Job summary
Acting as patient and participant advocate at all times, the post holder will be expected to co-ordinate research clinics and organise study related care. They will implement and evaluate strategies to identify and assist in the enrolment of research participants. The post-holder will lead on a portfolio of research studies and perform a range of clinical assessments in line with accepted standards of practice.
Main duties of the job
They will communicate proactively with the study and clinical teams to ensure good participant experience and adherence to study protocols. The post holder will be responsible for case report form completion, site file management, implementation of amendments and maintenance of databases. The post holder will process biologic samples according to protocols. They will act as mentor and support for new and junior team members. They will contribute to quality assurance processes within the team. The post holder will ensure the well-being of participants by adhering to study protocols, relevant regulations and local Standard Operating Procedures (SOPs).
About us
The NIHR Clinical Research Networks (CRN) were established by the Department of Health to improve the speed, quality and integration of clinical research, resulting in improved patient care. They are managed by the NIHR Clinical Research Network Coordinating Centre, based in Leeds and London. The NIHR CCRN comprises 15 Geographical Local research networks (LRNs) in England, Each local Clinical Research Network is structured within 6 Divisions which delivers research across 30 clinical specialties.
The role of the LRNs is to establish and maintain an excellent NHS infrastructure for clinical research and research management. This infrastructure includes clinical research support staff and sessional support for clinical investigators of all professions, funding for other NHS Support Costs such as additional clinical services and diagnostic tests, and research management and governance systems and staff.
The Gastrointestinal Medicine and Surgery research team delivers studies across the multidisciplinary gastrointestinal department. The team is made up of Principal Investigators and sub-investigators, Research Nurses and Clinical Research Practitioners who work together to deliver studies to high standards.
Job description
Job responsibilities
Clinical and Communication Responsibilities
- Provide excellent customer care skills to ensure patients and participants come first.
- Work within relevant regulations and ICH GCP (International Conference on Harmonisation and Good Clinical Practice) ensuring that the clinical trial protocol is adhered to at all times.
- Lead on a portfolio of trials and coordinate participation. This requires liaising with the clinical team to organise and ensure that trial specific investigations are undertaken according to the protocol, paying particular attention to accurate data collection and dissemination and version control of essential documentation.
- Devise, implement and evaluate strategies for recruiting participants into clinical studies and identify individuals potentially eligible for research studies. Gain permissions for research contacts.
- For specific studies post holder may be delegated to obtain consent from participants in line with Trust policy and research protocol.
- Organise and facilitate participant appointments and follow-up phone calls.
- Accurately perform and record observations of clinical activities required according to personal competencies and the study protocol and obtain the results including blood pressure, temperature, respirations, questionnaires, urinalysis, weight and height, and report abnormalities or changes appropriately.
- Report any adverse events or health concerns which occur whilst the participant is taking part in the study to the appropriate doctor or nurse in a timely manner, and to the appropriate principal or co-investigator.
- Liaise with pharmacy to co-ordinate the availability and dispensing of study drugs if appropriate.
- Perform tasks requiring clinical and laboratory skills, including phlebotomy, venepuncture, tissue and blood sample preparation within clinic and laboratory in line with personal competencies and approved study protocol
- Process biological samples according to personal competencies and the study-specific protocol and laboratory manual and organise the storage, shipment and documentation of samples.
- Provide ongoing support to the participant and carer whilst participating in the clinical study.
- Communicate study related information effectively with the research team and study participants and their family members. This information may be complex or sensitive, and there may be barriers to understanding.
- Communicate effectively and efficiently specialised advice pertaining to research protocols to members of the multidisciplinary team.
- Engage effectively with other departments and wards at the site/s, in order to promote a good working environment, integration of research and open channels of communication.
- Communicate with external study coordinators and sponsor representatives, nationally and internationally.
- Attend and participate in departmental meetings and help promote new ideas and methods and assist in their implementation.
- Attend and participate in multidisciplinary team meetings.
- Arrange, attend and record minutes for research and other relevant departmental meeting.
- Attend national and international study specific meetings and disseminate information to members of the multi-disciplinary team as required.
Information and data management
- Update participant study and medical records to accurately document study related activity and procedures.
- Ensure the confidentiality of verbal, written and computerised information.
- Complete case report forms in a precise and timely manner, ensuring that all the relevant clinical data in the participants medical notes and study file is transcribed accurately.
- Responsible for the maintenance of the Investigator Site Files.
- Aid with local study set up to ensure all applicable documents are ready to use once relevant approvals are received. Organise study set up visits, involving all relevant departments.
- Create databases, validate and maintain them and ensure their security and compliance with the data protection act.
- Update and maintain centralised database.
- Responsible for ensuring that all data queries are dealt with in a timely and efficient manner.
- Assist in the creation and maintenance of good office systems for the smooth running of the service.
- Plan, prepare documentation and participate in audit and monitoring visits.
- Implement strategies to ensure full and accurate data-set for all study participants.
- Process amendments according to standard operating procedure as received in a timely manner.
- Collate data and compile reports for the Clinical Lead, Research Managers and commercial sponsors as required.
- Provide timely information and reports to reflect recruitment of patients including timely entry to EDGE according to team processes.
Management and leadership
- Provide advice and training to colleagues as relevant to your role.
- Supervise, train or mentor new or more junior staff as required.
- Act as a role model, giving guidance, counselling and support to new and junior staff.
- Actively contribute to the teaching programme within the department.
Education and Professional development
- Take responsibility for identifying personal training and educational needs within the context of the service and those identified during the appraisal process.
- To maintain an up to date knowledge relevant to the specialty and research.
- Act in accordance with the Health Education England (HEE) Care Certificate framework standards at all times.
- Undertake an Individual Performance Review annually with your Line Manager.
- Maintain a record to reflect any training carried out pertaining to the post.
Other responsibilities
- Act always in a manner which, promotes positive working relationships and maintains the professional image of the Trust.
- Responsibly manage the control of equipment, resources and stock.
- Actively seek to develop the role to take account of changing requirements of the service.
- Ensure own actions help to maintain quality.
- To work as a member of a multi-disciplinary team.
- Work collaboratively with colleagues across R&D, NIHR BRC and wider GSTFT to facilitate the achievement of objectives and shared learning.
Job description
Job responsibilities
Clinical and Communication Responsibilities
- Provide excellent customer care skills to ensure patients and participants come first.
- Work within relevant regulations and ICH GCP (International Conference on Harmonisation and Good Clinical Practice) ensuring that the clinical trial protocol is adhered to at all times.
- Lead on a portfolio of trials and coordinate participation. This requires liaising with the clinical team to organise and ensure that trial specific investigations are undertaken according to the protocol, paying particular attention to accurate data collection and dissemination and version control of essential documentation.
- Devise, implement and evaluate strategies for recruiting participants into clinical studies and identify individuals potentially eligible for research studies. Gain permissions for research contacts.
- For specific studies post holder may be delegated to obtain consent from participants in line with Trust policy and research protocol.
- Organise and facilitate participant appointments and follow-up phone calls.
- Accurately perform and record observations of clinical activities required according to personal competencies and the study protocol and obtain the results including blood pressure, temperature, respirations, questionnaires, urinalysis, weight and height, and report abnormalities or changes appropriately.
- Report any adverse events or health concerns which occur whilst the participant is taking part in the study to the appropriate doctor or nurse in a timely manner, and to the appropriate principal or co-investigator.
- Liaise with pharmacy to co-ordinate the availability and dispensing of study drugs if appropriate.
- Perform tasks requiring clinical and laboratory skills, including phlebotomy, venepuncture, tissue and blood sample preparation within clinic and laboratory in line with personal competencies and approved study protocol
- Process biological samples according to personal competencies and the study-specific protocol and laboratory manual and organise the storage, shipment and documentation of samples.
- Provide ongoing support to the participant and carer whilst participating in the clinical study.
- Communicate study related information effectively with the research team and study participants and their family members. This information may be complex or sensitive, and there may be barriers to understanding.
- Communicate effectively and efficiently specialised advice pertaining to research protocols to members of the multidisciplinary team.
- Engage effectively with other departments and wards at the site/s, in order to promote a good working environment, integration of research and open channels of communication.
- Communicate with external study coordinators and sponsor representatives, nationally and internationally.
- Attend and participate in departmental meetings and help promote new ideas and methods and assist in their implementation.
- Attend and participate in multidisciplinary team meetings.
- Arrange, attend and record minutes for research and other relevant departmental meeting.
- Attend national and international study specific meetings and disseminate information to members of the multi-disciplinary team as required.
Information and data management
- Update participant study and medical records to accurately document study related activity and procedures.
- Ensure the confidentiality of verbal, written and computerised information.
- Complete case report forms in a precise and timely manner, ensuring that all the relevant clinical data in the participants medical notes and study file is transcribed accurately.
- Responsible for the maintenance of the Investigator Site Files.
- Aid with local study set up to ensure all applicable documents are ready to use once relevant approvals are received. Organise study set up visits, involving all relevant departments.
- Create databases, validate and maintain them and ensure their security and compliance with the data protection act.
- Update and maintain centralised database.
- Responsible for ensuring that all data queries are dealt with in a timely and efficient manner.
- Assist in the creation and maintenance of good office systems for the smooth running of the service.
- Plan, prepare documentation and participate in audit and monitoring visits.
- Implement strategies to ensure full and accurate data-set for all study participants.
- Process amendments according to standard operating procedure as received in a timely manner.
- Collate data and compile reports for the Clinical Lead, Research Managers and commercial sponsors as required.
- Provide timely information and reports to reflect recruitment of patients including timely entry to EDGE according to team processes.
Management and leadership
- Provide advice and training to colleagues as relevant to your role.
- Supervise, train or mentor new or more junior staff as required.
- Act as a role model, giving guidance, counselling and support to new and junior staff.
- Actively contribute to the teaching programme within the department.
Education and Professional development
- Take responsibility for identifying personal training and educational needs within the context of the service and those identified during the appraisal process.
- To maintain an up to date knowledge relevant to the specialty and research.
- Act in accordance with the Health Education England (HEE) Care Certificate framework standards at all times.
- Undertake an Individual Performance Review annually with your Line Manager.
- Maintain a record to reflect any training carried out pertaining to the post.
Other responsibilities
- Act always in a manner which, promotes positive working relationships and maintains the professional image of the Trust.
- Responsibly manage the control of equipment, resources and stock.
- Actively seek to develop the role to take account of changing requirements of the service.
- Ensure own actions help to maintain quality.
- To work as a member of a multi-disciplinary team.
- Work collaboratively with colleagues across R&D, NIHR BRC and wider GSTFT to facilitate the achievement of objectives and shared learning.
Person Specification
Qualifications/ Education
Essential
- Degree in life sciences or related field or equivalent theoretical knowledge
- GCP certification
Desirable
- Relevant course to clinical area
Previous experience
Essential
- Experience of working in a relevant research setting
- Experience of working in a patient/participant facing role with clinical duties
- Experience of working on interventional studies or complex/ large scale observational studies'
Desirable
- Experience with electronic case report forms and computer packages
- Experience of working on clinical trials of drugs, therapies or interventions
Skills/Knowledge/ Ability
Essential
- IT skills, specifically in database management, Microsoft, Excel and eRecord
- Up to date knowledge relevant to clinical research and good clinical practice
Desirable
- Proficient in cannulation and serial sampling.
Person Specification
Qualifications/ Education
Essential
- Degree in life sciences or related field or equivalent theoretical knowledge
- GCP certification
Desirable
- Relevant course to clinical area
Previous experience
Essential
- Experience of working in a relevant research setting
- Experience of working in a patient/participant facing role with clinical duties
- Experience of working on interventional studies or complex/ large scale observational studies'
Desirable
- Experience with electronic case report forms and computer packages
- Experience of working on clinical trials of drugs, therapies or interventions
Skills/Knowledge/ Ability
Essential
- IT skills, specifically in database management, Microsoft, Excel and eRecord
- Up to date knowledge relevant to clinical research and good clinical practice
Desirable
- Proficient in cannulation and serial sampling.
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).
