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Clinical Data Manager

During the Clinical Data Management course, students will gain in-depth knowledge of the clinical data management process. They will learn how to manage and analyze clinical trial data, from study start-up to database lock. This includes setting up the data management system, EDC systems, and drafting data transfer agreements. Students will also learn about designing data collection instruments, developing data management plans, and ensuring the quality of clinical trial data through effective quality control and assurance procedures, developing data management plans and more. The course will provide students with a thorough understanding of the regulatory requirements for clinical trial data management, including adherence to Good Clinical Data Management Practice (GCDMP). By the end of the course, students will be equipped with the knowledge and practical skills to excel in their roles as clinical data manager.

Clinical Research Associate

During the Clinical Research Associate (CRA) course, students will learn about the roles and responsibilities of a CRA. The course will including site selection visit (SSV), site initiation visit (SIV), interim monitoring visit (IMV) and study close-out visit information and more. They will gain an understanding of the regulatory requirements and Good Clinical Practice (GCP) guidelines, including how to maintain trial documentation, ensure patient safety, and identify and resolve protocol deviations. The course will also cover essential skills such as communication, problem-solving, and decision-making, which are critical to success as a CRA. Overall, the CRA course is designed to equip students with the knowledge and practical skills needed to effectively monitor clinical trials and ensure regulatory compliance.