Before new drugs, biologics or medical devices reach the market, it enters a clinical research trial to investigate whether the new treatment or device is safe and effective for humans. As more funds are funneled into the development of new drugs, the need for qualified clinical researchers to conduct and administer these projects will continue to grow. With this certificate, you will master practical aspects of running and managing a clinical trial, including trial design and phases, good clinical practices, the drug discovery and development process, FDA regulations and ICH guidelines, data management and analysis, operations, global studies, quality control and assurance, compliance and bioethics
There are no prerequisites for this but a bachelor's degree is recommended, preferably in a science or technical field.
- Develop Simple, Efficient, and Effective Quality Systems (SEEQS)
- Utilize SEEQS for detecting root causes of performance deficiencies and
developing and implementing effective Corrective and Preventive Action (CAPA)
- Select investigators and records for auditing or special monitoring emphasis
- Write audit plans and reports