Research Assistant

Hamilton Health Sciences•Hamilton, ON

About The Position

This role supports the Research Coordinator in managing and overseeing research projects. Key responsibilities include adhering to Good Clinical Practice (GCP) and regulatory requirements, managing project timelines, and facilitating communication and collaboration with internal and external partners. The position involves document management, training support, data handling, and logistical coordination for study materials. The role also includes preparing for meetings, implementing protocol amendments, assisting with publications, managing deviations, and creating data collection forms. Direct participant interaction may also be required, including enrollment, follow-up, and medical chart reviews.

Requirements

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

Nice To Haves

Full working knowledge of safety regulations and government legislation is an asset.
Clinical Trial experience.
GCP, TCPS2 training.

Responsibilities

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.
Enrolling participants via telephone, completing and tracking follow-up, medical chart reviews, and ongoing communication with project teams.