We are seeking a Research Assistant (regular, full-time) to join the Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction (LeAAPS) trial team at PHRI.
As a Research Assistant, you will:
- Create and test data reports, databases, edit checks, case report forms (CRFs), and related programs, technology, and support tools for efficient collection, analysis, and reporting
- Troubleshooting and problem-solving issues with study systems, reports, data queries
- Support Research Coordinator/Program Manager to oversee the management and reporting of data
- Coordinate logistics, review requirements, and confirm accuracy for the shipping and collection of materials and supplies for the main study as well as for sub-studies
- Request and review reports from the Statistics and/or ICT Department(s) to maintain data integrity of the study
- Develop study support tools, reports, and trackers (i.e. manuals, instructional documents)
- Maintain and manage access to study database and systems for all study personnel
- Maintain ongoing communication with sites regarding all study related materials and issues to ensure all materials are up to date.
- Compile and review documentation required for Good Clinical Practice and/or as required from the study sponsor
- Coordinate drug supply and demand with study sponsor and IP manufacturer, packager, distributor to prevent shortages and overages
- Perform activities related to major protocol deviations and data transfers
- Provide training to PHRI and external study staff
- Implement protocol amendments in consultation with the Research Coordinator/Program Manager
- Review IP-related information provided on study CRFs. Apply and resolve queries.
- Provide user access to IP management systems (IVRS/IWRS)
- Other duties as assigned.
Qualifications include:
- Bachelor’s degree related to Health or Business preferred
- Minimum of 2 years of data management and research/clinical trials experience
- Proficient in Microsoft Office Suite
- Ability to problem-solve, work independently, adapt to constant change, take initiative, self-motivate, be flexible, and multi-task
- Excellent communication (written and verbal) and interpersonal skills
- Familiarity with electronic data capture software and data authoring software such as FrameMaker, iDataFax, MedDRA, RedCap, SAS Visual Analytics
This is a Hamilton Health Sciences regular full-time posting: 37.5 hours/week Monday through Friday, based in Hamilton, Ontario.
For more information - and to apply - go to: Job Number 110232
Deadline for applications: December 19, 2023, 11:59 pm ET.
