Clinical research operation
Building on the success of the 2017 course, the clinical research operations teach the best practices for coordinating the clinical trial process including study design and protocol development, ethics, GCP ICH, data management, regulatory affairs, safety monitoring and practical management skills.
The course is free for successful applicants and will benefit study coordinators working in all disease areas.
At the end of the course, successful participants will be able to:
• Prepare sites for clinical trial start up through an overall understanding of the clinical trial process from project management to research design and protocol development.
• Demonstrate the ability to effectively conduct clinical trials using patient recruitment and retention approaches, data management, data monitoring, pharmacovigilance, safety reporting and good financial practices.
• Design and maintain the quality system of a clinical trial through implementing SOPs, handling audits and inspections, as well as other aspects of QA and QC.
• Identify and address key challenges in managing research sites including developing and maintaining capacity, doing community engagement and managing grants.
• Develop people management skills and techniques that will be useful in working with internal colleagues and external partners
WHERE CAN THIS CAREER TAKE ME?
A career in clinical operations can take you anywhere within the clinical research network, the sky’s the limit really. As we know clinical operations is key to the smooth running of a clinical trial and therefore a role within this area of the drug development process will no doubt lead to further opportunities. Being positioned centrally with the process of a trial puts most people in front of a number of key opinion leaders and major stakeholders, which consequently builds an individual’s network of contacts. This can help greatly in creating opportunities and having your talent noticed.
Upward and sideways moves are therefore more prevalent within the clinical operations sector and these moves can happen relatively quickly due to the vast contacts network. The natural progression within clinical operations is to move up to Clinical Director or Clinical Operations Lead, where the overall operational running of a trial is your responsibility. That said further developments can lead to heading up a particular therapy area department and/or moving somewhat sideways into clinical development, where you’ll be more involved in the design of a trial, how it functions and the science behind the trial.
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