Clinical Study Coordinator - Advanced Therapies Facility - 39964 - Grade 6

Position Details

Human Biomaterials Resource Centre

Location: Advanced Therapies Facility, University of Birmingham, Edgbaston, Birmingham UK

As this vacancy has limited funding the maximum salary that can be offered is Grade 6, salary £27,924 per annum.

Grade 6

Full Time Fixed Term Contract up to 31.07.2021

Closing Date: 16th December 2021

Job Summary

The role of the post-holder is to support the effective and efficient delivery of ongoing clinical research projects being supported by the Human Biomaterials Resource Centre (HBRC), which involve the collection of samples from human participants. This will involve the identification and recruitment of appropriate patients in a variety of clinic settings (and on occasion, health volunteers), obtaining informed consent, sample collection and processing according to project protocols and HBRC Standard Operating Procedures, and completion of the necessary records and electronic tracking logs.

Some of the larger projects will require a significant amount of coordination and oversight in terms of patient accrual, recruitment and sample collection, transfer and tracking across a number of local participating NHS sites. The post-holder will require strong organisational skills and good communication skills to ensure effective interaction with patients, clinicians, surgeons, and the basic science and clinical research communities.

The HBRC is a Human Tissue Authority (HTA) licensed, ethically approved human sample biorepository situated at the University of Birmingham which is dedicated to the collection and storage of appropriately consented, quality-assured biomaterials for distribution to biomedical research groups both in academia and industry.

The facility also provides tissue-based histological services, and hosts valuable sample collections. The role of the HBRC is to facilitate the funding and expedition of high quality clinical research in Birmingham. Ultimately the HBRC will be a valuable resource, not only for local scientists, but also for researchers throughout the

UK and EU, including the commercial sector. The HBRC exists in a purpose-built fully-equipped facility set up through the regional development agency Advantage West Midlands Science City Translational Medicine Programme, with investment from University Hospital Birmingham NHS Foundation Trust, the University of Birmingham and the MRC.

Main Duties

• Identification of eligible patients for a variety of projects/trials using different soucrce of information such as clinic and surgical lists, patient health records/NHS Trust information systems and records from MDT meeting. The post holder will then be required to determine the best point in the patient pathway to approach a patient in order to obtain informed consent, to supply the relevant information, and to have sufficient knowledge of the research project to be able to answer any questions arising from the initial patient/donor interview. He/she will be expected to work according to the requirements of the UK Policy Framework for Health and Social Care Research, to Caldecott Principles, and in a manner compliant with the Human Tissue Act 2004.
• Attendance at clinics/operating theatres in order to collect the appropriate samples. The person appointed will perform this task with autonomy and in an integrated way with clinical staff to ensure minimal disruption to the patient treatment pathway. SOPs will be followed for collection, transfer and any subsequent processing of samples within the HBRC to ensure sample integrity. The entire process will be Human Tissue Act compliant and will be carried out in accordance with Good Clinical Practice and local Health and Safety procedures.
• Keeping accurate records at all stages, from initial patient identification to ultimate sample storage or transfer to research projects. Maintenance of sample tracking and patient databases within the HBRC.
• To take responsibility for a number of projects to ensure the smooth and timely consent and collection of samples according to the project protocol. Liaison with several local NHS sites to coordinate the collection of consent, samples and subsequent transfer to the HBRC. Attendance at relevant prject meetings both locally and away. Sharing best practice and highlighting project problems.
• To contribute to the Quality Management System within the HBRC. This will involve the writing and review of SOPs, contribution to, and facilitation of internal/external audit procedures and to regulatory inspections.
• Any other duties commensurate with the grade and skill base of the post holder as directed by the HBRC General Manager.

It is a requirement for both HTA and GCP compliance that all procedures within the HBRC are carried out according to strict Standard Operating Procedures (SOPs) which comply with all current regulations, legislation and governance arrangements surrounding the research use of human tissues and handling of clinical trial samples, and with Health and Safety regulations.

Person Specification

• Experience of working within a regulated quality-controlled biomedical environment or tissue bank.
• Phlebotomy trained
• Familiar with technologies associated with handling and processing human samples
• Practical experience of working within the NHS environment, and a good understanding of the ethical and regulatory issues surrounding human sample collection and use for research e.g. Human Tissue Act 2004, UK Policy Framework for Health and Social Care Research, Good Clinical Practice, Data Protection Act/GDPR.
• Familiar with health and safety requirements/policies relating to biological samples
• Must be able to use initiative and work independently
• Must be able to prioritise tasks in order to ensure continuity of sample collection
• Good communication, interpersonal and organisational skills
• The ability to anticipate and identify any problems and weaknesses with procedures, and to develop and implement improvements, new approaches or systems
• Attention to detail and ability to maintain accurate records
• Courteous and patient
• Good level of basic computing and technical skills
• Positive service attitude

Informal enquires to Dr Gareth Bicknell, email: g.bicknell@bham.ac.uk

Further particulars can be found here: http://www.download.bham.ac.uk/vacancies/jd/MDSFPs.pdf

Valuing excellence, sustaining investment

We value diversity and inclusion at the University of Birmingham and welcome applications from all sections of the community and are open to discussions around all forms of flexible working