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Job Description
As the sole supplier to the LTHT for all their contract non medical/non clinical staff, we are currently recruiting for Clinical Trials Assistant to work in the LS9 area of Leeds. The role is working 9-5, Mon-Fri, with the right candidate starting ASAP.
The post holder will be working within a busy and expanding Clinical Trials department based in the St James’s Institute of Oncology, Bexley Wing. The department currently participates in over one hundred clinical trials covering a range of solid tumours. The majority of these trials are multi-centre Phase II and Phase II studies, although there is a growing Phase I department conducting first in man and very early clinical trials. Clinical trials support is provided to 60 consultant staff and the number of patients in trials can range from 2 to 50+ and the post holder is expected to meet all reporting procedure timescales. The post holder will have responsibility for multiple disease sites which will vary according to each specific portfolio.
The post holder will be expected to have attained a level of administrative experience proportionate to the competencies of the post, and experience of caring for patients in either an oncology or research setting. Knowledge of research methodologies and clinical trials experience would be a distinct advantage, although this is not essential. The post holder should be able to work unsupervised using his/her own initiative and prioritise and manage their time effectively. The post holder must be able to deal with the public and staff in a pleasant and polite manner at all times and possess a professional attitude to work, be diplomatic and able to work calmly under pressure.
Main duties and responsibilities:
1.1 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
1.2 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.
2 Team Working;
2.1 To ensure that all members of the multidisciplinary team are aware of the current trials portfolio.
2.2 To provide feedback to Site Specific Research Groups (SSRGs) and MDT members on issues relating to recruitment, protocol amendments and trial results.
2.3 To disseminate information from the Business Development Manager/ Area Manager (Section of Oncology and Clinical Trials) to the local research teams.
2.4 The post holder will demonstrate the ability to manage their own administrative case-load, working as part of the multidisciplinary team.
2.5 In conjunction with all members of the cancer clinical trials team and appropriate healthcare professionals, develop a cohesive and flexible team working environment across the service.
3. Administration;
3.1 To assist the Area Manager (Section of Oncology and Clinical Trials) and local research teams in the formulation of documentation in preparation for ethical submission.
3.2 To be responsible for the collection and collation of trial data and completion of trial documentation in accordance with trial protocols.
3.3 To ensure that all toxicity, quality of life assessments are completed in line with protocol requests. This may involve undertaking telephone assessments.
3.4 To ensure that all trial data is submitted to the study sponsor within the specified time constraints.
3.5 To manage and respond to any data queries received.
3.6 To maintain a monthly accrual list of all studies and distribute among the relevant members of the MDTs and SSRGs.
3.7 To report monthly to the Business Development Manager accrual data on all patients recruited into all oncology portfolio studies highlighting local activities that might impact on achievement of the Clinical Trial Unit’s aims.
.1To contribute to the development of the oncology portfolio of trials.
4.2 To help implement local and national quality standards, professional standards, recommendations and guidelines from national reports.
4.3 The post holder will adhere to the Data Protection Act and maintain patient confidentiality at all times.
4.4 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.
4.5 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.
4.6 The post holder will be expected to represent the Oncology Clinical Trials Unit in a professional manner at meetings and events.
4.7 The post holder will be expected to work to ICH GCP guidelines at all times.
4.8 As a new post holder, an induction and training programme will be provided for key aspects of this role, however the post holder will be expected to take advantage of opportunities to attend meetings and workshops to enhance their knowledge of Clinical Research and Cancer Care.
4.9 The staff member will 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.
4.10 To undertake any other duties deemed appropriate to the role.
If you believe that you have the correct skills set for the role then do not hesitate to apply by using the online facility available.
Please note that, due to the amount of applications expected, only successful candidates will be contacted.
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