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.