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Job description

An exciting opportunity has arisen within the Research and Innovation Office at The Christie, for a Research Archivist and Information Assistant.

The Research Archivist and Information Assistant is responsible for the management of the research archive at The Christie. The role includes ensuring that all research documents are stored, catalogued and eventually destroyed in accordance with Trust guidelines and regulatory requirements.

As the successful applicant, you will demonstrate previous experience in the storage and management of documentation. You will be qualified to at least diploma level or have an equivalent level of experience. You should be IT literate with knowledge of the clinical trials process and have an awareness of GDPR regulations. We are looking for a candidate with good organisation and communication skills, who can work well both in a team and using their own initiative and with excellent attention to detail.

As the postholder, you will be responsible for the archiving of study documentation within the Research & Innovation Division of the Trust. You will ensure that all activities are carried out in accordance with the principles of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), Trust policies and other regulatory requirements. You will also be required to assist the R&I office in other administrative areas as required.

You will arrange collection and preparation of clinical study documentation in alignment with Trust SOPs. You will arrange the shipment of clinical study documentation to an offsite facility and will be responsible for the destruction of documents at the allocated time. You will build constructive relationships with study sponsors and investigators about the deadlines for such activity.

When required, you will arrange for the retrieval of documents which are requested by the research teams or by other authorised staff. You are responsible for the budget management of all archiving activities and for ensuring that these activities are cost effective.

You will maintain an up-to-date knowledge of clinical research archiving and appropriate legislation.

The core function of the R&I Office at The Christie is to provide an efficient support service for the research delivery teams and both internal and external researchers enabling the Trust to deliver its research ambitions. The R&I Office protects patients and researchers at every stage of the study journey and acts as a central coordinating function for both hosted and Christie sponsored research from grant application to archiving.

As a member of the R&I Office, you will become part of a professional, supportive and caring team. There will be opportunities for broadening your knowledge of the research process and for career development.

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 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.
1. DUTIES AND RESPONSIBILITIES

• Act as trust wide point of contact for all archiving queries from internal and external users, providing clear guidelines and advice on all aspects of study documentation archiving.
• To ensure that all electronic and paper records relating to archiving are maintained, so that all materials are fully traceable and in-keeping with GCP and MHRA standards (where applicable).
• Support the collation of study information by compiling study documentation e.g. CRFs, REC/HRA/MHRA applications and R&I/sponsor correspondence.
• Ensure coordination and collection of study information and prepare as per trust standard operating procedures for shipping off site in a manner that the integrity of documents are maintained.
• Arrange shipment of study information to an offsite facility.
• Audit offsite storage facility as required to ensure study documents are stored to the applicable standards.
• Ensure timely destruction and retention of study documentation. Building relationships and liaising with sponsor and investigators about deadlines for such activity.
• Retrieve archived study documents when requested by the research teams and/or other authorised staff.
• Responsible for budget management for all the archiving activities ensuring activities are cost effective. Monthly receipting of archiving invoices to ensure all activities are captured correctly.
• Provide judgement on information and facts generated during the archival process, some of which will require analysis.
• Responsible for the collation of monthly archiving figures which are reported at regular team meetings.
• On-going knowledge of clinical research archiving and appropriate legislation as specialist knowledge required for problem solving.
• Work collaboratively to implement any relevant changes and disseminate information as required to the research community.
• Supervise junior members of staff with archiving, if appropriate.
• Responsible for coordinating with external stakeholders to ensure Christie- sponsored research documents are archived as per GCP standard, legislation and trust policies.
• Ensure that office supplies are adequate, ordered and obtained for the smooth running of the office including sourcing alternatives, as
• Responsible for maintaining stock levels for archive materials, and ensuring these are available to any research team embarking on the archiving process.
• Support of the organisation of GCP training, maintaining records of attendance and being first point of contact for all queries relating to GCP training.
• Maintain and report GCP training compliance for all individuals within the Research & Innovation Division of the trust.
• Support the co-ordination of multiple aspects of study activity, including liaison with R&I, research teams, trial administration staff, research governance and external regulatory bodies.
• Support the R&I Office in all areas of R&I administration as required.
• Maintain own professional development and identify learning needs and opportunities.
• Other duties as requested as appropriate

• Work closely with the Senior Research Management Team to contribute towards development of new SOPs and working procedures relating to archiving.
• Be pro-active in providing feedback on working practices within the Research & Innovation Division and suggest new ways of working
• The post holder is expected to use initiative and be able to work independently. They are also expected to plan and organise their own time and workload activity with prioritisation, referring to senior managers as necessary
• The post holder is guided by relevant protocols and SOPs, and expected to exercise judgement and interpretation outside these areas.

• Work with Microsoft Office programmes, requiring standard keyboard skills
• There is an on-going requirement to exert light to medium physical effort in this role.

• Prolonged concentration is regularly required e.g. when checking through study documentation and entering data electronically
• Occasional exposure to distressed circumstances as study patients are commonly suffering from terminal illnesses

• Regular use of VDU for electronic communication and data management.