Research Assistant

• 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

• 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.

• Bachelor's degree in a relevant field of study.
• Requires 2 years of relevant experience.

Assets

• Clinical Trial experience.
• GCP, TCPS2 training
• Degree in Health Sciences, Life Sciences, or a related field
• Strong organizational, communication, and data management skills.
• Previous experience in clinical research, patient recruitment, data collection, research ethics documentation, and coordination of clinical studies is preferred.