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Clinical Research Monitoring and Coordination
This online multi-media course provides essential training to meet job requirements in clinical trial monitoring and study management. The course provides key foundation skills and terminology for success and qualification as a clinical research associate (CRA) or clinical research coordinator (CRC) as well as related CTM, CTS, CPS titles. The course is also ideal for Medical Monitors, Clinical Scientists and Project Managers who want technical and regulatory knowledge of Good Clinical Practice (GCP) related to pharmaceutical R&D. The course is certified through TransCelerate and ANCC organizations, meeting all ICH GCP E6 training requirements and clinical standards for global trial sponsors.
Whether you are seeking your first position in clinical research or need to quickly enhance a detailed knowledge of global GCP standards, this University certificate course uniquely qualifies you in clinical research & development to work directly with study patients or manage the research functions in clinics, hospitals and/or global pharmaceutical companies. Course completion allows you to join the ever-growing demand for trained clinical study professionals in the search for exciting state-of-art medical cures and therapeutics.
- Learn the drug development process and roles/opportunities in clinical research
- Apply and understand the essentials of Good Clinical Practice
- Establish efficient subject recruitment, monitoring and reporting techniques
- Institute and obtain proper informed consent and regulatory approvals
- Identify ethical issues and their impact on the development of new products
- Develop a detailed clinical trial protocol and efficient data collection methods
- Finalize Study budget and key Clinical Data Management procedures
- Identify adverse events and proper reporting standards
- Produce study analyses and final reports
- Examine study audits and inspections and the types of sponsor-investigator site visits
- Employ practical Regulatory Affairs approaches to study approval, review and filing
Student completion times range from two weeks to four months.
ALH 170 900
- Open Registration: Online multi-media, self-paced course, , 24-7 access and support on any smart phone, tablet, laptop or desktop computer
John F. Arditi, B.S. M.S. and Juliet L. Wheatley
Instructor: John F. Arditi, B.S., M.S., R&D Executive and Consultant
Course Administrator: Juliet L. Wheatley. Please direct course questions to email@example.com
This ICH E6 GCP Investigator Site Training meets the Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma Inc. as necessary to enable mutual recognition of GCP training among trial sponsors.