The Varied Role of a CTA
The role of a Clinical Trial Administrator (CTA) can be quite varied depending upon the study drug and the stage within the trial. CTA’s also need to adapt depending upon the involvement and requirements of the client company.
Here we speak with Jennie Rathore one of the CTA’s here at Illingworth Research. “I really enjoy the variety of the roles and the rewards of being a part of the clinical trial from start to finish of that study phase.” We join Jennie during the start-up phase of a study she was working recently. Focusing on progressing both regulatory and ethics submissions.
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- File new site-specific documents submitted by sponsor as per our filing matrix within an eTMF (Electronic Trial Master File).
- Weekly internal catch-up, good call all happy that everything is going smoothly. Couple of queries for sponsor which PM (Project Manager) is investigating.
- Liaise with sponsor regarding site documents wording to make appropriate for UK NHS site.
- Creation of an emergency contact card for the UK study site as per the Illingworth SOPs (Standard Operating Procedures).
Big day today... a new study protocol version is issued.
- Add new protocol and supporting amendments file to eTMF.
- Upload new documents to IRAS regulatory submission.
- Release these documents to site PI as per sponsors request.
- Work through IRAS submission carefully and amend elements which mention protocol and alter inclusion criteria as per protocol amendments.
- Sponsor weekly teleconference – depending on the sponsor’s request I’m not always required on these ones but with the new Protocol being issued, we felt it was important we were all 100% clear on the changes and the reasoning behind them.
- Take meeting minutes and preparing for PM and Sponsor approval.
- File meeting minutes following gaining approval from PM and study sponsor.
- Complete and submit my weekly hours worked on the study.
Illingworth Research aims to deliver CTA's a unique, fun, and friendly atmosphere. We have regular team meetings to ensure our CTA's have ample opportunity to speak directly managers and colleagues. Company-wide meetings give you the opportunity to meet with the whole Illingworth Research team, including all UK, US and Australia staff. These 2-day meetings cover a variety of subjects, of which each member of staff has the opportunity to present. For example, if you have a particular interest in a certain therapeutic area or new clinical trial regulation, then you have the opportunity to present to your fellow colleagues and share your knowledge.