Clinical Research Assistant

Job overview

We are seeking a motivated and organised Clinical Research Associate to join our dynamic Integrative Therapy, Health and Wellbeing Service at The Christie. This is a permanent position, working full time Monday to Friday, offering an excellent opportunity to contribute to high-quality clinical research within a supportive oncology setting. The post holder will lead on all aspects of clinical study administration, ensuring research is delivered in line with Good Clinical Practice (GCP), Trust policies, standard operating procedures and regulatory requirements. Working under the supervision of the Nurse Consultant, you will support research delivery and quality assurance projects that enhance patient care and experience. You will work closely with multidisciplinary teams, including clinical staff, research nurses, principal investigators and external partners, supporting study set-up, patient recruitment, data management and reporting. This role requires strong organisational skills, attention to detail and the ability to manage competing priorities. When applying for this position, please refer to the person specification and demonstrate within your application how you meet the criteria, providing examples where possible.

Main duties of the job

The Clinical Research Associate will coordinate and deliver research activity within the Integrative Therapy, Health and Wellbeing Service, ensuring compliance with GCP, Trust SOPs and regulatory standards. You will support study set-up, manage research documentation, and act as a key point of contact between the clinical team, R&D, study sponsors and external partners. Responsibilities include maintaining investigator site files, processing study amendments, supporting safety reporting, and preparing for audits and inspections. The role involves supporting patient recruitment, obtaining informed consent where appropriate, and providing information and support to research participants. You will contribute to data collection, including qualitative interviews and clinical data extraction, and support analysis, reporting, publications and service evaluations. You will also support audit processes and quality assurance activities, working closely with the Quality Manager and wider team to drive continuous improvement. You will be confident in your skills, committed to delivering excellent patient-centred care, and able to work independently while contributing effectively within a multidisciplinary team.

Detailed job description and main responsibilities

DUTIES AND RESPONSIBILITIES:

• Day to day responsibility for the efficient and timely set up of clinical research.
• Liaise with the wider clinical team to identify possible sources of patient recruitment.
• Manage own workload for daily research activity including case report form completion and amendment processing to meet internal and external deadlines.
• Day to day responsibility for quality assurance of all research related documentation in accordance with relevant legislation and guidelines.
• Lead on preparation for audit and inspections of research documentation as required.
• Advise and support CH&W Quality Manager on audit process/documentation.
• General trial-related communication in accordance with the Data Protection Act.

CLINICAL RESEARCH ADMINSTRATION AND DATA MANAGEMENT

• Act as a point of contact between the R&D core team, study sponsors, clinical research organisations and specific research and clinical team, communicating directly with them regarding data queries, monitoring visits and other enquiries relevant to trial/project set up and general trial/project conduct.
• Set-up and initiation of research within the team.
• Maintain investigator site files in accordance with ICH-GCP and Trust SOPs.
• Process study amendment submissions in accordance with ICH-GCP and Trust SOPs and timelines.
• Have administrative responsibility in liaison with the Clinical Research Nurse and Principal Investigators for safety reporting in accordance with protocol requirements.
• Complete team reporting mechanisms (i.e. recruitment activity logs, patient visit logs, costing spreadsheets, case report form trackers and electronic proformas).
• Produce study workbooks in collaboration with the Nurse Consultant and Principal Investigators.
• Ensure collection of clinical case notes for all patients, so that these are available as needed, for monitoring and audit purposes.
• Complete case report forms in collaboration with Research Nurses 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.
• Liaise with internal and external NHS staff regarding case notes, data collection and other general trial activities, which may be confidential and sensitive in nature.
• Ensure that any additional source data is reproduced in a timely manner for the purposes of the clinical trial and dispatched according to study protocol.
• Arrange team and trial/project related meetings as required, producing minutes in a timely manner.
• Ensure that data is available and up to date for any meetings related to a clinical trial/project.
• Attend project related meetings, investigator meetings (or teleconferences, as necessary) to convey the relevant information to the study team.
• Facilitate preparation for audit and inspections as appropriate.
• Overseeing trial/project document archiving by following the Trust’s archiving guidelines.

ADDITIONAL DUTIES

• Undertake qualitative research data collection / interviews, including awareness of when to pause interviews due to signs of participant distress. Debrief participants according to appropriate guidance and signpost them to relevant support if required.
• Collect data as required as part of a study including self-report measures and rating scales.
• Extract and code data from clinical notes.
• Analysis of qualitative data as appropriate in collaboration with relevant members of the research team.
• Facilitate recruitment, data monitoring, data collection, data entry and data analysis.
• Co-lead on reports, publications, and abstracts as appropriate.
• Ensure the security and confidentiality of data.
• Undertake relevant literature searches, summarising research, and drafting papers for publication.
• Prepare progress reports as necessary and undertake administrative tasks as needed.
• Ability to take informed consent from patient (parent/guardian, next of kin, as appropriate) ensuring full understanding of the nature of the research, voluntary participation, and freedom to withdraw at any time without prejudice to treatment and care.
• Provide verbal and written information and support to research participants for the duration of their involvement in the research project as appropriate.
• Support with completion of the study project plan/Gantt chart.
• Organise, attend, and write minutes for steering group and research team meetings as appropriate to individual studies.
• Share knowledge and information with colleagues regarding research studies in progress.
• Support/contribute to writing research grant applications.
• Support management in writing and updating relevant documents within the department.

WORKING PRACTICE

• Work closely with senior trial management / PI / Nurse Consultant as relevant to individual studies, to ensure adherence to SOPs and working procedures.
• Be pro-active in providing feedback on working practices within the research/clinical team and suggest new ways of working as appropriate.
• Use initiative and be able to work independently without close supervision, plan and organise activity with prioritisation, referring to the Nurse Consultant as necessary.

PERSONAL AND PEOPLE DEVELOPMENT

• Maintain professional development (including GCP) whilst evaluating own specialist knowledge with assistance from the assigned line manager, to satisfy the NHS Knowledge and Skills Framework.
• Participate in Trust-wide education programmes and study days, regional and national meetings, and research seminars as appropriate.
• Assist with induction training and support for new post holders under the direction of the senior management team.
• Ensure all mandatory training is up to date and further relevant training for the role is completed.

AD HOC DUTIES

• Ensure that office supplies are adequate, ordered and obtained for the smooth running of the assigned research team.
• Re-order trial related supplies as required.
• Assist in all areas of R&D administration as required.
• Propose, conduct, and write up audit reports and service evaluations in collaboration with clinical team as appropriate.

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.