Throughout the Clinical Trials Management and Regulatory Compliance certificate, students develop procedural and administrative understanding of the clinical trials process and build the skills and knowledge necessary to lead clinical research studies.
This comprehensive certificate program provides rigorous clinical research training across the entire clinical trials process, from the perspective of the clinical study site as well as that of the sponsor or monitor. The broad curriculum covers ICH good clinical practice guidelines, regulatory requirements and compliance, detecting fraud and misconduct, and statistics for clinical research. Students will build the skills and knowledge to initiate clinical research studies, apply monitoring methods, and write documents and reports, while understanding and abiding by FDA regulations and International Conference on Harmonization (ICH) guidelines.
Instructors are experts in clinical trials and clinical research. Program instructors average over 10 years of experience in the field and have expertise in all areas of clinical trials. Professional affiliations include managers of clinical trials programs, business executives in related medical companies, and certified American Society for Quality (ASQ) members.
Interested in learning more about our clinical trials management certificate? Contact us today to request more information!