Clinical Trials Assistant Review

My placement was undertaken at The Christie NHS Foundation Trust, a specialist cancer centre located in Manchester and recognised as one of Europe’s largest single-site cancer hospitals as a Clinical Trials Assistant (CTA). The role provided me with an opportunity to understand how clinical research is conducted within an NHS setting and how different processes contribute to the safe and effective delivery of studies. However, working as part of a clinical research team allowed me to appreciate the complexity of trial management, the importance of regulatory compliance and the significant contribution made by research staff in supporting patient care. Throughout the placement, I developed technical skills related to clinical trial administration, data management, regulatory documentation, and laboratory procedures, while also strengthening important professional skills including communication, organisation, teamwork, and problem-solving. One of my main responsibilities as a CTA was supporting the management and maintenance of clinical trial data. Additionally, clinical trial databases generate queries when information is missing, inconsistent or requires clarification. By resolving these queries, I review source documents, communicate with relevant members of the clinical team and ensuring that appropriate corrections or explanations were documented. Patient screening was another important aspect of my CTA role. Before patients can participate in a clinical trial, they must meet specific eligibility criteria outlined in the study protocol. I supported the screening process by reviewing patient information and assisting the research team in identifying potentially eligible participants. I also maintained essential trial documentation, including Investigator Site Files (ISFs) and Trial Master Files (TMFs). These documents provide evidence that a clinical trial is being conducted according to regulatory requirements, ethical standards, and Good Clinical Practice (GCP) guidelines. Another area of learning was the management of protocol modifications. Clinical trials may require changes to procedures, eligibility criteria, documentation, or treatment approaches during their duration. These modifications must be reviewed, approved, and implemented carefully to ensure participant safety and compliance. During my placement, I have reviewed and implemented modifications.

I have undertaken many projects in my placement year. One of which includes actively completing all tasks described above, along with invoicing for many clinical trials. I have worked on a range of phase one to three trials called M23-324, TERZO, IELSG48 (RITZ), Echelon-1 and PORTAL. All are CTIMPS with IMP administration. By having a range of tasks to complete on all clinical trials, I feel well equipped to tackle any new tasks that arises. I actively ask for more tasks to complete. Therefore, I was assigned to return a plethora of tumour blocks to the source hospital as they were previously returned from the Sponsor company after archival and not actioned. I have organised 40+ surplus tumour blocks and super-frost slides documentation to return all samples to the correct hospital. This has included using our team tumour blocks tracker, tumour block return letter and receipt and following the SOP and team specific notes. Many samples were difficult to locate as during redaction some laboratory numbers are erased prior sending to Sponsor.

Throughout the placement, I developed technical skills related to clinical trial administration, data management, regulatory documentation, and laboratory procedures, while also strengthening important professional skills including communication, organisation, teamwork, and problem-solving.

I have had many training opportunities within the team as my line manager is always happy for me to attend any seminars, training days, or conferences that I feel would be beneficial to myself. I have had the privilege in attending the GM Cancer Conference, where I liaised with cancer research professionals about the innovative and upcoming progress of cancer outreach to the Manchester community. This was an eye-opening experience as the NHS is sometimes talked badly upon, however the willingness and openness to change is promising. The future of the NHS is heavily relied upon change, innovation, and innovative ideas. I have attended many training sessions within the Trust to aid my Lymphoma Research Team Induction by my line manager. I additionally organised a CRF lab tour to gauge an understanding of the laboratory process and environment. This was a fantastic opportunity as it links with my degree, and it may become a subject of interest in the future. I addition all had support from university staff members, who were available to offer guidance during the academic year.

The culture at the Christie is incredible. I have loved working at this hospital in particular as everyone is extremely welcoming and supportive. We encourage learning and growth through experiences, even mistakes. Therefore, the learning culture is extremely positive. I received a lot of support and guidance from my colleagues and wider research teams.

I really enjoyed my placement, I am glad I am stating on as part time staff.

Yes