Clinical Trial Administrator (CTA) is a trained professional who helps to facilitate a clinical trial. As a CTA you will primarily manage the administrative aspects of a number of clinical trials for every stage of the process. As a CTA you will primarily manage the administrative aspects of a number of clinical trials for every stage of the process.This is often seen as the gateway role to becoming a Clinical Research Associate (CRA).
What is the role of a CTA?
- Act as the pivotal point of contact and support for the clinical team.
- Assist the team with all aspects of administration to ensure the smooth running of the clinical trial programme.
- Set up, maintain and manage the trial master file (TMF) (e-TMF and or Paper TMF) in accordance with GCP.
- Set up, maintain and manage the study related documentation in accordance with GCP.
- Assist with the preparation of essential clinical trial documentation.
- Maintain clinical trial tracking systems ensuring they are up-to-date and accurate.
- Where required provide regular /ad-hoc reports from tracking systems.
- To ensure standard working practices are followed in order to provide an effective professional administration service for Clinical Studies.
- Ensure that internal/external enquiries are dealt with professionally and effectively.
- Be aware, understand and comply with company/department standard procedures when dealing with systems and the Regulatory and Legal (ICH GCP, SOPs/WI) requirements that affect the role.
- Assist in training of Clinical Research Team in the use of trial tracking systems and filing in TMF
- Facilitate production of required study documents and other documents, including the collation of documentation for study related meetings.
- Monitor study supplies/storage levels and organise the timely, accurate distribution of study related documentation, equipment and investigator files to investigator sites.
- Understand and comply with the requirements for the efficient distribution and maintenance of Investigator Brochures.
- Understand and comply with the requirements for the efficient processing of Serious Adverse Event documentation, including clinical safety reports
Key Skills to be a CTA
Experience / Qualifications
- An eye for detail
- Team player,
- Proficient in Word, Excel, Microsoft Project
- Degree in life science or equivalent is desirable but is not essential
Entry Level CTA Introduction to Clinical Trials
What will be covered in this course?
This module will look at:
- What is a clinical trial
- The four clinical trial stages
- Exploring the necessity for clinical trials
- The key personnel involved in clinical trials safeguarding subjects participation
- The rules and regulations governing clinical trials (ICH-GCP)
- The overall process for a clinical trial
- The role of the clinical trial administrator in the context of a clinical trial
- Review the documents required for a clinical trial and the master file i.e. TMF
Who is this course for?
If you are new to clinical research or an administrator who has just started working in clinical trials (entry level CTAs) this module is specifically designed for you. Alternatively, you may be a graduate whose has just left university wishing to pursue a career in clinical trials. This is a good starter course that will equip you with the insight into the clinical trial process, terminology and can show you how to enter the clinical trial industry.
will I benefit from taking this course?
By the end of this course you will:
- Understand why trials are necessary
- Understand the stages and phases involved in clinical trial development
- Understand the life cycle of a clinical trial.
- Understand why clinical trials are needed
- Understand who regulates clinical trials and what are the rules, regulations (GCP)
- Understand who the key professions involved in clinical research are.
- Understand where the CTA role and responsibilities fit in
- Understand some key terminology and acronyms
- Identify the key safeguards required to ensure patient safety and well being
- Be able to identify the key safeguards required to ensure data quality standards are met
- Understand what is a Trial Master file and the key documentation that make up the file.
Minimum entry requirements: 5 GCSE passes one in a science subject.
CTA Clinical - Trial Administrator
CRA Clinical - Research Associate
CTM Clinical - Trial Manager
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