Senior Clinical Research Practitioner

Job summary

We're looking for a full time Band 5 Clinical Research Practitioner to coordinate and deliver clinical research studies at The Christie NHS Foundation Trust.

We are looking for a highly motivated and enthusiastic individual who can contribute to the development of clinical research for people with cancer within the Rare Tumours Research Team. Our team work with Teenagers and Young Adults (TYA) and an interest in TYA would be an advantage. We look after patients with rare cancers including patients with CNS tumours and Sarcomas.

We have an extensive portfolio of trials, NIHR academic and commercial clinical trials, covering these disease groups. The role of the CRP will involve recruiting patients to these clinical trials, obtaining informed consent where appropriate, supporting patients enrolled in clinical trials, and ensuring study interventions are completed according to Good Clinical Practice (GCP) and Trust standards.

You will be working within a supportive team of experienced clinical research nurses and the clinical trial administration team.

Main duties of the job

The post will involve coordinating a portfolio of research studies across different specialties within the Trust and is ideal for individuals with an interest in TYA and experience of working in a busy clinical / research environment who wish to further develop their skills and experience.

We are seeking candidates with experience in working in clinical research in the NHS that can demonstrate knowledge of Good Clinical Practice and clinical skills, such as phlebotomy. Strong communication and organisational skills are essential, and a flexible working approach is a key element to this role.

About us

The Christie is one of Europe's leading cancer centres, treating over 60,000 patients a year. We are based in Manchester and serve a population of million across Greater Manchester & Cheshire, but as a national specialist around 15% patients are referred to us from other parts of the country.

We provide radiotherapy through one of the largest radiotherapy departments in the world; chemotherapy on site and through 14 other hospitals; highly specialist surgery for complex and rare cancer; and a wide range of support and diagnostic services. We are also an international leader in research, with world first breakthroughs for over 100 years.

We run one of the largest early clinical trial units in Europe with over 300 trials every year. Cancer research in Manchester, most of which is undertaken on the Christie site, has been officially ranked the best in the UK.

Job description

Job responsibilities

DUTIES AND RESPONSIBILITIES:

The specific responsibilities will depend on the requirements of each team, but may include:

Clinical Research Delivery & Co-ordination

To act as a primary contact point for the clinical trial patients for defined clinical trials and act as adviser to other health care professionals.

Interview, recruit, take informed consent and support patients and carers in clinical trials/studies. This involves educating patients on the trials involved, explaining the advantages and disadvantages of taking part in trials, whilst always remaining unbiased.

Ensure the provision of optimal patient care by alerting appropriate clinical colleagues when referral to other members of the MDT may be required.

Be responsible for the safe and accurate collection of research samples and data, through clinical procedures such as venepuncture, and history taking, standard observations and other assessments including questionnaires, rated scales, qualitative interviewing as required by the protocol.

Centrifuge, process, track and ship samples in line with protocol requirements

Work with the clinical trials team and investigators to develop strategies to overcome barriers to recruitment and to solve other problems relating to specific studies

Work with other departments within the Trust to ensure that trial specific investigations and procedures are undertaken as required by the trial protocol, to establish eligibility and safety of patients within clinical trials.

Act as a key point of contact with the R&D core team, study sponsors, clinical research organisations and specific research teams.

Manage the set up and initiation of allocated clinical trials within assigned Clinical Research Teams.

Where delegated to do so, set up and maintain study site files in accordance with GCP and Trust SOPs.

Understand and deliver protocols in accordance with regulatory requirements

Ensure all clinical trial activities are recorded in appropriate systems in a timely manner.

Maintain adequate patient records and ensure all relevant information is documented in the patients notes.

Oversee and complete case report forms and participate in monitoring visits as per sponsor requirements.

Ensure that all documents are archived in the appropriate way by following the Trusts archiving guidelines.

Undertake general administrative tasks as delegated by managerial representatives from the R&D division to contribute to the smooth running of the patient recruitment teams.

Attend research team meetings to maintain an overview of team activity.

Awareness of trial specific, regional and national targets. Identify and implement strategies for recruiting patients to clinical trials ensuring that targets for patient recruitment are delivered.

Clinical Service Responsibilities

Demonstrate awareness of divisional and trust strategic objectives including performance indicators and metrics.

Escalation of governance issues impacting on delivery of job purpose.

Participate in monitoring and audit activities within research team

Management

Provide induction support and training to new and existing clinical trials staff, including development of training sessions and guidance documents.

Encourage the sharing of best practice and dissemination of information through regular structured meetings with all trials administration staff.

Assist with metric tracking for performance indicators including mandatory training requirements, divisional key performance indicators ( time to recruiting first patient from NHS permission, patient recruitment to time and target), amendment timelines and divisional absences.

PERSONAL AND PEOPLE DEVELOPMENT

Maintain professional development whilst evaluating own specialist knowledge with assistance from their assigned line manager to satisfy the NHS Knowledge and Skills Framework.

Participate in and deliver Trust-wide education programmes and study days, regional and national meetings and research seminars as appropriate.

PHYSICAL, MENTAL AND EMOTIONAL EFFORT

Long periods of time spent using keyboard to input information and use of VDU for electronic communication.

Prolonged concentration is regularly required ( when checking through trial documentation and entering data into spreadsheets).

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

Person Specification

Qualifications

Essential

Scientific Degree or relevant experience in scientific and medical research

Desirable

Post Graduate certificate in Clinical Research or other relevant post graduate qualification/experience

Experience

Essential

Experience in clinical trials administration, data management involving clinical trials or project coordination or Experience of working within a health care system and within a multidisciplinary clinical team NHS experience

Desirable

Collection and processing of bloods Experience working in oncology Experience dealing with queries from patients and their families regarding sensitive issues

Skills

Essential

Excellent organisational skills Excellent interpersonal skills Good oral and written communication skills IT literate Attention to detail

Desirable

Advanced use of spreadsheets Ability to create PowerPoint presentations and other Microsoft office applications Ability and willingness to train in clinical skills

Knowledge

Essential

Understanding of clinical research GCP guidelines/EU directives Knowledge of clinical governance Knowledge of patient information systems

Desirable

Knowledge of medical terminology Knowledge of oncology

Values

Essential

Ability to demonstrate the organisational values and behaviours

Other

Essential

Tactful and diplomatic Flexible Conscientious and hardworking Ability to work unsupervised or as part of a team Ability to work to tight and/or unexpected deadlines

Desirable

Evidence of CPD Evidence of achievement under pressure

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