clinical research associate Norwich, England
Job description
The post involves identifying, recruiting, educating and monitoring patients and participants in clinical research studies and to collect and document accurate data in Primary Care settings. This includes the provision of education and support to practice teams in relation to clinical research studies.
This post is subject to Criminal Records Bureau clearance (enhanced).
The Research Nurse will be a member of the CRN Eastern Primary Care Norfolk and Waveney based at Norfolk Community Health and Care NHS Trust.
Responsibilities involves identifying, recruiting, educating and monitor patients and participants in clinical research studies and to collect and document accurate data. This includes the provision of education and support to practice teams in relation to clinical research studies.
The post holder may be required to take responsibility for the safe administration of experimental drugs in accordance with current competencies and for monitoring the expected and unexpected side effects of drugs and other treatment modalities.
The post holder will work collaboratively with members of general practices and primary care teams across a range of sites and with key individuals in the host organisation.
Collaboration with researchers and other network staff in the secondary care setting will be required. From time to time the post holder may be required to work across other locality areas.
The role involves using an in depth knowledge of study protocols and their application in practice alongside a working knowledge and compliance with local and national research regulations.
The post will require some flexible working in order to meet the requirements of recruitment and the research protocol and possibly some unsocial hours. The post holder may be required to visit research participants in their own homes. This post requires the ability to travel routinely within the East of England and to travel outside the region, as required, for the role.
CRN Eastern is a part of the NIHR clinical research network (the research arm of the NHS) and aims to improve the speed, quality and integration of research, ultimately resulting in improved patient care.
This post supports the Clinical Research Network in the Eastern Region as part of the Primary Care Norfolk and Waveney Delivery Team.
This post is based at Norfolk Community Health and Care:
West Pottergate Health Centre, 137 West Pottergate, Norwich NR2 4BX and covers the Norfolk and Waveney Area.
Apply now to join an organisation that has been awarded an Outstanding rating by the Care
Quality Commission (CQC), the highest possible rating and the first stand-alone NHS
community trust in the country to be awarded the title
Professional Responsibilities
- To work with the NMC Code of Conduct and scope of professional conduct
- To be responsible for developing and sustaining own knowledge, clinical skills and professional awareness including clinical supervision.
- To conduct research in accordance with relevant guidelines such as ICH GCP Guidelines, EU Clinical Trials Directive and Research Governance Framework in order to protect the research participants and quality of each study.
- To attend courses, meetings and conferences as deemed relevant
- To ensure that the CRN wide standards are maintained and monitored to improve the quality of care of care to all those who come in contact with the service.
- To organise workload to ensure that the interest of the research participants are met.
- To prioritise patient safety and accurate data collection in line with GCP principles
- To work within and monitor the standards of care as defined in the research protocols, policies and procedures of the CRN Eastern to ensure adherence to and delivery of high quality service.
- To contribute to the development of policies and procedures of the CRN Eastern Primary Care and within the workplace to ensure that clinical practice is underpinned by current best practice.
- To support the safe administration of treatments and drugs given within the context of a clinical trial.
- To ensure that trial specific investigations are undertaken as required by the trial protocol including to undertake clinical procedures and clinical sampling and processing and shipping of samples as required
- With appropriate training, to take clinical samples for studies, and ensure the processing and storage and dispatch of biological samples meets the requirements of the research protocol in order to make certain that safe handling and quality is assured.
- To maintain effective communication with research participants their relatives/carers and members of the multi-disciplinary teams
- To ensure data is recorded accurately and in accordance with regulatory requirements in appropriate study documentation.
- To ensure all projects are assured by the Norfolk and Suffolk Primary and Community Care Research Office and are in receipt of Research Ethical favourable opinion before patients are approached with research projects.
- To provide support to clinical investigators in obtaining approval and assurances.
- To become familiar with each research protocol and it’s application in practice including procedures and documentation to ensure safe and accurate conduct and recording within the study.
- To identify, screen and recruit eligible participants into research studies according to specific protocols and guidelines.
- To co-ordinate recruitment for a local portfolio of clinical studies across participating sites/practices.
- To provide information, education and support to clinical team members, regarding clinical studies.
- To facilitate the informed consent process ensuring the following is accounted for: • The patient (and significant others) fully understands the nature of the clinical trial.
- The patient is aware that entry into the trial is voluntary and they can withdraw at any point without prejudice.
- The patient is aware of any extra procedures required by the trial.
- The consent form is completed accurately and filed as required.
- To disseminate up to date information, protocol amendments etc to personnel working on research projects.
- To be responsible for monitoring trial data/accrual in clinical studies and forwarding it in a timely manner to the locality CRN Eastern Primary Care Locality Manager. Liaise with clinical trial personnel, as necessary.
- To identify barriers to recruitment to studies and ensure that the CRN Eastern Primary care Locality Manager is aware of them. Identify and implement action/plans as required.
- Report all serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs) immediately following appropriate procedures.
- Co-coordinate/assist in the dissemination of research findings internally and externally
- To make clinical and professional autonomous decisions on a daily basis
- To provide clinical and professional advice to the multi-disciplinary team.
- To make an assessment of the subject’s condition to establish if necessary the appropriate action and future participation in the study.
- To act in the best interest of the research participants to ensure their rights are upheld when identifying screening and recruiting participants into trials/research studies.
- To recognise that freedom to act is guided by precedent and clearly defined protocols and procedures and codes of conduct in accordance with CCG and CRN-EoE policies, NMC Code of Conduct, ICH GCP, Research Governance, EU Clinical Trials Directive, Mental Capacity Act, and Data Protection Act.
- To liaise closely with other CRN Eastern Research Nurses and Network Facilitators within and across the localities
- To liaise with key identified personnel in the host Norfolk Community Health and Care NHS Trust
- To provide information and education about the CRN-EoE and its research projects to interested parties.
- To communicate with research participants, their relatives/carers and with the multi-disciplinary team involved in the provision of care associated with the research study.
- Ensure the provision of appropriate verbal and written information, to potential research participants thus empowering the patient to make informed decisions
- To communicate effectively with all stakeholders. Liaise with other departments as needed to ensure study interventions are conducted in a timely manner
- To work as an effective team members with the aim of maximising patient recruitment to NIHR adopted studies within time and target.
- To attend CRN Eastern Primary Care team meetings
- To attend meetings relating to specific research projects as necessary.
- To assist with the creation of relevant CRN Eastern Primary Care training packages.
- To cover duties of other Research Nurses when required.
- To undertake any other duties, which may be required from time to time, as are consistent with the responsibilities of the grade and needs of the service.
