Job Description

The successful applicant will join the existing research at Marine Lake Medical Practice but have a specific focus on supporting research across the Cheshire and Merseyside footprint. Their day-to-day place of work will be Marine Lake Medical Practice, but there will be an expectation that this individual will support practices in the Wirral, Cheshire West and Warrington region as needed (study set up and delivery). They will also form part of the new C&M PC CRDC team which include Clinical Directors, Clinical Leads, PC CRDC Manager, 2 Research Nurses covering the Liverpool, Sefton, St Helens, and Cheshire East Geography, and a PPIE Lead. This is a novel role for a novel organization, we would like an adaptable individual who is happy with the flexible arrangement described above.

To contribute to all aspects of the planning, conduct and reporting of commercially sponsored clinical trials and research studies within a primary care setting. To be responsible for the management of patient recruitment and retention to research studies across multiple sites. To work with minimal supervision as part of a research team and in collaboration with the Cheshire & Merseyside PC-CRDC Team. To ensure that all clinical research activity is ICH GCP compliant and conducted in accordance with agreed protocols, sponsor requirements and the Research Governance Framework. To maintain a high standard of patient care in line with practice policies and protocols. To ensure that all data is collected and managed accurately and within agreed timelines. To provide flexible, mobile and remote research support across participating sites, including virtual consultations, data entry, and remote monitoring activities where appropriate. To liaise effectively with study sponsors, Contract Research Organisations (CROs), Clinical Research Networks and multi-disciplinary research teams. To support and promote Patient and Public Involvement and Engagement (PPIE) in research.

Key Responsibilities

To assist in the assessment and screening of patients/volunteers for eligibility for research and to monitor their condition throughout their participation. To provide ongoing advice and information to patients/volunteers regarding their participation in clinical research, ensuring effective informed consent. To assist in the documentation, reporting and management of adverse events as dictated by study protocols, sponsor requirements and local policies. To co-ordinate and conduct patient visits in accordance with study protocols, including site-based and remote visits, specialist tests, data collection, coding, data entry and patient support. To conduct/ support with consent, treatment procedures and treatment interventions according to pre-determined protocols, including venepuncture, venous cannulation, administration of intravenous drugs, and vital sign recording. To carry out the collection, processing and shipment of biological samples according to protocol requirements, and to follow up appropriately on alert values. To support commercially sponsored studies, ensuring compliance with contractual obligations, timelines, and documentation requirements, and liaising with sponsors and monitors as required. To contribute to the analysis of data and preparation of reports, presentations, and publications. To ensure patient safety is paramount in all procedures undertaken for research purposes. To ensure all clinical and research documentation and record keeping is completed accurately and efficiently in accordance with ICH GCP and sponsor expectations. To maintain accurate and secure records both manually and electronically across multiple practice sites, ensuring data integrity. To travel as required between participating practices or partner sites to support recruitment, study delivery, monitoring, and staff training. To provide mentorship and training to staff and students involved in research. To work flexibly, including outside of standard working hours, to support multi-site and commercial research activity where required. To follow the policies and procedures of Marine Lake Medical Practice, whilst respecting the applicable processes and procedures when working at other primary care sites.

Remote and Mobile Working

To utilise secure digital systems for remote patient follow-up, data entry, and electronic data capture in accordance with information governance policies. To conduct remote consultations and follow-up assessments where approved within study protocols. To maintain effective communication with team members and investigators across multiple locations through virtual platforms and regular team meetings. To ensure that research-related equipment and materials are safely transported and maintained when working across different sites.

Confidentiality

As per existing policies and procedures, ensuring the protection of patient, staff and organisational information.

Clinical Governance / Quality

To maintain a high standard of patient care in line with practice, sponsor, and R&D policies and protocols, in accordance with the Research Governance Framework.

Equality and Diversity

To support equality, diversity and the rights of patients, carers and colleagues, acting in a way that respects privacy, dignity and individual beliefs.

Health & Safety

The post-holder will assist in promoting and maintaining their own and others' health, safety and security as defined in the practice Health & Safety Policy, to include:

Using personal security systems within the workplace according to practice guidelines

Identifying the risks involved in work activities and undertaking such activities in a way that manages those risks

Making effective use of training to update knowledge and skills

Using appropriate infection control procedures, maintaining work areas in a tidy and safe way and free from hazards

Reporting potential risks identified.

Infection Prevention & Control

All staff will always adhere to infection control policies and procedures and carry out role specific duties as per roles and responsibilities. Safeguarding Children and Vulnerable Adults

All employees are required to act in such a way that always safeguards the health and well-being of children and vulnerable adults. Familiarisation with and adherence to practice safeguarding policies is an essential requirement of all employees, as is participation in related mandatory/statutory training.

IT Skills

All staff are expected to have a minimum of basic level IT skills to enable them to use the practice IT systems to support practice services and needs. All staff should be familiar with relevant IT systems and security policies and procedures. Staff should be proficient in the use of research specific software and IT systems which aide in the remote delivery of research activities, including but not limited to electronic site files, electronic data capture records, electronic participant diaries, electronic case report forms.

Records Management

All staff are personally responsible for record keeping. A record is anything that contains information in any medium e.g. paper, tapes, computer information, etc. which have been created or gathered as a result of any NHS activity. All individuals within the practice are responsible for any records they create or use. Please ensure that records are retained in accordance with the Records Management Policy and are stored in a manner that allows them to be easily located in the event of a Freedom of Information (FOI) request.

Information Quality

All staff must ensure complete and accurate data is always collected to the highest standard. Data collection should be supported by adequate documentation and processes should be regularly reviewed. Staff should ensure that processes conform to national standards and are fit for purpose. All staff should comply with the Information Quality Policy.

Professional Responsibility

To ensure that all clinical research activity is ICH GCP compliant and conducted in accordance with the agreed protocols

Compliance with relevant professional governing bodies & guidance (e.g. NMC Code of Conduct)

Compliance with the Data Protection Act and the Computer Misuse Act

Compliance with practice, Directorate and R&D SOPs, policies and protocols

Maintenance of personal and professional development Clinical Responsibility

To maintain a high standard of patient care in line with and R&D policies and protocols and in accordance with the Research Governance Framework

The post-holder will assist in promoting and maintaining their own and others' health, safety and security as defined in the practice Health & Safety Policy, to include:

Using personal security systems within the workplace according to practice guidelines

Identifying the risks involved in work activities and undertaking such activities in a way that manages those risks

Making effective use of training to update knowledge and skills.

Using appropriate infection control procedures, maintaining work areas in a tidy and safe way and free from hazards

Reporting potential risks identified.

Financial Responsibility

To authorise participant expense payments, manage study resources and equipment as per protocols, and maintain accurate study visit records to facilitate prompt payments, including those from commercial sponsors.

Change of

The duties outlined above are not intended to be exhaustive and may change as the needs of the department and research portfolio evolve, including development of new commercial partnerships and expansion across multiple sites.

Personal Specification

Essential

Qualifications

Up to date training in ICH GCP/research governance

Experience

Primary Care Research Experience

Previous experience of co-ordinating clinical research studies

Experience of liaison with staff at all levels in healthcare

Knowledge

Knowledge of the principles and practice of clinical research and/or clinical trials

Understanding of the role & responsibilities of a clinical research practitioner/ nurse

Knowledge of ethical and quality standards applicable to clinical trials, including EU Directive on ICH GCP requirements

Skills

Ability to use a personal computer, (computer literacy and proficiency in MS Office / EDCL)

Skills in administration and project management

Good communication, presentational, training and interpersonal skills

Ability to meet tight deadlines and cope in a highly demanding environment

Ability to work independently and prioritise / own workload and to communicate effectively with all members of the multi-disciplinary team

Excellent and effective verbal and written communication skills

Skills in handling and management of computerised data

Other

Possession of tact and sensitivity to the needs of both patients and colleagues, including a commitment to confidentiality

Meticulous attention to detail and a high standard of accuracy

Flexible approach to working hours and location

Desirable

Qualifications

1st level degree or studying towards

Experience

Commercial Research Delivery Experience

Clinical experience/qualification in venepuncture, IV cannulation

Supervision of nursing/ medical students

Experience of working collaboratively across different organisations and research stakeholders

Experience of remote/ mobile working across multiple sites

Knowledge

Knowledge of the Health Service, R&D, the pharmaceutical industry partnership and relevant information sciences

Job Types: Full-time, Fixed term contract
Contract length: 36 months

Pay: 19.00 per hour

Expected hours: 35 per week

Work Location: In person