Clinical Research Practitioner Oncology

Job description

Job responsibilities

Ward/Department staff, Principal Investigators, Patients and their relatives/ carers/ significant other, Staff in other departments across Worcestershire Acute Hospitals NHS Trust, Pharmacy, Pathology and Radiology, Research & Development Directorate Team, including research delivery staff, Herefordshire and Worcestershire Research Consortium, Clinical Trials Units/Academic Sponsors, Pharmaceutical companies/Clinical Research Organisations, West Midlands Clinical Research Network

Risk Assessment :

This post involves manual handling activities, exposure to bodily fluids and exposure to high noise levels. It may also involve exposure to challenging behaviour. The post requires standard keyboard use, sitting for periods at a computer and screen, travel between Trust sites.

Job Purpose

We are committed to supporting research that is relevant and accessible to our patients. Through clinical research we can assess the efficacy of new medication, diagnostics, and treatment regimes. This helps to build the evidence for new approaches to improve patient care.

This role will be a key part of the research delivery team providing dedicated clinical trials support to patients at Worcestershire Acute Hospitals NHS Trust. Working closely with clinical colleagues, you will provide support for day-to-day research delivery activities, ensuring the requirements of study protocols and legislation are met.

The department is involved in a range of clinical studies including pioneering Covid-19 research, life changing oncology and haematology trials, internationally recognised midwifery, renal and surgical studies, and many more. You will have the opportunity to get involved with a range of these, having direct contact with patients, carers and staff.You will be based within the oncology team and be responsible for working across the sites and may extend outside of the oncology specialty.

The postholder is responsible for assessing and managing the care pathways for patients and carers participating in clinical research within oncology. This will involve establishing study feasibility, pre-trial set-up activities, recruitment of participants, education and monitoring of research patients and the collection and documentation of accurate data. The role involves following research protocols and local, national and international research regulations. The post holder will work collaboratively with all research stakeholders (e.g. Principal Investigators, clinicians, academics and Research Networks) in the management of their own caseload and the supervision of junior staff.

The postholder would be expected to undertake appropriate training to work towards Accreditation on the Clinical Research Practitioner Register.

Key Duties:

Clinical

• To identify eligible patients for studies by, reviewing notes, use software and attending appropriate clinics

• Interview, consent, recruit, support and monitor patients in clinical trials and research studies. This involves explaining complex information at potentially distressing times.

• To ensure that trial specific investigations are undertaken as required by the research protocol in order to establish eligibility and safety to enter the trial.

• Arrange investigations required to establish eligibility and safety for trial entry

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

• Provide continuity of care for patients and their carers throughout the trial programme.

• Provide non-clinical advice and support as appropriate.

• To provide ongoing information, education and support to patients and carers regarding clinical trials.

• To undertake venepuncture and the collection of blood and other samples as required by the trial protocol and in accordance with local procedures.

• To maintain accurate, comprehensive documentation of patient events in clinical records as required

• Collect and enter data for patients in treatment and non-treatment trials

• To report clinical incidents and any areas of concern to line manager as appropriate

• Administer questionnaires / diaries to patients, provide instruction and subsequent collection

• Review patient records, identify source data, accurately record a range of data both electronically and in paper format, in a timely manner.

• Perform consistency checks on data collected for each patient throughout their trial journey. Resolve inconsistencies and respond to data queries.

• Responsible for identifying serious adverse events and adverse events (either from communicating with patients, carers or clinical colleagues, or from investigating medical records) and reporting these within set deadlines.

• Design forms to capture source data; the forms will be specific to each trial but will have an agreed format

• Design and maintain spreadsheets / databases to track patient journeys in trials. The spreadsheets / databases may be used by all members of the research team as an information resource.

• Responsible for ensuring trial subjects adhere to trial protocols

• Ensure that trials are conducted according to the Research Governance and legislative frameworks

• Maintain clinical trial site files to ensure a complete audit trail for trials.

• Assist in the review of trial protocols and identify resource implications for the site.

• Assist with trial set up, liaising with clinicians, supporting departments, other healthcare professionals and trials units, as required

• Working with supporting departments such as Pharmacy, Radiology, Pathology to facilitate the timely set up and smooth running of clinical trials

Management

• Disseminate information on new trials

• Assist in the set-up of clinical trials and ongoing documentation associated with clinical trials such as amendments

• Assist in review of, and adhere to local Standard Operating Procedures for research

• Communicate regularly and effectively: with team colleagues, Principal Investigator, R&I, supporting departments, trials unit staff, Research Delivery Network, other trust staff and others as required to ensure that research studies run to time and target and that teams work together and are kept informed.

• Provide cover for research colleagues in their absence.

• Assist in the planning and delivery of any meetings that help facilitate the smooth running of the research portfolio and team.

Professional and Educational Responsibilities

• Act as a resource for colleagues in relation to clinical trials

• To maintain an up-to-date knowledge of clinical research and relevant clinical specialties

• Actively engage in personal development, contributing to own performance review and personal development plan.

• Work towards Clinical Research Practitioner Accreditation

• To maintain links with other clinical research staff across the Trust and RDN West Midlands to share knowledge and to provide mutual support.

• Attend national meetings in relation to clinical research as appropriate and agreed with local training link

• Mentor new staff and provide training in own discipline as required.

• Liase with departments and wards at the site/s, in order to promote a good working environment, integration of research, and maintain open channels of communication.

• Liaise with Clinical Trials Units across the UK

General duties:

• The post-holder would be based at Worcestershire Royal Hospital, with regular travel to other sites across the trust

• To ensure that the views of research participants are effectively sought, channelled and acted upon.

• To ensure the efficient actioning of the complaints procedure in accordance with the Trust policy in conjunction with the Lead Research Nurse and Head of Research Operations.

• To understand and adhere to Trust policies and procedures.

• The purpose of this post should remain constant, but the duties and responsibilities may vary over time within the overall role and level of the post. The post holder may from time to time be asked to undertake other reasonable duties. Any such changes will be made in discussion with the post holder in the light of service needs.

Vision and Values:

The Trust aims to provide local services for local people. It has developed its vision to reflect this commitment.

To continue to be the major provider of acute/specialist services for the people of Worcestershire (and wider) with a strong reputation for providing outstanding, high quality, reliable, accessible and integrated healthcare for local people

Driving this commitment are the Trust-wide signature behaviours:

• Do what we say we will do

• No Delays, every day

• We listen, we learn, we lead

• Work together, celebrate together

Person Specification

Skills/Knowledge

Essential

• Apply practice in line with Good Clinical Practice Able to communicate complex information to patients and their carers. Demonstrate the interpersonal skills to communicate with compassion and empathy at times that may be sensitive and challenging Able to implement a complex research protocol Able to maintain a safe working environment in which research care is delivered Understand the quality assurance processes within research that protect participant confidentiality, rights and data integrity Contribute to ongoing Quality Improvement within the team Working medical knowledge terminology

Desirable

• Good theoretical knowledge of oncology Understanding of research governance and legislation

Experience

Essential

• Experience of working in a clinical or research environment Experience of using MS platforms (Teams, Excel, Word, Outlook)

Desirable

• Clinical research experience Data management experience Experience using NHS digital systems Phlebotomy skills Experience of communicating directly with patients on a regular basis

Qualifications

Essential

• Undergraduate degree

Desirable

• CRP Accreditation GCP Certificate Informed consent training

Personal Qualities

Essential

• Ability to act as an autonomous and accountable professional Able to exercise own judgement within the boundaries of the role Able to practice safely and effectively within the scope of professional competence Able to maintain fitness to practice and behaviours that support professionalism Understand the impact of culture, equality and diversity on clinical research study participants and the need to safeguard and act in a non-discriminatory manner Ability to communicate effectively across a multidisciplinary team Practice within the legal and ethical boundaries of your profession as a Clinical Research Practitioner Ability to work autonomously using own initiative, as a member of a small team Well-developed organisational skills and ability to multi-task Flexibility to ensure achievement of objectives within constantly changing environments Ability to work flexible hours as required to meet the service needs Willingness to work towards CRP accreditation

Desirable

• Understanding of complex issues facing Research Departments and ability to work with individuals and departments to address issues

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Employer details

Employer name

Worcestershire Acute Hospitals NHS Trust

Address

Charles Hastings Way

Worcester

Worcestershire

WR5 1DD

Employer's website

https://www.worcsacute.nhs.uk/ (Opens in a new tab)