Clinical Research Practitioner

Job overview

Please note that these posts are permanent contracts at 37.5 hours per week.

We are looking to appoint a Research Practitioner (Band 4) in the Melanoma 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 both the clinical and administrative functions of the Melanoma Research Team, supporting the delivery of a diverse portfolio of research studies. Clinical duties, undertaken under the supervision of clinical research nurses, will include providing patient support within agreed competencies, collecting biological samples, recording observations, gathering study data, and administering quality of life questionnaires. Administrative responsibilities, supported by the Research Manager, will include managing aspects of clinical research projects, entering patient visit data, responding to study queries, maintaining trial records, filing essential documents, supporting invoicing processes, liaising with pharmaceutical companies, collaborating with the wider R&I team, and assisting with general administrative activities.

Post holders will actively participate in their personal development and appraisal process to achieve role objectives and should hold, or be working towards, the National Care Certificate.

The Melanoma Research Team has a strong collaborative ethos, requiring close working relationships with a wide range of staff. Full training and ongoing development opportunities are provided to support career progression within the Trust. This is a challenging but rewarding role within a supportive, dedicated team committed to excellence in research and patient care.

Detailed job description and main responsibilities

RESEARCH

KEY VALUES

• 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.
• 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.
• Demonstrates the agreed set of values and accountable for own attitude and behaviour.

Applicant requirements

The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.