Clinical Research Practitioner

Job overview

We are looking to appoint a Research Practitioner (Band 4) in the Lung Research team within The Christie NHS Foundation Trust. The research teams form part of the Research and Innovation division and are made up of a multi-disciplinary group of staff who are dedicated to cancer research and treatment.

We are seeking an enthusiastic, motivated, and experienced individual who will be responsible for assisting the research nurses, consultants and trial management team with the delivery of clinical research projects and clinical trials. We are looking for an individual who is able to demonstrate work experience in data management involving clinical trials, good understanding of clinical research, GCP and clinical trial governance. Strong candidates will have excellent organisation and communication skills, work well both in a team and using their own initiative.

Applicants should meet all the essential criteria on the job description as a minimum. We are looking for a candidate with good organisational and communication skills, with the ability to multi-task. Due to the vital nature of our work and the impact on patients and the research community, attention to detail is an essential skill.

An informal conversation to discuss the post is highly recommended.

Main duties of the job

The post-holder will work across the clinical and administrative areas of the Lung Research Team. In clinical areas, they will work under the supervision and delegation of clinical research nurses and investigators, providing patient support within the limits of their competence.

Duties may include collecting biological samples, recording observations and data, and completing quality-of-life questionnaires with trial participants. In administrative areas, they will work with trial coordinators and research managers to support a portfolio of clinical projects. Responsibilities include entering visit data, responding to trial queries, maintaining trial records and essential documents, supporting invoicing, liaising with Research and Innovation colleagues and pharmaceutical contacts, and assisting with wider administrative tasks.

The post-holder will participate fully in personal development and review and should hold, or be working towards, the National Care Certificate.

Full training and further development opportunities are provided. The Lung team delivers early-phase, biomarker, real-world data, radiotherapy and biobanking studies.

This challenging and rewarding role offers the opportunity to join a friendly, hard-working team committed to research, high-quality patient care and improved cancer outcomes.

Detailed job description and main responsibilities

DUTIES AND RESPONSIBILITIES:

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

Clinical

• Provide clinical care for research participants, as delegated by PIs and research nurses, within the boundaries of own knowledge, competence and skill level.
• Ensure that all research is undertaken according to Good Clinical Practice (GCP), standard operating procedures (SOPs) and Trust policies.
• Planning and organising day- to-day research and other activities
• Conduct delegated data collection with participants, such as questionnaires and interviews.
• Collection of biological samples as required for the clinical protocol, this may include blood, urine, sputum etc.
• Preparation of sampling kits as described in study laboratory manuals, maintaining laboratory stock and shipping & tracking of research samples.
• Undertake research-related activities as required such as clinical observations and NEWS2, blood glucose monitoring, blood sampling (venepuncture and other venous access), PK sampling, cannulation and ECGs.
• Attend individual project meetings as required.
• Contribute to clinical and research governance processes, including adverse event and incident reporting, supporting any investigations.
• Understand and deliver care in accordance with regulatory approved clinical research protocols.
• Ensure all clinical activities are recorded in appropriate systems in a timely manner.
• Evening and weekend shifts may occasionally be required to meet the clinical needs of the service

Research

• Act as a point of contact for the core Research and Innovation team, study sponsors, clinical research organisations and specific research teams, communicating directly with them regarding data queries, monitoring visits and other enquiries relevant to trial set up and general trial conduct.
• Maintain investigator site files and essential documentation in accordance with ICH-GCP and Trust SOPs to ensure they are kept inspection ready at all times.
• Process trial amendment submissions in accordance with ICH-GCP and Trust SOPs and timelines.
• Complete case report forms as per sponsor requirements, and liaise with clinical trial monitors to ensure the data sent is valid and their requirements are met at site monitoring visits.
• Cross check, confirm data and complete query resolution with sponsors and third parties in a timely manner.
• Completion of clinical trial specific databases with data from various sources such as questionnaires, hospital records and other electronic and paper sources.
• Liaise with internal and external NHS staff regarding case notes, data collection, archival tumour blocks, mortality data, and other general trial activities, which may be confidential and sensitive in nature.
• Ensure that data is available and up to date for any meetings related to a clinical trial.
• If required attend project related meetings, investigator meetings (abroad or teleconferences, as necessary) to convey the relevant information to the study team.
• Undertake general administrative tasks related to clinical trials as delegated by your line manager.
• Assist with preparation for audit and inspections within assigned teams.

WORKING PRACTICE

• Work closely with the Research Division’s management team to ensure adherence to new SOPs and working procedures rolled out divisionally.
• Be pro-active in providing feedback on working practices within the research team and suggest new ways of working.
• The post holder is expected to use initiative and be able to work independently without close supervision. They are also expected to plan and organise their own time and workload activity with prioritisation, referring to the Senior Clinical Trials Coordinators/ Research Nurses as necessary.

Personal Education, Training and Development

• Undertake continuous professional development, seeking opportunities to enhance skills via a personal development plan.
• Participation in trust-wide education programmes and study days.
• To keep up to date with departmental, Trust, UK and EU developments for the management of clinical research ensuring timely, effective implementation of changes.

Applicant requirements

This post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service.