What You Will Learn!
- Ethical principals guiding clinical research and regulatory requirements of IRB related to research study start up, implementation and closure
- 4 weeks
- Critically think over protocols.
- Review research protocols with me to apply principles learnt in the course.
- Define the roles and responsibilities of IRB, FDA, sponsors, and investigators along with overseeing the overall operational workflow.
Description
This intensive program is designed to equip aspiring CRAs with the knowledge, skills, and confidence needed to excel in the dynamic field of clinical research. I leveraged up-to-date research and ongoing discussions regarding FDA rules and regulations, making use of easily accessible FDA and federal laws that are available online. I conveyed all information through video presentations in, concise downloadable notes, and high order thinking questions in English.
The course encompasses:
Fundamentals of Clinical Research: Gain a solid foundation in the principles and regulations governing clinical research, including Good Clinical Practice (GCP) guidelines.
Clinical Trial Management: Learn the end-to-end process of planning, conducting, monitoring, and reporting on clinical trials.
Ethical and Regulatory Compliance: Explore the ethical considerations and regulatory requirements that govern human subject research.
Quality Assurance and Auditing: Understand how to maintain the highest standards of quality and compliance within clinical research projects.
Risk Assessment and Mitigation: Identify potential risks in clinical trials and develop strategies to mitigate them effectively.
Protocol and Investigator Interaction: Learn to collaborate with investigators and research teams to ensure study success.
Exam Readiness: Benefit from practice exams, quizzes, and real-world case studies to enhance your exam preparedness.
Upon completing this course, you'll be well-prepared to tackle the Clinical Research Associate certification exam with confidence. Join us and take the first step towards a rewarding career in clinical research. Your future as a CRA starts here!
Who Should Attend!
- Aspiring Clinical Research Associates, students volunteering in research, journal reviewers and editors.
- People with brief professional experience in clinical research looking to expand their horizon and find out what lies beyond the barrier.