Job Description

Closing Date:

11.08.25

Shortlisting to take place after closing date:

commencing 11.08.25



Interview expected to take place 25 .08.25



This is an exciting opportunity to join the Ophthalmology and Gastroenterology Research Team .The post will be based in the NIHR Commercial Research Delivery Centre. The successful candidate will support to deliver an extensive portfolio of clinical trials within Ophthalmology and Gastroenterology. The role requires providing a full administrative service, including maintaining study specific master site files and trial documentation. collating and submitting trial data, both on paper and electronically, submitting clinical trial amendments and compiling reports on trial progress. For the right applicant this post offers a position with varied duties and the opportunity to acquire further knowledge and experience within clinical research. You will derive satisfaction being part of a multi-disciplinary team that is making a real contribution to clinical research and patient benefit

TITLE OF POST:

Clinical Trials Assistant

GRADE/SALARY:

Band 3 (Fixed term for 12 months initially, or potential secondment opportunity)

LOCATION:

BRI

DEPARTMENT:

Research & Development

HOURS:

37.5 HOURS PER WEEK

BRIEF DESCRIPTION OF POST:

The Clinical Trials Administrator will ensure the smooth set up and day to day operation of clinical trials by assisting the research team with various aspects of clinical trial delivery.



Working closely with the Research Sisters, the post holder will provide full administrative assistance t and will assist in the facilitation of high-quality research, providing efficient and accurate data entry on to trial databases, answering queries in a timely fashion and assisting with on site monitoring. The role also includes assisting in the running of the clean room and attending Endoscopy Suite to facilitate giving trial treatments, timely collection of relevant data and collecting and preparing blood/bodily fluid/tissue samples in accordance with trial protocols.



.

SKILL/QUALIFICATION REQUIRED:

The post holder must be educated to GCSE level and NVQ level 3 in Business Administration or Healthcare (or equivalent experience). Knowledge and understanding of research methodologies is desirable.



You must have an ability to work on own initiative and have the ability to work with a number of different staff managing your time effectively. You will be proficient with Microsoft Office applications (Word, Excel etc.).

Additional/useful:

Previous clinical trials experience and GCP training



For further information or to arrange a tour of the facilities please contact:



Nicola Hawes - Senior Research Sister 07834471064



Sarah Moss - Research Sister 01274 27 6377



We can offer staff gymnasiums on both hospital sites, subsidized restaurants, final salary pension scheme including life assurance cover and childcare facilities.



PRIMARY DUTIES & AREAS OF RESPONSIBILITY



Patient support



To assist in the evaluation of patient eligibility, in liaison with other appropriate health care professionals for clinical trial entry, involving the co-ordination of pre-study tests, obtaining results/X-Rays and arranging appropriate appointments as per clinical trial protocols To assist the co-ordination of the patient's journey through the clinical trial protocol e.g. requisition and organisation of any necessary investigations, procurement of patient notes and X-Rays.

Team Working



To ensure that all members of the multidisciplinary team are aware of the current trials portfolio. To assist with providing feedback to specific research teams and MDT members on issues relating to recruitment, protocol amendments and trial results. To disseminate information from the NIHR, trial co-ordinators to the local research teams The post holder will demonstrate the ability to manage their own administrative case-load, working as part of the multidisciplinary team. In conjunction with all members of the clinical trial teams and appropriate healthcare professionals, develop a cohesive and flexible team working environment across the service.

Administration



To assist the Senior Research Nurses in the formulation of documentation in preparation for ethical submission. To be responsible for the collection and collation of trial data and completion of trial documentation in accordance with trial protocols. To ensure that all toxicity, quality of life assessments are completed in line with protocol requests. This may involve undertaking telephone assessments. To ensure that all trial data is submitted to the study sponsor within the specified time constraints. To manage and respond to any data queries received as directed by Research Team. To maintain a monthly accrual list of all studies and distribute among the relevant members of the MDTs To report accrual data on all patients recruited onto the recruitment data base e.g. EDGE.

General



To provide administrative support for research midwives and nurse as required by the research teams across the Trust e.g. send letters and faxes, collecting and returning medical notes, taking and disseminating minutes of meetings To help implement local and national quality standards, professional standards, recommendations and guidelines from national reports. Ensure that office and clinic supplies are adequately ordered and stored for the smooth running of the trials. The post holder will adhere to the Data Protection Act and maintain patient confidentiality at all times. The post holder will act in a professional manner at all times when dealing with patients, their relatives and representatives from both external and internal sources. The post holder will deal with telephone enquiries from staff, patients and carers ensuring that appropriate personnel are informed in order for actions to be taken. The post holder will be expected to represent the Trust in a professional manner at meetings and events, as required. The post holder will be expected to work to ICH/GCP guidelines at all times. As a new post holder, an induction and training programme will be provided for key aspects of this role. The post holder will be expected to take advantage of opportunities to attend meetings and workshops to enhance their knowledge of Clinical Research. Ensure that (s)he follows the Trust's hospital infection prevention and control policies and procedures to protect patients, staff and visitors from healthcare-associated infections. He or she will ensure that (s)he performs the correct hand hygiene procedures, when entering clinical areas. * Undertake any other duties appropriate to the role.