The Clinical Research Coordinator Certificate is designed to provide entry-level specialization in the clinical trial operations. The Clinical Research Coordinator supports, facilitates and coordinates clinical trial activities and plays a critical role in managing the clinical trial. The curriculum provides introduction to clinical trials in phases 1-5, obtaining informed consent, educating the patient on the clinical trial process, risks and benefits while ensuring Good Clinical Practice Standards are followed. The Clinical Research Coordinator reports to the Principle Investigator and the Institutional Review Board and manages the recruitment and retention of subjects for clinical trial while ensuring vulnerable subjects are protected from risk. Clinical Trials consist of research for pharmacologics, investigational devices, biologics and social/behavior studies. Students will also learn the sources of data collection, source documents and case forms used in the clinical research process, as well as privacy, security and confidentiality protocols.
Upon successful completion, students will be able to:
- Explain the roles of the clinical research team, their specific roles and legal requirements.
- Examine the Drug Development Process regarding the definitions, regulations and process for investigational new drug (IND) and new drug applications (NDA).
- Analyze the drug, device and biologic development process, including protocol development, case form report development, feasibility of the clinical trial and developing a budget for clinical study.
- Examine and evaluate the use of Code of Federal Regulations in the clinical trial process.
- Explain adverse and severe drug reactions and adverse events, evaluate the process of the Institutional Review Board notification of adverse events.
- Discuss procedural and management issues regarding utilization and disposition of informed consent and source documents.
- Develop recruitment plans using healthcare marketing strategies and retention plans for clinical trials using informed consent and the community of interest.
- Examine research ethics through therapeutic and disease misconceptions, understanding bias and randomization.
- Apply the concepts of Good Clinical Practice and understand the International Conference on Harmonization.
Employers are increasingly looking for clinical trials staff with a developed set of core competencies such as data classification, health informatics and healthcare statistics.
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