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Job #02732

About our client Our client is a world leading healthcare company that has developed a reputation for successfully bringing impacting products to market. The company has an experienced management team, a robust pipeline, and an empowering corporate culture that is focused on the professional development of its employees. Position Location Clinical Research Associate/Project Manager Manitoba Salary Highly competitive package, commensurate with experience Responsibilities 1) Coordinate clinical trials and assist Study Team in planning, evaluating, implementing, monitoring, and managing clinical studies in adherence to applicable regulatory requirements to meet overall project objectives 2) Manage investigative sites and perform site evaluation, selection, and start-up activities 3) Initiate routine on-site monitoring and closeout visits 4) Communicate (regularly) to collect accurate and complete clinical data, verify source documents, and collect study documents 5) Initiate communication to ensure compliance with study protocol, and client corporation’s SOPs, GCP guidelines, and regulatory requirements 6) Prepare site agreements and contracts along with performing financial tracking during study conduct  7) Assist the Clinical Study Team with the development of clinical protocols, Case Report Forms (CRFs), and clinical study reports 8) Develop Informed Consent Forms (ICFs), study documents and study management tools 9) Coordinate investigator and study meetings including preparation and presentation of information 10) Train investigative site staff on protocol, study conduct, GCP guidelines, and regulatory requirements 11) Document clinical trial progress to ensure completeness of documentation and data collection, management of supplies and resources in adherence with the project timelines, budgets, and quality standards 12) Manage external contracts and resources, including central laboratory and contract research organizations 13) Interact with internal groups including Clinical Science, Data Management, Pharmacovigilance, Shipping/Logistics, Regulatory Affairs, Quality Assurance, and Business Development during clinical study lifecycle Requirements 1) Degree in Life/Medical Sciences (Nursing, Pharmacy or relevant basic sciences) 2) Minimum 2 years experience in clinical research or a related field 3) In-depth knowledge of GCP guidelines and regulatory requirements 4) Proficiency in MS Word and Excel 5) Excellent written and verbal communication skills 6) Willingness to travel (up to 25%)