Job summary
We have an exciting opportunity
to join our award winning research team at Oak Tree Surgery and Pensilva
Health Centre . The position is for a Clinical Research Nurse/Co-Ordinator to assist with
the running of a number of new and on-going clinical
trials. Working as part of small,
friendly research team the successful candidate would gain valuable experience
in all aspects of a trial management from feasibility to study close down of both commercial and
non-commercial trials.
A dynamic and enthusiastic individual is
required as we seek to increase our portfolio of studies and to develop
research partnerships with other organisations.
Advert may close early subject to sufficient suitable applications. Job share/flexible hours considered.
- Stable and long established large practice operating from two modern purpose built buildings (both dispensing sites)
- 17,000 patient list size
- Clinical team consists of 13 GPs and trainees, Large ANP team, Mental Health Practitioner, Physicians Associate, First Contact Physiotherapists, and Clinical Pharmacist.
- Large Nursing and Admin Teams who absorb most of the chronic disease, tasks, non-complex clinical care and admin work, all geared towards reducing GP/Clinical workload
- Excellent IT support systems
- In house pharmacy staffed by a Pharmacist led medicines management team
- Teaching and GP Training Practice
- Remote triage practice using the latest technology to deliver virtual consultations
- In house clinical research unit
- EMIS Web clinical system
Main duties of the job
The post holder will be
involved in the coordination and delivery of research at Oak Tree Surgery and
Pensilva Health Centre, assisting with and planning the care pathways for
patients participating in clinical trials and academic research. This will
involve the recruitment, screening, education and monitoring of trial patients
and the collection and documentation of accurate data.
The post holder will be able to
work both as a member of the team and independently as required and have
excellent communication skills. They will provide relevant clinical
skills/competencies including phlebotomy, ECG and medicines administration. The
post holder will be responsible for the nursing care of study patients
including the monitoring and reporting of adverse events. The role involves
using an in depth knowledge of the trial protocol and its application in practice,
alongside a working knowledge and compliance with the local, national and
international guidelines and laws.
About us
Our aim is to provide high quality healthcare for all. We are a large innovative practice operating from two sites situated in South East Cornwall with a great mix of rural and market town patients. We are within easy distance of the picturesque south coast and the stunning north coast with rugged moorland in between, fantastic for an outdoor lifestyle whilst still within a reasonable visiting distance of cities like Truro and Plymouth.
Some of the benefits of working in our clinical team include:
- 5 weeks annual leave per year plus bank holidays
- 1 week CPD leave
- Regular half day practice closures for staff training, team building and wellbeing activities
- Electric vehicle salary sacrifice scheme
- Free on-site parking
- Company sick pay
- Regular social events including annual company funded Christmas party
- Numerous charity fundraising events throughout the year
- Lunch break staff walking group
- Monthly team meetings for shared learning
Fun, friendly, and highly motivated team of individuals who all work together in a welcoming and supportive environment.We strive to be leaders in the health and wellbeing of our staff and patients.
Job description
Job responsibilities
Overview of Essential Responsibilities
Clinical Research
- To work according to ICH GCP guidelines and research governance standards for clinical trials and current Standard Operating Procedures.
- To support the implementation, coordination and management of a limited range of clinical trial protocols.
- To assist in the identification, screening and recruitment of patients/volunteers into research studies according to the inclusion and exclusion criteria to ensure the effective achievement of study aims and monitoring of their condition throughout participation.
- To register/randomise patients into trials.
- Working with senior colleagues in obtaining informed consent as delegated by the Principal Investigator.
- To provide ongoing advice and information to patients/volunteers with regard to their participation in clinical research in order to facilitate effective informed consent.
- To act in the best interest of the research subjects and to ensure that their rights are upheld. Treat all persons encountered within course of his/her duties with respect and courtesy.
- To facilitate the informed consent process ensuring the following is accounted for:-
- The patient (and significant others) fully understand the nature of the clinical trial.
- The patient is aware that entry onto the trial is voluntary and they can withdraw at any time 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 co-ordinate visit schedules of research participants liaising with team members as necessary.
- To provide on-going follow-up care whilst the patient is in the clinical trial.
- To acquire and maintain a range of clinical skills necessary to facilitate research as determined by the research protocol i.e.: phlebotomy, vital sign assessment, clinical assessments and ECG recording as appropriate.
- To carry out associated laboratory work safely and in line with national requirements including:
- Centrifugation of blood samples and slide preparation
- Aliquoting and storage of samples at appropriate temperatures
- Order dry ice in advance of patient visit
- Pack samples ready for shipment
- Coordinate courier collection
- To process and store biological samples to the requirements of the research protocol, ensuring that safe handling and quality is assured
- To ensure the safe ordering and storage of study medication prior to dispensing to clients
- To ensure the safe administration of treatments and drugs given within the context of a clinical trials adhering to local and national guidelines
- To perform other clinical procedures as specified by the protocol
- To be competent in managing emergency situations such as cardiac arrest, major incident and fire procedures as they relate to the departments
- To participate in clinical trials monitoring as required to meet the governance requirements of each study
- To monitor treatment toxicity/side effects, report this these to the Principle or Sub-Investigator and initiate changes to treatment as required
- To record and report adverse events/serious adverse events which occur whilst the patient is in the clinical trial to the relevant personnel and act as required. This may include the trial co-coordinator/Principle Investigator and relevant local personnel/regulatory authorities in the event of serious adverse events
- To manage the organisation of own workload on a day to day basis
- To update the Senior Research Nurse/Research Nurse Manager on the progress of clinical trials
Administration
- To ensure that all documentation including paper or electronic clinical research files, letters, and the surgery patient record are completed with a high degree of accuracy.
- Update excel spreadsheets and create Word documents as necessary.
- To liaise as necessary via email, telephone or writing with the project co-ordinator, sponsor, medical staff and other agencies involved to enable efficient running of the trials and maintain patient safety
- To access the computer network as required to retrieve relevant information.
- To assist with the archiving of clinical trials as required.
- Ensure site files are well organised and filing attended to in a timely manner. Ensure site files are maintained according to sponsor and research governance requirements
- Enter clinical data onto electronic data capture systems or study portals as per study requirements
Professional Responsibilities
- To work within professional codes, being aware of own limitations and to seek advice as necessary, referring research patients to other personnel as and when appropriate
- To work as part of the multidisciplinary team and contribute to the ongoing development and smooth running of the surgery
- To contribute to clinical governance at a level appropriate to the post holders knowledge and experience
- To be responsible for maintaining strong relationships and positive communication channels with other key personnel both within and outside the surgery as necessary
- To contribute to the delivery of a high standard of care to all study participants irrespective of sexual orientation, age, and gender
- To adhere to the surgeries general conditions of employment
- To observe the confidentiality of patient information at all times, written, verbal and electronic, in accordance with the Data Protection Act, whilst being aware of the Freedom for Information Act
- To promptly report all incidents or accidents involving patients, visitors or staff and take appropriate action according to surgery policy
Educational Responsibilities
- To ensure own practice is up to date and evidence based and to demonstrate an awareness of current, relevant research
- To maintain Continuous Professional Development in line with NMC guidelines, as necessary to support job role and actively maintain a personal professional portfolio
- To further develop knowledge and skills relevant to the research area by undertaking appropriate training, courses of study and attendance at meetings and conferences as appropriate
- To attend site initiation visits, investigator meetings and Interim study meetings as required
- To attend departmental and other meetings relevant to the post as required and under the direction of the Senior Research Nurse or line manager
- To be willing to undertake further training to meet the needs of research protocols as required
- To assist, as necessary, in the training of new staff commensurate with own knowledge and experience
Specific Additional Responsibilities
- To provide cover for staff during periods of absence as required
- The post holder will be expected to carry out administrative duties to fulfil the roles outlined above and other duties appropriate to the post
- To work either at Pensilva Health Centre or Oak Tree Surgery as per organisational requirements
Job description
Job responsibilities
Overview of Essential Responsibilities
Clinical Research
- To work according to ICH GCP guidelines and research governance standards for clinical trials and current Standard Operating Procedures.
- To support the implementation, coordination and management of a limited range of clinical trial protocols.
- To assist in the identification, screening and recruitment of patients/volunteers into research studies according to the inclusion and exclusion criteria to ensure the effective achievement of study aims and monitoring of their condition throughout participation.
- To register/randomise patients into trials.
- Working with senior colleagues in obtaining informed consent as delegated by the Principal Investigator.
- To provide ongoing advice and information to patients/volunteers with regard to their participation in clinical research in order to facilitate effective informed consent.
- To act in the best interest of the research subjects and to ensure that their rights are upheld. Treat all persons encountered within course of his/her duties with respect and courtesy.
- To facilitate the informed consent process ensuring the following is accounted for:-
- The patient (and significant others) fully understand the nature of the clinical trial.
- The patient is aware that entry onto the trial is voluntary and they can withdraw at any time 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 co-ordinate visit schedules of research participants liaising with team members as necessary.
- To provide on-going follow-up care whilst the patient is in the clinical trial.
- To acquire and maintain a range of clinical skills necessary to facilitate research as determined by the research protocol i.e.: phlebotomy, vital sign assessment, clinical assessments and ECG recording as appropriate.
- To carry out associated laboratory work safely and in line with national requirements including:
- Centrifugation of blood samples and slide preparation
- Aliquoting and storage of samples at appropriate temperatures
- Order dry ice in advance of patient visit
- Pack samples ready for shipment
- Coordinate courier collection
- To process and store biological samples to the requirements of the research protocol, ensuring that safe handling and quality is assured
- To ensure the safe ordering and storage of study medication prior to dispensing to clients
- To ensure the safe administration of treatments and drugs given within the context of a clinical trials adhering to local and national guidelines
- To perform other clinical procedures as specified by the protocol
- To be competent in managing emergency situations such as cardiac arrest, major incident and fire procedures as they relate to the departments
- To participate in clinical trials monitoring as required to meet the governance requirements of each study
- To monitor treatment toxicity/side effects, report this these to the Principle or Sub-Investigator and initiate changes to treatment as required
- To record and report adverse events/serious adverse events which occur whilst the patient is in the clinical trial to the relevant personnel and act as required. This may include the trial co-coordinator/Principle Investigator and relevant local personnel/regulatory authorities in the event of serious adverse events
- To manage the organisation of own workload on a day to day basis
- To update the Senior Research Nurse/Research Nurse Manager on the progress of clinical trials
Administration
- To ensure that all documentation including paper or electronic clinical research files, letters, and the surgery patient record are completed with a high degree of accuracy.
- Update excel spreadsheets and create Word documents as necessary.
- To liaise as necessary via email, telephone or writing with the project co-ordinator, sponsor, medical staff and other agencies involved to enable efficient running of the trials and maintain patient safety
- To access the computer network as required to retrieve relevant information.
- To assist with the archiving of clinical trials as required.
- Ensure site files are well organised and filing attended to in a timely manner. Ensure site files are maintained according to sponsor and research governance requirements
- Enter clinical data onto electronic data capture systems or study portals as per study requirements
Professional Responsibilities
- To work within professional codes, being aware of own limitations and to seek advice as necessary, referring research patients to other personnel as and when appropriate
- To work as part of the multidisciplinary team and contribute to the ongoing development and smooth running of the surgery
- To contribute to clinical governance at a level appropriate to the post holders knowledge and experience
- To be responsible for maintaining strong relationships and positive communication channels with other key personnel both within and outside the surgery as necessary
- To contribute to the delivery of a high standard of care to all study participants irrespective of sexual orientation, age, and gender
- To adhere to the surgeries general conditions of employment
- To observe the confidentiality of patient information at all times, written, verbal and electronic, in accordance with the Data Protection Act, whilst being aware of the Freedom for Information Act
- To promptly report all incidents or accidents involving patients, visitors or staff and take appropriate action according to surgery policy
Educational Responsibilities
- To ensure own practice is up to date and evidence based and to demonstrate an awareness of current, relevant research
- To maintain Continuous Professional Development in line with NMC guidelines, as necessary to support job role and actively maintain a personal professional portfolio
- To further develop knowledge and skills relevant to the research area by undertaking appropriate training, courses of study and attendance at meetings and conferences as appropriate
- To attend site initiation visits, investigator meetings and Interim study meetings as required
- To attend departmental and other meetings relevant to the post as required and under the direction of the Senior Research Nurse or line manager
- To be willing to undertake further training to meet the needs of research protocols as required
- To assist, as necessary, in the training of new staff commensurate with own knowledge and experience
Specific Additional Responsibilities
- To provide cover for staff during periods of absence as required
- The post holder will be expected to carry out administrative duties to fulfil the roles outlined above and other duties appropriate to the post
- To work either at Pensilva Health Centre or Oak Tree Surgery as per organisational requirements
Person Specification
Qualifications
Essential
- Must be a Registered Nurse
Experience
Essential
- Demonstrable research experience
- Excellent communication skills
- Demonstrable experience in Excel /Word
- Demonstrable experience of working under their own initiative
- Excellent organisation skills
- Competent in phlebotomy, administering injections, ECGs and up to date good clinical skills
- A good knowledge of ICH GCP Guidelines
Desirable
- Experience of working in primary care preferred
- Experience of managing own workload as well as working well with others
- Experience of working on EMIS WEB
Person Specification
Qualifications
Essential
- Must be a Registered Nurse
Experience
Essential
- Demonstrable research experience
- Excellent communication skills
- Demonstrable experience in Excel /Word
- Demonstrable experience of working under their own initiative
- Excellent organisation skills
- Competent in phlebotomy, administering injections, ECGs and up to date good clinical skills
- A good knowledge of ICH GCP Guidelines
Desirable
- Experience of working in primary care preferred
- Experience of managing own workload as well as working well with others
- Experience of working on EMIS WEB
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.
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
Additional information
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.
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).