Job summary
Do you want to make a difference?
Are you looking for a new and different career pathway or wish to expand your experience?
If so, we have an exciting opportunity for a Clinical Trials Assistant based in the Oncology Department, within Research and Innovation Department, Portsmouth Hospitals University NHS Trust.
The Oncology Research Department is nationally and internationally recognised as a leading centre, giving patient's in Portsmouth the possibility of receiving Cancer Treatments not yet available in the NHS.
A Clinical Trials Assistant has the opportunity to support the recruitment and delivery of different cancer trials, at different stages, which offers variety and a quicker understating of the research process. This role will involve working clinically with the multi-disciplinary team and include face-to-face interaction with patients, data entry and administrative work which are are an equally important part of this role. If you have experience of care, working with people, good time management, organisational skills, and like to do a bit of everything, then this job is for you.
Main duties of the job
- To contribute to maintaining a high standard of day-to-day clinical care for all patients eligible for and recruited into Clinical Trials within the departments.
- To recruit patients into Clinical Trials designated as 'portfolio' studies by the NIHR Clinical Research Network.
- To work as part of a team to deliver Clinical Trials within Portsmouth Hospitals University NHS Trust, providing both clinical and data management support for clinical trial activities undertaken at PHU.
- Work alongside the clinical team to coordinate and setup new clinical trials, ensuring accurate recording of patient data onto trial case reporting forms and databases.
- To provide support to the study Research Team and ultimately the Trust Director of Research in delivering high quality clinical research.
- Ensure research participant safety is maintained and participant experience is positive by treating all participants, relatives, colleagues with respect, dignity, and courtesy in accordance with Trust values.
- Support the Trust culture of collaborative, flexible cross-team working and commitment to delivering quality services and outcomes, which support the Government's policies on public health.
- The expectations within this job description will be achieved through hands-on clinical practice, education and training e.g. Phlebotomy, patient care procedures and specimen collection.
About us
Here at Portsmouth Hospitals University NHS Trust, we are proud to provide expert, compassionate care for our local population. We are ranked as the third in the country for research, embedding education and training across the organisation. Our main hub is the Queen Alexandra Hospital, which is one of the largest hospitals on the south coast employing over 8,700 staff.
Our patients come from all walks of life and so do we. We hire great people from a wide variety of backgrounds because it makes our hospital stronger. If you share our values and our enthusiasm for getting it right for patients, colleagues, and our community, you will find a home at Portsmouth Hospitals University NHS Trust.
Job description
Job responsibilities
Research, Patient Experience and Use of Resources
- To contribute to the co-ordination of Clinical Trial activities within the relevant departments.
- To assist with reviewing new Trial protocols and contribute to the assessment of their clinical and practical implications (including feasibility and risk) to local patients and the relevant departments.
- Receive consent from research participants into low-risk research trials with oversight from your line manager and senior colleagues.
- To provide clinical and admin support for a number of clinical trial protocols
- Assist in the identification, screening, and assessment of the suitability of local patients to take part in Clinical Trials, in accordance with specified inclusion/exclusion criteria.
- To provide information to patients about participating in clinical trials, including the risks and benefits of participation and to facilitate the process of gaining their informed consent under the supervision of Research Nurses and Principal Investigators.
- With appropriate training and oversight, undertake trial specific sampling as required by the protocol, to support the team to establish the eligibility of patients and to ensure their safe entry into and participation in clinical trials.
- To act as a contact for clinical trial patients within the relevant department and to be a resource for these patients and their families with respect to trial activities.
- Promoting research at ward level, encouraging staff to support research in order to aid recruitment.
- To maintain accurate documentation in an auditable format and accurately record data as required by each trial, including transcribing, and exporting data from medical records and hospital IT systems to clinical trial case report forms (CRFs) as required by trial protocols.
- To ensure the timely submission of accurate and completed CRFs to the trial co-ordinating centre and providing expedited responses to data queries and nonsensical information.
- To use trial internet-based databases and software to organise, report, record and monitor trial activities, including updating details of patients screened and recruited into clinical trials.
- To schedule clinic appointments for trial follow-up visits and refer patients for the relevant investigations as determined by the relevant trial protocol.
- Contribute to the person-centred care of patients in clinical trials; initiating investigations where appropriate and referring to Research Nurses or the Principal Investigator where necessary.
- Provide general administrative support to clinical trials, including filing, typing, fielding telephone calls, ordering patient notes and retrieving patient test results via hospital IT systems.
- Make arrangements for pathological samples, radiological films and electronic data to be sent for central review.
- Support the clinical research teams in preparing trial documentation for monitoring visits from trial sponsors and regulatory agencies.
- To work to Standard Operating Procedures for clinical trials set by the Trust and trial co-ordinators.
- To ensure all activities undertaken meet the standards set out by the Principles of Good Clinical Practice and National Research Governance Framework for Health and Social Care and adhere to all applicable regulatory requirements.
- May be required to work unsocial hours as necessary dependent on the needs of the service.
- May be required to work across more than one location e.g. Research Hubs
Professional Education and Development Role
- Participate fully in the Appraisal and Development Review Process.
- Complete the Competency Framework for the role and achieve the minimum skill set (list of competencies as defined in generic competency framework).
- Maintaining own learning record of evidence.
- Complete the Trust Care Certificate within the assigned 3-month period, and any other training relevant to the post e.g. Good Clinical Practice and Informed Consent training
Develop a sound knowledge of clinical research and support and contribute to the orientation of new/temporary staff.
- Initiate, develop and strengthen interpersonal relationships with all members of the multidisciplinary team ensuring good team working, collaborative working practices and professionalism throughout the department.
- Deal with interpersonal conflict and escalate to senior nurse to assist with resolution of any adverse situation/incidents.
- Comply and promote compliance to Trust policies e.g. Harassment and Bullying.
Job description
Job responsibilities
Research, Patient Experience and Use of Resources
- To contribute to the co-ordination of Clinical Trial activities within the relevant departments.
- To assist with reviewing new Trial protocols and contribute to the assessment of their clinical and practical implications (including feasibility and risk) to local patients and the relevant departments.
- Receive consent from research participants into low-risk research trials with oversight from your line manager and senior colleagues.
- To provide clinical and admin support for a number of clinical trial protocols
- Assist in the identification, screening, and assessment of the suitability of local patients to take part in Clinical Trials, in accordance with specified inclusion/exclusion criteria.
- To provide information to patients about participating in clinical trials, including the risks and benefits of participation and to facilitate the process of gaining their informed consent under the supervision of Research Nurses and Principal Investigators.
- With appropriate training and oversight, undertake trial specific sampling as required by the protocol, to support the team to establish the eligibility of patients and to ensure their safe entry into and participation in clinical trials.
- To act as a contact for clinical trial patients within the relevant department and to be a resource for these patients and their families with respect to trial activities.
- Promoting research at ward level, encouraging staff to support research in order to aid recruitment.
- To maintain accurate documentation in an auditable format and accurately record data as required by each trial, including transcribing, and exporting data from medical records and hospital IT systems to clinical trial case report forms (CRFs) as required by trial protocols.
- To ensure the timely submission of accurate and completed CRFs to the trial co-ordinating centre and providing expedited responses to data queries and nonsensical information.
- To use trial internet-based databases and software to organise, report, record and monitor trial activities, including updating details of patients screened and recruited into clinical trials.
- To schedule clinic appointments for trial follow-up visits and refer patients for the relevant investigations as determined by the relevant trial protocol.
- Contribute to the person-centred care of patients in clinical trials; initiating investigations where appropriate and referring to Research Nurses or the Principal Investigator where necessary.
- Provide general administrative support to clinical trials, including filing, typing, fielding telephone calls, ordering patient notes and retrieving patient test results via hospital IT systems.
- Make arrangements for pathological samples, radiological films and electronic data to be sent for central review.
- Support the clinical research teams in preparing trial documentation for monitoring visits from trial sponsors and regulatory agencies.
- To work to Standard Operating Procedures for clinical trials set by the Trust and trial co-ordinators.
- To ensure all activities undertaken meet the standards set out by the Principles of Good Clinical Practice and National Research Governance Framework for Health and Social Care and adhere to all applicable regulatory requirements.
- May be required to work unsocial hours as necessary dependent on the needs of the service.
- May be required to work across more than one location e.g. Research Hubs
Professional Education and Development Role
- Participate fully in the Appraisal and Development Review Process.
- Complete the Competency Framework for the role and achieve the minimum skill set (list of competencies as defined in generic competency framework).
- Maintaining own learning record of evidence.
- Complete the Trust Care Certificate within the assigned 3-month period, and any other training relevant to the post e.g. Good Clinical Practice and Informed Consent training
Develop a sound knowledge of clinical research and support and contribute to the orientation of new/temporary staff.
- Initiate, develop and strengthen interpersonal relationships with all members of the multidisciplinary team ensuring good team working, collaborative working practices and professionalism throughout the department.
- Deal with interpersonal conflict and escalate to senior nurse to assist with resolution of any adverse situation/incidents.
- Comply and promote compliance to Trust policies e.g. Harassment and Bullying.
Person Specification
Qualifications
Essential
- NVQ 3 in Health and Social Care or equivalent relevant experience
- Completed Care Certificate or ability to complete within 3-months of appointment
- English and Maths qualification GCSE/Functional skills at level 1 or equivalent
Desirable
- Good Clinical Practice (GCP) training for research
Experience
Essential
- Can demonstrate understanding of and share the Trust values of Working Together for Patients with Compassion as One Team Always Improving
- Desire to deliver compassion hands-on-care in the hospital environment as per study protocol
Desirable
- Previous experience of clinical trials or research projects
- Experienced in phlebotomy and vital signs observations
Skills and Knowledge
Essential
- Effective interpersonal skills
- Excellent verbal and written communication skills
- Ability to gather data, compile information and prepare reports to present to key stakeholders
- Skill in organising resources and establishing priorities including time management
- Ability to maintain record keeping systems and procedures
- Ability to operate a PC with knowledge of word processing, including spreadsheets, database, and presentation software.
- Strong customer service skills
Desirable
- Ability to understand and work with financial, administrative and personnel processes and practises.
Person Specification
Qualifications
Essential
- NVQ 3 in Health and Social Care or equivalent relevant experience
- Completed Care Certificate or ability to complete within 3-months of appointment
- English and Maths qualification GCSE/Functional skills at level 1 or equivalent
Desirable
- Good Clinical Practice (GCP) training for research
Experience
Essential
- Can demonstrate understanding of and share the Trust values of Working Together for Patients with Compassion as One Team Always Improving
- Desire to deliver compassion hands-on-care in the hospital environment as per study protocol
Desirable
- Previous experience of clinical trials or research projects
- Experienced in phlebotomy and vital signs observations
Skills and Knowledge
Essential
- Effective interpersonal skills
- Excellent verbal and written communication skills
- Ability to gather data, compile information and prepare reports to present to key stakeholders
- Skill in organising resources and establishing priorities including time management
- Ability to maintain record keeping systems and procedures
- Ability to operate a PC with knowledge of word processing, including spreadsheets, database, and presentation software.
- Strong customer service skills
Desirable
- Ability to understand and work with financial, administrative and personnel processes and practises.
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.
