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The online Clinical Research Specialist certificate program focuses on developing the concepts, skills and techniques required to work in the clinical research field. You will gain knowledge and skills in the planning and management of clinical research including practices related to the organization, execution and monitoring of clinical trials.There is a focus on maintaining good clinical practice (GCP) as presented by the International Conference on Harmonization (ICH), and the importance of data collection, analysis, recording, and auditing.You will become familiar with the regulations and guidelines established to ensure clinical trials are conducted ethically and in ways that respects the rights of clinical trial participants.It provides an overview on clinical research specialist job function and covers core sponsor and research site activities that promote the successful monitoring of studies of pharmaceutical drugs. Good Clinical Practice (GCP) skills are reinforced through activities such as non-graded multiple choice questions and scenario review. Non-graded knowledge assessment will follow each module. Communication and effective time management skills as being essential to clinical research professionals are also covered.
Upon completion of this course, participants should be able to:
- Describe the drug development process, the importance of Good Clinical Practice (GCP), and the roles and responsibilities of the research team
- Perform the steps involved in monitoring the investigational site: Pre-visit, during the visit, and post-visit
- Maintain ethical, legal, regulatory, and professional standards associated with clinical research.
- Evaluate clinical research practices according to recognized Quality Assurance Process.
- Outline required elements of the informed consent
- Define the regulatory requirements, explain the differences between ICH GCP E6 and FDA requirements, and describe the elements of a protocol
- Acquire techniques of time management as being the most precious resource
- Module 1: Investigational Product Development Process: Drug and Medical Device, Good Clinical Practice (GCP), and Clinical Research Team Roles and Responsibilities
- Module 2: IRB, Clinical Study Protocol Elements and Amendments
- Module 3: Informed Consent
- Module 4: Investigational Product Accountability
- Module 5: Safety Definitions and Reporting Requirements
- Module 6: Source Document Verification
- Module 7: Monitoring the Study
- Module 8 : Monitoring Visit Reports, Follow-Up Letters, and Contact Reports
- Module 9: Regulatory Compliance and Quality Assurance: Audits and Inspections
- Module 10: Effective Time Management Skills
- Module 11: Communication Skills
At a Glance
- Target Audience:
- This course is designed forthose currently working in the industry in a different role seeking to change roles
- Clinical Research Monitors with less than two years of experience – in-house or field-based
- New Hires Individuals and recently life science graduates who would like to pursue a career in clinical research industry.
- Certified Clinical Research Specialists who would like to maintain their certification by earning credits.
- Learning Level: Basic
- Total Length of Course:18 Hours
- CACRSCredits: 18
- Delivery Formats: Online
- Certificate Program: A Certificate of completion will be sent by mail in two weeks after passing the final online MCQs exam. Certificate contains the logo and the seal of the association.
Enrollment Period: Access to the program is valid for 6 months