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TITLE OF POST: Clinical Trials Assistant

GRADE/SALARY: Band 3 (Fixed term for 1 year initially, or potential secondment opportunity)

LOCATION: BRI

DEPARTMENT: Research & Development

HOURS: 37.5HOURS PER WEEK

BRIEF DESCRIPTION OF POST:
This is an exciting new post for an individual with previous administrative and/or healthcare experience to work on a range of clinical research trials in the Maternal and Child Health Research Team and with the potential to work with different specialities across the Trust.

Working mainly with the Maternal and Child Health Research Team within Bradford Teaching Hospitals NHS Foundation Trust you will be responsible for providing administrative support ensuring accurate data collection and documentation throughout the patient’s participation in the trial. The conduct and delivery of high quality clinically based research helps improve the treatment of patients in Bradford.

You will work mainly with the Maternal and Child Health Research Team to help provide support for clinical trial participants ensuring a high quality research service. The post holder will be expected to interact with patients and their families in relation to the requirements of the clinical trials and be able to work without supervision at times.

You will work mainly with the Maternal and Child Health Research Team to help provide support for clinical trial participants ensuring a high quality research service. The post holder will be expected to interact with patients and their families in relation to the requirements of the clinical trials and be able to work without supervision at times.

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 teams managing your time effectively. You will be proficient with Microsoft Office applications (Word, Excel etc.).

Additional/useful: Previous clinical trials experience and GCP training

Enquiries to: Kari Swettenham, Senior Research Midwife

Email [email protected]

Tel 01274 364506 or Mobile 07508 050297

We can offer staff gymnasiums on both hospital sites, subsidised 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.

• 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.

• To assist the Senior Research Midwives and Research Midwives and Nurse 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.

• 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.