Job Description

• Support Research Coordinator 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
• 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
• Attend regular meetings prepare minutes and lines of actions.
• Other working conditions may involve field work and irregular hours, such as weekend and evening work.
• Enrolling participants via telephone, completing and tracking follow-up, medical chart reviews, and ongoing communication with project teams.

Qualifications

Qualifications:
Bachelor\'s degree in a relevant field of study.
Requires 2 years of relevant experience.
Proficient working knowledge of the Microsoft Office Suite and research-specific databases, specifically Word, Excel, and REDCap.
Full working knowledge of safety regulations and government legislation is an asset
Excellent written and oral communication skills
Ability to manage time and determine priorities
Effective project management, personal initiative and teamwork necessary

Assets:
Clinical Trial experience.
GCP, TCPS2 training

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

Hamilton Health Sciences