Detailed job description and main responsibilities

DUTIES AND RESPONSIBILITIES

1.1.         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.

1.2.         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).

1.3.         Support the collation of study information by compiling study documentation e.g. CRFs, REC/HRA/MHRA applications and R&I/sponsor correspondence.

1.4.         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.

1.5.         Arrange shipment of study information to an offsite facility.

1.6.         Audit offsite storage facility as required to ensure study documents are stored to the applicable standards.

1.7.         Ensure timely destruction and retention of study documentation. Building relationships and liaising with sponsor and investigators about deadlines for such activity.

1.8.         Retrieve archived study documents when requested by the research teams and/or other authorised staff.

1.9.         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.

1.10.      Provide judgement on information and facts generated during the archival process, some of which will require analysis.

1.11.      Responsible for the collation of monthly archiving figures which are reported at regular team meetings.

1.12.      On-going knowledge of clinical research archiving and appropriate legislation as specialist knowledge required for problem solving.

1.13.      Work collaboratively to implement any relevant changes and disseminate information as required to the research community.

1.14.      Supervise junior members of staff with archiving, if appropriate.

1.15.      Responsible for coordinating with external stakeholders to ensure Christie- sponsored research documents are archived as per GCP standard, legislation and trust policies.

1.16.      Ensure that office supplies are adequate, ordered and obtained for the smooth running of the office including sourcing alternatives, as  required.

1.17.      Responsible for maintaining stock levels for archive materials, and ensuring these are available to any research team embarking on the archiving process.

1.18.      Support of the organisation of GCP training, maintaining records of attendance and being first point of contact for all queries relating to GCP training.

1.19.      Maintain and report GCP training compliance for all individuals within the Research & Innovation Division of the trust.

1.20.      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.

1.21.      Support the R&I Office in all areas of R&I administration as required.

1.22.      Maintain own professional development and identify learning needs and opportunities.

1.23.      Other duties as requested as appropriate.

2.        WORKING PRACTICES

2.1.         Work closely with the Senior Research Management Team to contribute towards development of new SOPs and working procedures relating to archiving.

2.2.         Be pro-active in providing feedback on working practices within the Research & Innovation Division and suggest new ways of working.

2.3.         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.

2.4.         The post holder is guided by relevant protocols and SOPs, and expected to exercise judgement and interpretation outside these areas.

3.          PHYSICAL SKILLS

3.1          Work with Microsoft Office programmes, requiring standard keyboard skills.

3.2          There is an on-going requirement to exert light to medium physical effort in this role.

4.     PHYSICAL, EMOTIONAL AND MENTAL EFFORT

4.1          Prolonged concentration is regularly required e.g. when checking through study documentation and entering data electronically.

4.2          Occasional exposure to distressed circumstances as study patients are commonly suffering from terminal illnesses.

5.     WORKING CONDITIONS

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

This job description is not meant to be finite and may be subject to change following discussion and agreement with the post holder. Similarly the post holder may be requested to undertake such other duties not mentioned in the job description which are commensurate with the grade.