CLINICAL TRIAL ADMINISTRATOR (CTA) - (BEGINNERS)
CLINICAL TRIAL ADMINISTRATOR (CTA)
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.
Accredited classroom based training - Duration 3 days. The role of the CTA will be covered in intensive detail with visual aids and hands-on training provided by experienced industry professionals.
- 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
What will be covered in this course?
- 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
Objectives of the course
It is often said that the best way into clinical research at a higher level is via a Clinical Trial Administrator (CTA) role. There is truth to this, the CTA will give you a firm grounding in the world of clinical trials and better prepare you for more responsible roles later on in your career. Often companies will not even consider you for roles such as Clinical Research Associate (CRA) until you have spent some time at the CTA level. Our advice would be the CTA is the preferred entry level route into clinical trials.