Job summary
The NHS is the biggest employer in Europe. It's a world-renowned institution and an exciting place to work, full of challenges and opportunities.
The Robert Jones and Agnes Hunt Orthopaedic Hospital (RJAH) is one of the leading specialist orthopaedic hospitals in the country, with some of the highest levels of staff and patient satisfaction, as well as a strong reputation for innovation. We work together as a team of over 1,600 expert members of staff to make a difference for our patients and their families.
Our latest CQC Report was published in February 2019 and saw us rated as 'Good' overall and 'Outstanding' for care.
Who we're looking for...
Study Support Officer
The aim of the role is to provide a project support function to ensure the delivery of high quality clinical trials and research. The post holder will provide support to the Senior Study Support Officer(s), Project Manager(s) and Research Delivery Staff to ensure the timely delivery of research studies being conducted. This will include assisting with the preparation and completion of regulatory and funding applications, feasibility forms, co-ordination of patients, data collection, reporting adverse events, trial coordination and data entry and management.
Main duties of the job
A full explanation of the main duties of the role can be found in the job description. They include:
- Ability to read and understand scientific text, including sometimes complex study protocols, and be able to relay this information using lay terminology, in order to assist in the preparation of application forms for regulatory approval, patient information leaflets, consent forms and newsletters etc.
- Occasional need to support the research team in the identification and consenting of patients into non-interventional trials by providing detailed information in lay terminology to enable the patient to make an informed decision as to whether they participate in a study or not.
- Maintain regular communication with all members of the Trust research team, Trust service support teams, external collaborators, networks and sponsors as necessary.
- Liaise with the sponsor CRAs and/or monitors during the conduct of a trial under the advisement of more senior research staff
- Assist with data collection and data entry, responding to data queries and alerting the study team to missing or incomplete data and appropriately escalating concerns over patient safety or data quality.
- Assist in the creation and maintenance of spreadsheets and databases to track study recruitment and completion of study visits to assist the clinical delivery team in meeting study timelines and to inform progress reports for the project managers and research leads.
About us
Our aim is to aspire to deliver world class patient care, and we want talented, dedicated and passionate people to help us achieve this.
Our continued success is accomplished through the skills and expertise of our staff, which is underpinned by our values: Friendly, Caring, Excellence, Professional and Respect. If your values align to ours, and you would like to join us in aspiring to deliver world class patient care, we would love to hear from you.
Joining RJAH is more than just a job - we want our people to have the best opportunities to thrive in their role.
Whether you're starting out in your career, or have a wealth of experience - we're always looking to recruit outstanding individuals in a range of clinical areas, as well as support and administrative roles.
We have a range of fantastic staff benefits on offer to everyone who joins RJAH and you'll have access to state-of-the-art facilities and outstanding professional development opportunities.
RJAH has strong links with a range of universities including Staffordshire, Keele, Glyndwr, Chester and Birmingham.
Shropshire is also one of the most attractive parts of the country, with a rich historic culture and excellent transport links. The hospital is located on a site outside Oswestry, just off the A5. The nearest train station is in Gobowen, approximately two miles from the hospital. The station is part of the Chester to Birmingham line.
Job description
Job responsibilities
Duties and Responsibilities
Communication and Relationship Skills:
Ability to read and understand scientific text, including sometimes complex study protocols, and be able to relay this information using lay terminology, in order to assist inthe preparation of application forms for regulatory approval, patient information leaflets, consent forms and newsletters etc. Occasional need to support the research team in the consenting of patients into noninterventional trials by providing detailed information in lay terminology to enable the patient to make an informed decision as to whether they participate in a study or not. Maintain regular communication with all members of the Trust research team, Trust service support teams, external collaborators, networks and sponsors as necessary. Liaise with the sponsor CRAs and/or monitors during the conduct of a trial under the advisement of more senior research staff Assist senior research staff in the training of staff and educating patients involved in research projects and trials Assist in the preparation of materials for and participating in conferences, seminars and other educational meetings as appropriate. Provide feedback to research and all clinicalstaff on completion of a trial etc. Undertake educational activities to develop skills and knowledge as required for this post.
Analytical and Judgement Skills:
Able to read, understand and interpret complex study protocols. Assist in the identification of patients suitable for recruitment into trials using trial specific inclusion and exclusion criteria Assist with data collection and data entry, responding to data queries and alerting the study team to missing or incomplete data and appropriately escalating concerns overpatient safety or data quality.
Provide advice where able to patients during face-to-face consultations and via the telephone, seeking further advice from the senior research team, trial investigators andsponsors where appropriate
Planning and Organisational Tasks:
Assist the Senior Study Support Officer and Project Manager in the organisation and submission of documents required for Health Research Authority (HRA) approval, Trust support services feasibility and agreement and overall Trust agreement for the conduct of the study. Assist in the maintenance of trial master files, investigator site files, and day to day project administration and document control in line with the current regulations Create and maintain study records on the local project management system, thus providing information to the NIHR and CRN as requested in a timely manner meeting alldeadlines Assist in the creation and maintenance of spreadsheets and databases to track study recruitment and completion of study visits to assist the clinical delivery team in meetingstudy timelines and to inform progress reports for the project managers and research leads. Assist with the coordination of study team meetings during study set-up and throughout the course of a project Assist with the arrangement of study visits to ensure that all assessments can be completed. This can involve liaising with multiple departments across the Trust, arrangingfor paperwork to be signed by clinical staff, booking clinic space, making travel arrangements, sending and receiving specimen tubes, and alerting clinical staff who maynot be part of the research team. Liaise with the research team to set timescales and resolve problems to meet deadlines Assist in the archiving process of research data and documents in line with national and local regulations.
Patient/Client Tasks: Attending clinics in which the researching consultant anticipates screening potential patients for a specific clinical trial. Examination of medical records, waiting lists andadmission activity. Contact research participants by telephone or letter as appropriate with details of study visits as per trial protocol.
Policy and Service Development: Compliance with Trust procedures and polices Compliance with the UK Policy Framework for Health and Social Care Research and the EU Directive for Clinical Trials Provide input into local and Trust research related policies
Responsibility for Financial/Physical Resources: Provide information re patient expenses where appropriate
Responsibility for Information Resources: Monitor progress of patient recruitment via electronic databases and spreadsheets where appropriate Collection of data in trial specific case report forms (CRFs) with the appropriate supervision. This information can be complex at times. Ensure accurate and complete trial data is collected by auditing against patient notes where applicable Ensure accurate entry of trial data onto the research databases including external databases
Responsibility for Human Resources:
Liaise with the Senior Study Support Officer, Project Manager, Clinical Delivery Team and administrative support
Responsibility for Research and Development: To provide support for individual research studies being run within the Trust. This may involve working on more than one project at any time under the supervision of a moresenior member of the research team Responsible for the day-to-day co-ordination and management of research projects being undertaken at RJAH using specific and predetermined complex trial protocols
Job description
Job responsibilities
Duties and Responsibilities
Communication and Relationship Skills:
Ability to read and understand scientific text, including sometimes complex study protocols, and be able to relay this information using lay terminology, in order to assist inthe preparation of application forms for regulatory approval, patient information leaflets, consent forms and newsletters etc. Occasional need to support the research team in the consenting of patients into noninterventional trials by providing detailed information in lay terminology to enable the patient to make an informed decision as to whether they participate in a study or not. Maintain regular communication with all members of the Trust research team, Trust service support teams, external collaborators, networks and sponsors as necessary. Liaise with the sponsor CRAs and/or monitors during the conduct of a trial under the advisement of more senior research staff Assist senior research staff in the training of staff and educating patients involved in research projects and trials Assist in the preparation of materials for and participating in conferences, seminars and other educational meetings as appropriate. Provide feedback to research and all clinicalstaff on completion of a trial etc. Undertake educational activities to develop skills and knowledge as required for this post.
Analytical and Judgement Skills:
Able to read, understand and interpret complex study protocols. Assist in the identification of patients suitable for recruitment into trials using trial specific inclusion and exclusion criteria Assist with data collection and data entry, responding to data queries and alerting the study team to missing or incomplete data and appropriately escalating concerns overpatient safety or data quality.
Provide advice where able to patients during face-to-face consultations and via the telephone, seeking further advice from the senior research team, trial investigators andsponsors where appropriate
Planning and Organisational Tasks:
Assist the Senior Study Support Officer and Project Manager in the organisation and submission of documents required for Health Research Authority (HRA) approval, Trust support services feasibility and agreement and overall Trust agreement for the conduct of the study. Assist in the maintenance of trial master files, investigator site files, and day to day project administration and document control in line with the current regulations Create and maintain study records on the local project management system, thus providing information to the NIHR and CRN as requested in a timely manner meeting alldeadlines Assist in the creation and maintenance of spreadsheets and databases to track study recruitment and completion of study visits to assist the clinical delivery team in meetingstudy timelines and to inform progress reports for the project managers and research leads. Assist with the coordination of study team meetings during study set-up and throughout the course of a project Assist with the arrangement of study visits to ensure that all assessments can be completed. This can involve liaising with multiple departments across the Trust, arrangingfor paperwork to be signed by clinical staff, booking clinic space, making travel arrangements, sending and receiving specimen tubes, and alerting clinical staff who maynot be part of the research team. Liaise with the research team to set timescales and resolve problems to meet deadlines Assist in the archiving process of research data and documents in line with national and local regulations.
Patient/Client Tasks: Attending clinics in which the researching consultant anticipates screening potential patients for a specific clinical trial. Examination of medical records, waiting lists andadmission activity. Contact research participants by telephone or letter as appropriate with details of study visits as per trial protocol.
Policy and Service Development: Compliance with Trust procedures and polices Compliance with the UK Policy Framework for Health and Social Care Research and the EU Directive for Clinical Trials Provide input into local and Trust research related policies
Responsibility for Financial/Physical Resources: Provide information re patient expenses where appropriate
Responsibility for Information Resources: Monitor progress of patient recruitment via electronic databases and spreadsheets where appropriate Collection of data in trial specific case report forms (CRFs) with the appropriate supervision. This information can be complex at times. Ensure accurate and complete trial data is collected by auditing against patient notes where applicable Ensure accurate entry of trial data onto the research databases including external databases
Responsibility for Human Resources:
Liaise with the Senior Study Support Officer, Project Manager, Clinical Delivery Team and administrative support
Responsibility for Research and Development: To provide support for individual research studies being run within the Trust. This may involve working on more than one project at any time under the supervision of a moresenior member of the research team Responsible for the day-to-day co-ordination and management of research projects being undertaken at RJAH using specific and predetermined complex trial protocols
Person Specification
Qualifications
Essential
Desirable
- GCP Certification
- Degree (undergraduate)
Experience
Essential
Skills
Essential
- Computer literate
- Organisational skills
Knowledge
Essential
- Understanding of Clinical Research
personal qualities
Essential
- Good communication skills
Person Specification
Qualifications
Essential
Desirable
- GCP Certification
- Degree (undergraduate)
Experience
Essential
Skills
Essential
- Computer literate
- Organisational skills
Knowledge
Essential
- Understanding of Clinical Research
personal qualities
Essential
- Good communication skills
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).
Employer details
Employer name
Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Address
The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS FT
Oswestry
SY10 7AG
Employer's website
https://www.rjah.nhs.uk/ (Opens in a new tab)
