As a Clinical Research Associate, you will help design, plan and implement the overall direction of clinical research projects. Your primary responsibility will be to assist the study team with all operational activities for new infectious disease diagnostic test products under clinical evaluation.
- Independently be responsible for all activities of the clinical trial including clinical site selection, study initiation visits, training of on-site personnel, study close-out visits and trial monitoring with on-site audits of clinical data for accuracy and completeness, and clinical report preparation and presentation.
- Devise and write study protocols, investigator manuals, site specific instruction manuals and design case report forms for new and modified products.
- Assist in the preparation of clinical reports and clinical/non-clinical sections of regulatory submissions and prepare scientific abstracts, posters and publications arising from the trials.
- Assist with the management of key study parameters (i.e. start-up activities, enrollment, data collection, etc.).
- Responsible for timely identification of problems or issues that could affect the results or timely completion of the trial, or any protocol deviations, and for suggesting mechanisms for solving the problem.