Clinical Trials Assistant

5 months ago

Manchester, United Kingdom The Christie NHS Foundation Trust Full time

An exciting opportunity to appoint a Clinical Trials Assistant has arisen within the Radiology Department at The Christie NHS Foundation Trust supporting Clinical Trials.
The Radiology Clinical Trial team supports a vast range of clinical trials led across different specialties in Research and Innovation. The role will be supporting Christie Led research projects within Radiology.
We are seeking enthusiastic and a highly motivated individual, who has a keen interest in, and a basic understanding of, clinical research.
Key skills required are excellent organisation and communication skills, and an ability to work well both in a team and using their own initiative.
Applicants should meet all the essential criteria described in the job description as a minimum, including a good understanding of Microsoft Word and Excel, and previous administrative experience

The focus of these roles is to assist the Radiology Clinical trials team by providing a high-quality clerical and administrative service according to ICH-Good Clinical Practice (GCP), standard operating procedures (SOPs) and Trust policies.
The role encompasses assisting the radiology clinical trials team with filing and archiving of clinical trial documentation, copying radiology scans, management of supplies and equipment, supporting visits from trial monitors and completing team and patient trackers and reports, along with general administrative tasks as required by the clinical trial team.

The Christie is one of Europe’s leading cancer centres, treating over 60,000 patients a year. We are based in Manchester and serve a population of 3.2 million across Greater Manchester & Cheshire, but as a national specialist around 15% patients are referred to us from other parts of the country. We provide radiotherapy through one of the largest radiotherapy departments in the world; chemotherapy on site and through 14 other hospitals; highly specialist surgery for complex and rare cancer; and a wide range of support and diagnostic services. We are also an international leader in research, with world first breakthroughs for over 100 years. We run one of the largest early clinical trial units in Europe with over 300 trials every year. Cancer research in Manchester, most of which is undertaken on the Christie site, has been officially ranked the best in the UK.
We are a friendly team that supports our staff developing new skills and practices and are keen for all members of our team to continue to learn and share knowledge.
I would strongly encourage interested applicants to contact the team to further discuss the roles and how you can become a key member of this exemplary team.
This is a part-time role, 0.6 wte, with flexibility and hybrid working.

ORGANISATIONAL ARRANGEMENTS

**Accountable to**: Senior Research Project Manager in Radiology

**Other Accountabilities**: Clinical Trial Radiographers

Administrative Management
- Maintain appropriate control of radiology imaging manuals and essential documentation in accordance with ICH-GCP and Trust SOPs to ensure they are kept inspection ready and accessible at all times.
- Work in conjunction with CT radiographers and Research Teams to agree priorities for studies in set up and amendments
- Attend project related meetings, or teleconferences, as necessary, producing minutes in a timely manner.
- Assist with general preparation for audit and inspections within assigned teams, under the direct supervision of the Clinical Trials Radiographers.
- Regular requirement to develop or present reports relating to data held in one or more of the research radiology information systems
- Set up and initiation of allocated trials within an assigned team, under the guidance of the Senior Research Project Manager.
- Provide administrative support to the Clinical Research Nurses and Principal Investigators for safety reporting in accordance with protocol requirements.
- Maintain investigator site files and essential documentation in accordance with ICH-GCP and Trust SOPs to ensure they are kept inspection ready 2at all times.
- Complete case report forms as per sponsor requirements, and liaise with clinical trial monitors to ensure the data sent is valid and their requirements are met at site monitoring visits.
- Process trial amendment submissions in accordance with ICH-GCP and Trust SOPs and timelines.
- Archive all trial radiology documents following the Trust’s archiving guidelines.

Information management
- Maintain the radiology clinical trials database including accurate patient data entry, imaging, invoicing costs for individual patient examinations, and resolution of discrepancies between Trust information systems (CRIS, CWP) for patients taking part in clinical trials associated with radiology.
- Produce copy scan images for research purposes ensuring GCP and GDPR requirements are followed in the production and transfer of images.
- Maintain tracking systems i.e. attendance and appointment stats, copy scan logs, clini

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