Agile Research Team Support Officer (XN04)

Job description

Job responsibilities

The post holder will play a key role as a member of the Agile Research Team to ensure the NIHR CRN: Yorkshire & Humber provides clinical study support to various clinical specialities conducting research in NHS and other public health and social care environments.

The ART Support Officer will be responsible for the collection, recording and maintaining data of patients on NIHR portfolio studies.

The post holder will support current portfolio research staff in ensuring the completeness, accuracy and consistency of the data in order to meet standards expected for reporting to regulatory bodies.

This role will involve the recruitment and monitoring of patients undergoing clinical research and the collection and documentation of accurate clinical research data.

The post holder will work closely with, and support research nurses/practitioners in providing the highest standards of patient care in line with research protocols and will ensure that such research safeguards the well-being of the patients and is conducted within ICH Good Clinical Practice guidelines for research.

PRINCIPAL DUTIES & AREAS OF RESPONSIBILITY

Research Trial Set Up and Initiation:

Assist with the acquisition and distribution of relevant trial documentation / equipment.

To establish trial site files for each trial in accordance with ICH-GCP and research governance.

Organise and attend site initiation training.

On-going Studies:

Collection of patient data from medical notes, completion of case record forms and to liaise with clinical trial co-ordinators, research nurses and investigators to ensure accurate data collection.

To transcribe/export data from medical records (paper or electronic) to CRFs (paper or electronic) as required by the study protocol.

Facilitate the secure filing and storage of study documentation in accordance with ICH-GCP and Research Governance and conduct quality assurance of documentation.

Organise and prepare for visits by trial monitors as required by the study protocol.

Take responsibility for liaising with clinical trials units regarding data queries and for checking and resolving data queries.

To evaluate patient eligibility, in liaison with other appropriate health care professionals for clinical trial entry, involving coordination of pre study tests, obtaining results and arranging appropriate appointments as per clinical trial protocols.

Clinical Practice:

Have a solid understanding of the application of ICH-GCP Guidelines, the EU Directive on Clinical Research and Research Governance.

To ensure patients / carers are provided with written information relevant to the research study and are given the opportunity to discuss the research study or clinical trial adequately at the outset and during the course of the research or clinical trial in which they are being asked to participate (i.e. informed consent).

Attend and support patients in the clinical environment for monitoring, assessment and follow up as part of research projects.

Where appropriate, to take consent from patients/participants to enter research studies.

To take relevant patient samples for clinical trials; such as blood samples to centrifuge and separate serum, package and dispatch as per defined protocols, where appropriate.

Observe patients and monitor treatment toxicity/side effects, escalating findings accordingly.

Maintain accurate patient trial documentation, complete Case Record Forms, including the use of electronic data capture systems and ensure relevant information is recorded in patients medical notes.

Ensure safety data is reported in line with SOPs and study protocols, and reports are sent in a timely manner.

To ensure safe and appropriate storage of specimens in accordance with the trial protocol and in conjunction with specialist teams.

To record and report any adverse and serious adverse events according to trial protocol and local procedure.

Communication and Relationship Skills:

Establish and maintain effective working relationships with all relevant organisations and individuals, including member NHS Trusts, other NIHR Clinical research networks and other providers of NHS services within the CRN, Clinical Trials Units, Industry, and NHS commissioners.

Other:

To undertake mandatory training as required by the individual Trusts and additional clinical, research and IT training as required by the research studies.

Work to Standard Operating Procedures (SOPs), applicable regulatory requirements and laws as per required and applicable to each research study, department and Trust.

As the post will cover a number of NHS Trusts and Community partner organisations, there will be a need to travel around the geographical area covered by the CRN: Y&H as required.

Person Specification

Qualifications

Essential

• Minimum of five Grade C (four new grading system) or above GCSE/Equivalent.
• Diploma level qualification i.e. NVQ3 plus ECDL etc. or equivalent demonstrable experience.
• Awareness of the importance of data confidentiality.

Desirable

• Evidence of appropriate further education/ development.
• Research qualification.
• Knowledge of ICH-GCP
• Is aware of current legislation regarding research governance issues.
• ICT Qualification.

Experience

Essential

• Significant administrative/ data management experience preferably in an NHS setting.
• Demonstrable relevant CPD.
• Good IT Skills, particularly in the use of Web applications and MS Office applications.
• Computer literate with Microsoft software (including Word, Excel & PowerPoint.
• Access database handling.
• Ability to work on own with minimal supervision.
• Excellent communication and interpersonal skills both written and verbal.

Desirable

• Experience of working within a clinical trial setting.
• Knowledge of research methodologies.
• Experience in developing, implementing and following standard procedures.
• Experience of the clinical care of patients enrolled in research studies.
• Evidence of accuracy in data collection.
• Willing to undertake personal development training as required
• Current clinical skills including phlebotomy, ECG recording, vital signs recording etc. Sample preparation and handling.

Skills & Behaviours

Essential

• Be enthusiastic for the field of clinical research and a strong desire to improve patient outcomes and wellbeing through the conduct of high-quality research.
• Confident approach with the ability to instil confidence in others.
• Motivated and able to motivate and develop others.
• Logical approach to problem solving and ability to be objective.
• Highly responsive to requests for help.
• Invest time to understand the needs, priorities and goals of others they are working with.
• Mature, flexible and co-operative approach. Friendly, professional and outgoing manner.
• Respects confidentiality and confidences.
• Considerate of other peoples views.
• Honest, respectful and professional in all interactions. Listens to concerns or complaints.
• Understands how their work is contributing to the wider Network strategy.
• Helps others to resolve problems and address issues. Ensures decisions are communicated to others who need to know.
• Conveys confidence in others capabilities and promotes their success.
• Delivers on commitments and promises.
• Contributes to decisions about the future direction of the Network.

Practical Skills or Additional Requirements

Essential

• Ability to work independently and as part of a small specialist team.
• Ability to communicate difficult and sometimes challenging information both orally and in writing both internally to colleagues and externally to a range of audiences.
• Ability to prepare and deliver presentations and reports to a high standard.
• Strong problem solving and negotiation skills. Willingness to undergo personal development and learn new skills.
• Ability to manage time effectively, prioritise work and to deliver results consistently to tight deadlines.
• Ability to deliver complex projects, involving multiple agencies and individuals and a range of tasks.
• Desk based, some light lifting (e.g. research equipment and stationery) and travelling across Trusts within the CRN: Y&H region. Able to fulfil Occupational Health requirements for the post (with reas
• Frequent requirement for concentration, work pattern is unpredictable, and work is likely to be frequently interrupted to deal with queries.
• The post holder may have to deal with complex research issues involving difficult conversations with researchers, other RM&G and R&D staff and will need to do this tactfully and tenaciously. Office co
• Travelling by car or public transport required. Car driver and/or another suitable means of transport for business use in order to fulfil the needs of the role.

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

Leeds Teaching Hospitals

Address

St. James's University Hospital

Beckett Street

Leeds

LS9 7TF

Employer's website

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