Administrative Support II - Clinical Trials Assistant, Regulatory Team

The Administrative Support II - Regulatory Clinical Trials Assistant is a key multi-skilled administrative position that helps to support the implementation and facilitation of Clinical Trials within our Unit. This position will help organize and complete various administrative tasks associated with maintaining the educational requirements of, and initiation and oversight of clinical trials conducted under Good Clinical Practices. They will perform data entry, meeting coordination and set up, and many other related tasks. They help organize occasional audits & numerous study monitoring visits on a daily basis, type letters and agenda's, take meeting minutes and ensure the completeness or delivery of all relevant documentation. The incumbent must demonstrate the ability to recognize and maintain confidential information, have highly developed organizational skills, and keen attention to detail. They will also multi-task effectively in a busy area with multiple interruptions and competing demands and have good problem solving and communication skills. They will work cooperatively and professionally with clinical trials staff and physicians, and our external vendors. Lastly, they are able to function both independently and as a team member in a fast paced, dynamic office environment. This position supports our Quality & Regulatory team and plays a major role in supporting the efficient coordination of important related activities.

As an Administrative Support II, you will require administrative or specialized skills and knowledge to support procedures, practices and initiatives within a department or program.

Completion of Grade 12 or equivalent.

1-2 years’ experience in a clinical trials setting. Understanding of clinical trial regulatory documents, monitoring and start-up processes. Proficient in of Microsoft Outlook, Word, Excel, PowerPoint and Adobe Acrobat programs. Proven ability to prioritize workload and multi-task effectively in a busy area with multiple interruptions and competing demands. Prior experience working with databases and knowledge of document management systems. Physical demands of the job include sitting for extended periods, lifting office/medical supplies and equipment weighing up to 40 lbs., and using repetitive motions, lifting, bending, reaching and standing for prolonged periods. Must be able to transport large volumes of materials (office supplies, charts, boxes, etc.) to various areas on a regular basis, and push/pull loaded carts. Due to the intense daily interactions and considerable coordination requirements with our external vendors, optimal daily work attendance with minimal absences is required. To ensure your skills and qualifications are considered, please attach a resume and cover letter with your application indicating how your education and experience meet the requirements of this position.

Post-secondary education in a health-related field preferred (equivalent combinations of education and experience will be considered). Experience completing clinical trials regulatory documentation. Prior experience with databases or document management systems. Training in Good Clinical Practice, ICH and Health Canada Regulatory requirements.