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 identify strategies to find and assist in the enrolment of research participants. The post-holder will perform a range of clinical assessments in line with accepted standards of practice. They will communicate effectively 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 and maintenance of databases. They will be responsible for ordering study supplies. The post holder will ensure the well-being of participants by adhering to relevant regulations and local Standard Operating Procedures (SOPs) including Good Clinical Practice (GCP), Medicines for Human Use (Clinical Trials) Regulations, Research Governance Framework for Health and Social Care and the Human Tissue Act.
Main duties of the job
The role will include screening and recruiting potential participants, collecting and maintaining study records, organising, collecting & processing patient samples and liaising with principal investigators and clinical staff to ensure safe and high-quality care for our patients and service users.
You will work closely with research nurses, principal investigators, the wider research delivery team including trial pharmacists.
You will:
Provide excellent care and ensure patients and participants come first.
Work within relevant regulations and ICH GCP (International Conference on Harmonisation and Good Clinical Practice) ensuring that the study protocol is adhered to at all times.
Co-ordinate research clinics and co-ordinate a portfolio of studies in conjunction with team members. This involves planning and organising clinical study related care or tests in accordance with approved study protocols or departmental standard operating procedures.
For specific studies post holder may be delegated to obtain consent from participants in line with Trust policy and research protocol.
Report any adverse events or health concerns which occur whilst the participant is taking part in the study, to an appropriate doctor or nurse in a timely manner and to the appropriate principal or co-investigator.
Perform and record a range of clinical assessments in line with personal competencies and as per study protocols.
About us
Our research programme is at the heart of everything we do at Guy's and St Thomas' NHS Foundation Trust, and plays a vital role in helping us to consolidate and grow on our position as one of the UK's leading research Trusts.There are excellent opportunities for further education and research development as part of these roles, with access to CPD funding and revalidation support. Opportunities for developing new research and clinical skills are available and actively encouraged. The normal working hours are Monday to Friday 9am-5pm, although the post holder will need to be flexible to accommodate patient visits and assessments outside of these hours when required.
Job description
Job responsibilities
Duties and 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 study protocol is adhered to at all times.
- Co-ordinate research clinics and co-ordinate a portfolio of studies in conjunction with team members. This involves planning and organising clinical study related care or tests in accordance with approved study protocols or departmental standard operating procedures.
- Establish 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 appointments and conduct telephone follow-up calls as required.
- Report any adverse events or health concerns which occur whilst the participant is taking part in the study, to an appropriate doctor or nurse in a timely manner and to the appropriate principal or co-investigator.
- Perform and record a range of clinical assessments in line with personal competencies and as stipulated in approved study protocols including blood pressure, temperature, respirations, questionnaires, urinalysis, weight and height, and report abnormalities or changes appropriately.
- Perform tasks requiring clinical and laboratory skills, including phlebotomy, venepuncture, biological sample preparation within clinical area and laboratories as stipulated in approved protocols and laboratory manuals.
- Responsible for ensuring safe and appropriate storage, shipment and documentation of specimens.
- Keep up to date with current practice for phlebotomy and venepuncture.
- Provide ongoing support to the participant and carer whilst participating in the clinical study.
- Communicate on a regular basis with senior medical staff, nursing, pharmacy, radiology, and pathology and laboratory staff.
- Liaise 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.
- Take responsibility for ensuring own knowledge of amendments and updates to studies you work on and assist the research team in ensuring that information relating to updates in the study protocols and guidelines are disseminated to key areas and personnel.
- 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 with external study coordinators and sponsor representatives, nationally and internationally.
- Send GP letters or other trial related material to relevant parties.
- Arrange, attend and record minutes for research and other relevant departmental meeting.
- Assist with the organisation and set up of selection and initiation and investigator meetings for studies.
- 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.
- Administration and maintenance of trial site files in coordination with sponsor representatives.
- 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 patients medical notes and study file is transcribed accurately.
- Responsible for the maintenance of Investigator Site Files.
- Create databases, validate and maintain them and ensure their security and compliance with the data protection act.
- Update and maintain centralised patient database.
- Deal effectively with queries relating to data and information in a timely and efficient manner.
- Assist in the creation and maintenance of good office systems for the smooth running of the service.
- Organise and prepare documentation for monitoring visits.
- Provide timely information and reports to reflect recruitment of patients including timely entry to EDGE according to team processes.
- Escalate any issues regarding data collection to the appropriate personnel.
- Assist sponsor and/or R&D with relevant essential documents at set up of a study.
- Assist in archiving processes for closed studies within the team.
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.
Education & Professional Development
- Take responsibility for identifying personal training and educational needs within the context of the service and those identified during the appraisal process.
- 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.
Other responsibilities
- Assist other members of the multidisciplinary team as required with all aspects of study delivery.
- Act always in a manner which, promotes positive working relationships and maintains the professional image of the Trust.
- Co-ordinate and supervise housekeeping duties and ordering of study supplies as requested.
- Responsibly assist in the management the control of equipment, resources and stock through the adherence of research policies and study budgets.
- Ensure own actions help to maintain quality.
- To work as a member of a multi-disciplinary team
- Work collaboratively with colleagues across R&D and wider GSTT to facilitate the achievement of objectives and shared learning.
Job description
Job responsibilities
Duties and 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 study protocol is adhered to at all times.
- Co-ordinate research clinics and co-ordinate a portfolio of studies in conjunction with team members. This involves planning and organising clinical study related care or tests in accordance with approved study protocols or departmental standard operating procedures.
- Establish 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 appointments and conduct telephone follow-up calls as required.
- Report any adverse events or health concerns which occur whilst the participant is taking part in the study, to an appropriate doctor or nurse in a timely manner and to the appropriate principal or co-investigator.
- Perform and record a range of clinical assessments in line with personal competencies and as stipulated in approved study protocols including blood pressure, temperature, respirations, questionnaires, urinalysis, weight and height, and report abnormalities or changes appropriately.
- Perform tasks requiring clinical and laboratory skills, including phlebotomy, venepuncture, biological sample preparation within clinical area and laboratories as stipulated in approved protocols and laboratory manuals.
- Responsible for ensuring safe and appropriate storage, shipment and documentation of specimens.
- Keep up to date with current practice for phlebotomy and venepuncture.
- Provide ongoing support to the participant and carer whilst participating in the clinical study.
- Communicate on a regular basis with senior medical staff, nursing, pharmacy, radiology, and pathology and laboratory staff.
- Liaise 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.
- Take responsibility for ensuring own knowledge of amendments and updates to studies you work on and assist the research team in ensuring that information relating to updates in the study protocols and guidelines are disseminated to key areas and personnel.
- 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 with external study coordinators and sponsor representatives, nationally and internationally.
- Send GP letters or other trial related material to relevant parties.
- Arrange, attend and record minutes for research and other relevant departmental meeting.
- Assist with the organisation and set up of selection and initiation and investigator meetings for studies.
- 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.
- Administration and maintenance of trial site files in coordination with sponsor representatives.
- 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 patients medical notes and study file is transcribed accurately.
- Responsible for the maintenance of Investigator Site Files.
- Create databases, validate and maintain them and ensure their security and compliance with the data protection act.
- Update and maintain centralised patient database.
- Deal effectively with queries relating to data and information in a timely and efficient manner.
- Assist in the creation and maintenance of good office systems for the smooth running of the service.
- Organise and prepare documentation for monitoring visits.
- Provide timely information and reports to reflect recruitment of patients including timely entry to EDGE according to team processes.
- Escalate any issues regarding data collection to the appropriate personnel.
- Assist sponsor and/or R&D with relevant essential documents at set up of a study.
- Assist in archiving processes for closed studies within the team.
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.
Education & Professional Development
- Take responsibility for identifying personal training and educational needs within the context of the service and those identified during the appraisal process.
- 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.
Other responsibilities
- Assist other members of the multidisciplinary team as required with all aspects of study delivery.
- Act always in a manner which, promotes positive working relationships and maintains the professional image of the Trust.
- Co-ordinate and supervise housekeeping duties and ordering of study supplies as requested.
- Responsibly assist in the management the control of equipment, resources and stock through the adherence of research policies and study budgets.
- Ensure own actions help to maintain quality.
- To work as a member of a multi-disciplinary team
- Work collaboratively with colleagues across R&D and wider GSTT to facilitate the achievement of objectives and shared learning.
Person Specification
Education/ Qualifications
Essential
- NVQ level 4 or equivalent qualification or qualified to NVQ3 or equivalent plus significant previous experience
Desirable
- Good Clinical Practice certificate
- Evidence of education related to clinical research
Previous experience
Essential
- Experience of working in a relevant healthcare or clinical research role with patient/public communication/ coordination duties OR biomedical degree and experience working in a relevant public facing role
- Experience of working in a team
- Experience using databases
Desirable
- Experience performing basic clinical tasks such as clinical observations (height, weight, blood pressure, pulse, temperature)
- Experience of caring for patients/participants in a professional setting.
- Experience of working on clinical trials of drugs, therapies or interventions.
Skills , knowledge and ability
Essential
- Ability to communicate well (written and verbally), with clear and legible handwriting
- Able to conduct clinical tasks such as blood pressure, temperature, pulse and respiratory observations
- Ability to acquire skills in phlebotomy and sample collection
- Ability to acquire basic laboratory skills
- IT skills, specifically in database management, Microsoft Office
Desirable
- Knowledge of mandatory standards for clinical research conduct (including GCP, UK Policy framework for Health and Social Care research, data protection)
Person Specification
Education/ Qualifications
Essential
- NVQ level 4 or equivalent qualification or qualified to NVQ3 or equivalent plus significant previous experience
Desirable
- Good Clinical Practice certificate
- Evidence of education related to clinical research
Previous experience
Essential
- Experience of working in a relevant healthcare or clinical research role with patient/public communication/ coordination duties OR biomedical degree and experience working in a relevant public facing role
- Experience of working in a team
- Experience using databases
Desirable
- Experience performing basic clinical tasks such as clinical observations (height, weight, blood pressure, pulse, temperature)
- Experience of caring for patients/participants in a professional setting.
- Experience of working on clinical trials of drugs, therapies or interventions.
Skills , knowledge and ability
Essential
- Ability to communicate well (written and verbally), with clear and legible handwriting
- Able to conduct clinical tasks such as blood pressure, temperature, pulse and respiratory observations
- Ability to acquire skills in phlebotomy and sample collection
- Ability to acquire basic laboratory skills
- IT skills, specifically in database management, Microsoft Office
Desirable
- Knowledge of mandatory standards for clinical research conduct (including GCP, UK Policy framework for Health and Social Care research, data protection)
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).
