Describe how knowledge and skills in this course can be applied while working
hi there.The following assignment is to connect the course concepts to the work place. so I am posting my job responsibilites and text book.Try to connect between the text book concepts and the my job description.
job description Clinical trial associate
- Key support role to senior Clinical Operations staff; ensures that delegated components of clinical trials are executed to expected and specified quality standards
- Responsible for study laboratory sample management, including tracking and vendor management support
- Collect trial information and disseminate it to the internal project team, the CRO, and other stakeholders
- Schedule and coordinate study meetings, materials and agendas; recording and disseminating decisions and actions
- Responsible for quality control of the eTMF including maintenance and oversight
- Coordinate and manage version control of clinical documents.
- Prepare distribution of copies of finalized protocol and study documents.
- Draft and coordinate the ICF review
- Assist in development and monitor compliance of study plans, including Lab Manual, Clinical Monitoring Plan, Study Plan, Study Vendor Oversight Plan, Pharmacy Manual, and other.
- Assist in responding to Data Correction Forms (DCFs) and track DCF follow-up and completion activities.
- Assist in the coordination and tracking of clinical supply shipments, including review and approval of Regulatory Documentation Packages
- Assist in the creation and updating of standardized clinical trial tools, processes, and SOPs
- Organize and maintain tracking systems and tools to support the conduct of a clinical study from start-up to close-out
Use the text book and also one outside source
Provide a reflection of at least 500 words (or 2 pages double spaced) of how the knowledge, skills, or theories of this course have been applied, or could be applied, in a practical manner to your current work environment. If you are not currently working, share times when you have or could observe these theories and knowledge could be applied to an employment opportunity in your field of study.
- Provide a 500 word (or 2 pages double spaced) minimum reflection.
- Use of proper APA formatting and citations. If supporting evidence from outside resources is used those must be properly cited.
- Share a personal connection that identifies specific knowledge and theories from this course.
- Demonstrate a connection to your current work environment. If you are not employed, demonstrate a connection to your desired work environment.
- You should NOT, provide an overview of the assignments assigned in the course. The assignment asks that you reflect how the knowledge and skills obtained through meeting course objectives were applied or could be applied in the workplace
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Word limit : 592