Job summary
Come and join our Haematology Research Team!!
We are seeking an enthusiastic and motivated Clinical Trials Officer to join our haematology research team at Southmead Hospital.
The post requires an enthusiastic individual to work alongside the haematology research nurses and haematologists to support the delivery of our varied and growing trials portfolio.
The successful post holder will be responsible for the routine day-to-day administration of research studies and their associated work to facilitate the optimum recruitment of patients to clinical trials.
We are offering:
- a job within an innovative and highly effective team
- an opportunity to be part of the NBT Research Infrastructure of >180 people
- a supportive training and development environment
Main duties of the job
The Clinical Trials Officer will,
- attend MDT meetings as required by the senior research nurse to support the caseload management of this team and recruitment into clinical trials
- provide individual care as specified within research protocols for simple studies to include genetic and questionnaire studies
-
assist in submitting requests to authorities in order to gain all appropriate approvals necessary to allow research to be undertaken in accordance with ICH GCP including UK Statutory instruments, ISO14155, local, national and international legislation
The post holder will be competent to work across professional disciplines, referring patients for assessment and treatment as required. They will collaborate with all team members, including other clinical staff, R&D and outside agencies.
About us
North Bristol NHS Trust employs over 12,000 staff providing healthcare to the residents of Bristol, South Gloucestershire and North Somerset from our award-winning hospital building at Southmead. We are the regional Major Trauma Centre, and an internationally recognised centre of excellence in a range of services and major specialities. Our vision is that by enabling our teams to be the best that they can be, we will provide exceptional healthcare, personally delivered.
We commit to treating each patient as an individual with respect and dignity, aiming to deliver excellent clinical outcomes and a first-class experience for everyone who uses our services.
North Bristol NHS Trust values all people as individuals. We aim to be an anti-discriminatory organisation and are committed to building a team that represents a variety of backgrounds, perspectives, and skills. We welcome applicants from all underrepresented groups.
The post holder will be employed by the Research & Development Department of North Bristol Trust. Research and Innovation have recently been awarded Silver accreditation with "Investors in People" which underlines our commitment to support and lead our staff to be the best they can be.
Job description
Job responsibilities
Study set up
- Provide support to Principal Investigator and senior research nurse to set up appropriate research management systems to comply with ICH-GCP, ISO 14155, local, national and international policies and legislation.
- Provide information and practical support to clinical investigators on study feasibility, ethical approval procedures and research governance.
- Co-ordinate and manage the exchange of information between the study co-ordinating centre, clinical departments and Research & Innovation department.
- Ensure all relevant information is submitted to R&I to enable approval checks on all relevant studies requesting access to NHS patients, staff or premises
- Support the research team to undertake detailed costing of future studies, identifying all costs generated by the study
- Complete appropriate databases to record patients recruited to trials, track their visits and submit information to finance department who invoice for commercial studies.
- Prepare and collate relevant materials for study visits including blood/tissue collection tubes and mailing boxes.
- Review protocols for trials in order to prepare appropriate labels, clinic sheets and study forms on Trust headed paper, for use during the trial.
- Set up site initiation visits with study co-ordinators and the research team.
Study running
- Maintain Site Files and Case Report Files for all studies in accordance with ICH-GCP, ISO 14155, local, national and international policies and legislation.
- Liaise with clinical and clinical support departments to facilitate the commencement, execution and completion of studies
- Ensure the accuracy and integrity of the information recorded on site files, case report files databases etc
- Assist the research team by preparing and collating relevant documentation and equipment for each study visit.
- Attend MDT meetings as required by the senior research nurse to support the caseload management of this team and recruitment into clinical trials
- Undertake and interpret a range of patient observations as required e.g. temperature, pulse, respiration, blood pressure, early warning score, oxygen saturation levels, ECG. Report adverse signs to registered Nurse / Doctor.
- Undertake a range of procedures relevant to area of work e.g. venepuncture, cannulation and dressings.
- Escort patients to departments within North Bristol NHS Trust.
- Work closely with the research nurses, organising follow-up visits with patients and investigations as requested and in accordance with trial protocols.
- Communicate with patients in a clear and professional manner; ensuring that the patient understands the information they have been given.
- Submit recruitment figures on a monthly basis to NBT accruals administrator or equivalent.
- Prepare reports for R&I pertaining to research productivity
- Ensure that all research and information governance policies are adhered to and that all data is handled in accordance with the Data Protection Act 1998.
- Conduct queries in Access databases when data is requested by the research team
- Assist in organising meetings for the research team and take minutes.
- Track incoming and outgoing payments and update visit payment trackers.
- Arrange couriering of samples and other study related material.
- Maintain sufficient stocks of study supplies.
Study end
- Assist with archiving at study closure.
Education
- The post holder should be able to identify own learning needs, seek educational opportunities and ensure attendance at all mandatory training sessions
- The post holder would need to be willing to travel to study related meetings and training courses in the UK as part of this role.
Other
- Exhibit professional behaviour and attitude at all times
- Recognise own level of competence to ensure safe practice
- Be familiar with and abide by Trust policies, procedures and research standardoperating procedures (SOPs) to ensure to ensure optimum patient care, data integrity and the safety of patients and staff
- Act as a role model by upholding and implementing good practice in the workplace, always ensuring the highest standards of evidenced based care
Job description
Job responsibilities
Study set up
- Provide support to Principal Investigator and senior research nurse to set up appropriate research management systems to comply with ICH-GCP, ISO 14155, local, national and international policies and legislation.
- Provide information and practical support to clinical investigators on study feasibility, ethical approval procedures and research governance.
- Co-ordinate and manage the exchange of information between the study co-ordinating centre, clinical departments and Research & Innovation department.
- Ensure all relevant information is submitted to R&I to enable approval checks on all relevant studies requesting access to NHS patients, staff or premises
- Support the research team to undertake detailed costing of future studies, identifying all costs generated by the study
- Complete appropriate databases to record patients recruited to trials, track their visits and submit information to finance department who invoice for commercial studies.
- Prepare and collate relevant materials for study visits including blood/tissue collection tubes and mailing boxes.
- Review protocols for trials in order to prepare appropriate labels, clinic sheets and study forms on Trust headed paper, for use during the trial.
- Set up site initiation visits with study co-ordinators and the research team.
Study running
- Maintain Site Files and Case Report Files for all studies in accordance with ICH-GCP, ISO 14155, local, national and international policies and legislation.
- Liaise with clinical and clinical support departments to facilitate the commencement, execution and completion of studies
- Ensure the accuracy and integrity of the information recorded on site files, case report files databases etc
- Assist the research team by preparing and collating relevant documentation and equipment for each study visit.
- Attend MDT meetings as required by the senior research nurse to support the caseload management of this team and recruitment into clinical trials
- Undertake and interpret a range of patient observations as required e.g. temperature, pulse, respiration, blood pressure, early warning score, oxygen saturation levels, ECG. Report adverse signs to registered Nurse / Doctor.
- Undertake a range of procedures relevant to area of work e.g. venepuncture, cannulation and dressings.
- Escort patients to departments within North Bristol NHS Trust.
- Work closely with the research nurses, organising follow-up visits with patients and investigations as requested and in accordance with trial protocols.
- Communicate with patients in a clear and professional manner; ensuring that the patient understands the information they have been given.
- Submit recruitment figures on a monthly basis to NBT accruals administrator or equivalent.
- Prepare reports for R&I pertaining to research productivity
- Ensure that all research and information governance policies are adhered to and that all data is handled in accordance with the Data Protection Act 1998.
- Conduct queries in Access databases when data is requested by the research team
- Assist in organising meetings for the research team and take minutes.
- Track incoming and outgoing payments and update visit payment trackers.
- Arrange couriering of samples and other study related material.
- Maintain sufficient stocks of study supplies.
Study end
- Assist with archiving at study closure.
Education
- The post holder should be able to identify own learning needs, seek educational opportunities and ensure attendance at all mandatory training sessions
- The post holder would need to be willing to travel to study related meetings and training courses in the UK as part of this role.
Other
- Exhibit professional behaviour and attitude at all times
- Recognise own level of competence to ensure safe practice
- Be familiar with and abide by Trust policies, procedures and research standardoperating procedures (SOPs) to ensure to ensure optimum patient care, data integrity and the safety of patients and staff
- Act as a role model by upholding and implementing good practice in the workplace, always ensuring the highest standards of evidenced based care
Person Specification
Education/Training/Qualifications
Essential
- NVQ in Health, Social Science or science
Desirable
- Foundation Degree in Health, Social Science or Science
Work Experience
Essential
- Use of all Microsoft Office programs with ability to create and manipulate Excel spread sheets
- Project management experience
- Experience of working to protocols and procedures
Desirable
- Previous experience of working within a healthcare/caring environment
Knowledge/Skills/Abilities
Essential
- Understanding of patient confidentiality / Data Protection
- Willingness to learn new skills
- Clerical and IT skills to include typing and minute taking at meetings
- Work well under pressure
Desirable
- Research Experience
- Knowledge of medical terminology
- Awareness of current policy issues in health services, research and its governance
Personal Qualities
Essential
- Evidence of continuing professional development
- Ability to use initiative and judgement in dealing with non-routine enquiries and situations
Person Specification
Education/Training/Qualifications
Essential
- NVQ in Health, Social Science or science
Desirable
- Foundation Degree in Health, Social Science or Science
Work Experience
Essential
- Use of all Microsoft Office programs with ability to create and manipulate Excel spread sheets
- Project management experience
- Experience of working to protocols and procedures
Desirable
- Previous experience of working within a healthcare/caring environment
Knowledge/Skills/Abilities
Essential
- Understanding of patient confidentiality / Data Protection
- Willingness to learn new skills
- Clerical and IT skills to include typing and minute taking at meetings
- Work well under pressure
Desirable
- Research Experience
- Knowledge of medical terminology
- Awareness of current policy issues in health services, research and its governance
Personal Qualities
Essential
- Evidence of continuing professional development
- Ability to use initiative and judgement in dealing with non-routine enquiries and situations
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.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
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.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
