The successful applicant will join the existing research team at Marine Lake Medical Practice with a specific focus on supporting research across Cheshire and Merseyside. Their main place of work will be Marine Lake Medical Practice, but they will also support practices in the Wirral, Cheshire West and Warrington region, forming part of the C&M PC CRDC team. We would like an adaptable individual who is happy with this flexible arrangement. They will:
- Contribute to the planning, conduct and reporting of commercially sponsored clinical trials within a primary care setting
- Be responsible for the management of patient recruitment and retention to research studies across multiple sites
- Work with minimal supervision as part of a team and in collaboration with the Cheshire & Merseyside PC CRDC team
- Ensure all research activity is ICH GCP compliant and conducted in accordance with protocols, sponsor requirements and the Research Governance Framework
- Maintain a high standard of patient care in line with practice policies
- Ensure all data is collected and managed accurately and within agreed timelines
- Provide flexible, mobile and remote research support across participating sites, including virtual consultations, data entry, and remote monitoring activities where appropriate
- Liaise with study sponsors, Contract Research Organisations (CROs), Clinical Research Networks and multi-disciplinary research teams
- Support and promote Patient and Public Involvement and Engagement in research
Main duties of the job
- Assist in assessment and screening of patients for eligibility for research and monitor their condition throughout their participation
- Provide ongoing advice and information to patients regarding their participation in clinical research, ensuring effective informed consent
- Documentation of, reporting and management of adverse events as dictated by study protocols and GCP
- Co-ordinate and conduct patient visits (site-based and remote), specialist tests, data collection, coding, data entry and patient support
- Venepuncture, venous cannulation, administration of IV drugs, vital sign recording
- Collection, processing and shipping biological samples
- Support commercially sponsored studies, ensuring compliance with contractual obligations and timelines
- Assist with data analysis and preparation of reports, presentations, and publications
- Ensure patient safety is paramount in all research procedures
- Ensure record keeping across multiple sites is completed in accordance with ICH GCP and sponsor expectations
- Travel as required between participating practices or partner sites to support recruitment, study delivery, monitoring, and staff training
- Mentorship and training to staff and students involved in research
- Work flexibly, including outside of standard working hours, to support multi-site research activity where required
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.
Job responsibilities
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
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
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 Job Description
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.
Person Specification
Experience
- Experience of working with patients and liaising with staff at all levels in healthcare.
- Experience of supervising nursing or healthcare students.
- History of working within primary care, particularly primary care research
- Experience of working on commercially sponsored research studies.
- Previous experience of coordinating research studies.
- Experience of remote working across multiple sites.
- experience of working collaboratively across different organisations and stakeholders.
Qualifications
- Degree in Nursing,
- NMC PIN holder,
- Current UK driving license holder
Knowledge and Skills
- 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
- Able to use a personal computer, (computer literacy and proficiency in MS Office / EDCL)
- Skills in administration and project management
- Good communication, presentation, 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
- 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
- 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
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.
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