Clinical Research Lead

Responsibilities:Coordinate the day-to-day operation within the Clinical Research team; plan and manage personnel and resource requirements.Conduct and document study monitoring/site visits, coordinating project meetings and implementing actions for sites do not meeting expectations.Guide the development of and provide oversight to clinical research project timelines.Ensure compliance with SOPs and local regulations, and ICH and GCP guidelines.Identify, evaluate, establish, and close trial sites, negotiate site budgets and agreement.Train and oversee site staff on product tests, therapeutic areas, protocol requirements, proper source documentation, and case report form completion.Liaise with the ethics committee regarding the rights, safety, and well-being of trial subjects.Oversee study database design and management.Order, track, and manage clinical and trial materials.Oversee and document investigational product dispensing inventory, and reconciliation.Protect subjects’ confidentiality, update information, and verify IP have been dispensed and administered according to protocol. Qualifications: Bachelor’s degree in Biological Science or a related field.Minimum 5 years of experience as a Clinical Research Associate.Strong background in statistical data collection, validation, editing and analysis techniques.Knowledge of the diagnostics industry, terminology, and practices and FDA regulations and their practical implementation.Superior problem solving, deductive reasoning and decision-making skills.Good time management and ability to prioritize tasks and accomplish set goals efficiently.Strong verbal and written communication skills.Proficient computer skills, with Microsoft Office Word, Excel, and PowerPoint.Experience liaising with Regulatory Authorities i.e. US FDA, Health Canada, Notified Bodies will be an asset.Knowledge of Canadian, US and European regulations, ISO 13485 and ISO 14971 will be an asset.