Job Description

• Support PI to oversee the operation and management of research projects.
• Adhere to Good Clinical Practice and incorporate GCP requirements in all stages of research projects from start up to close up.
• Adhere to regulatory and local requirements (i.e. annual safety reports, periodic safety reports).
• Adhere to timelines and milestones.
• Provide support to all collaborators (sites/countries) on a regular basis through communication.
• Liaise with internal and external collaborators involved with research projects, to develop study agreements, complete regulatory/ethics submissions, and process payments for sites and other collaborators.
• Compile, review, and file essential documents
• Help with training and orientation of study sites and staff.
• Help develop Manual of Operations and other study support tools, reports, and trackers.
• Help create and test data reports, databases, audit case report forms (CRFs), and related programs
• Help coordinate the process of transferring prepared study data to the study sponsor
• Respond to data-related questions and query from internal and external partners
• 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.
• Prepare for meetings and teleconferences
• Implement all study related amendments requested by the Principal Investigator
• Respond to daily inquiries and facilitate communications on behalf of the central site.
• Help with publications and other study related documentations.
• Perform activities related to major protocol deviations
• Creation of data collection forms.
• Regular communication with external parties
• Help provide training to staff
• Help provide training to external study staff
• Attend regular meetings prepare minutes and lines of actions.

Qualifications

Qualifications:
Bachelor\'s degree in a relevant field of study.
Requires 2 years of relevant experience.

Assets:
Clinical Trial experience.
GCP, TCPS2 training
Experience with cognitive measures

As a condition of employment, you are required to submit proof of full COVID-19 vaccination to Employee Health Services.

Hamilton Health Sciences