oncology and General Medicine Trials.− Develops local language materials including country and site Informed Consents and translations. Interacts with the Institutional Review Board/Institutional Review Committee and Regulatory Authority.− Subject Matter Expert for Informed Consents. Prepares and organizes trainings for Clinical Research employees. − Manages country deliverables, timelines and results to meet country commitments. Responsible for quality and compliance in country. − Coordinates and liaises with Clinical Research Manager, Clinical Trial Coordinator, Clinical Research Associate, Regulatory Affairs, Global Team, Finance and Legal to ensure country deliverables are obtained for submissions, budgets, Clinical Trial Research Agreements and local milestones. Partners closely with Headquarter to align country timelines for assigned protocols. − Oversees and coordinates local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical systems. − Ownership of local regulatory compliance. Significant impact on country-specific trial deliverable commitments and objectives during study start-up and maintenance. − Collaborates with site investigators/ staff− Contributes strongly to the Clinical Operations Manager’s/ Country Operations Manager’s team and other Country Operations roles knowledge by acting as an Informed Consent Representative, sharing best practices, making recommendations for continuous improvement and providing training. − Contributes to the Clinical Operations Manager team knowledge by acting as a mentor and sharing best practices. Show less

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  The PMCQ

  Sept 2024 - now

  Member Board of Directors

  Board Member on the Board of Directors on behalf of Merck Canada