Agile Surgery & Surgical Oncology Clinical Research Nurse

The post holder will support and co-ordinate the GCP compliant setup, delivery and close down of a portfolio of research studies across the Surgery and Surgical Oncology directorates, ensuring teams are supported to setup and deliver studies in a timely manner by providing appropriate governance oversight of the portfolio. They will work across the Surgery and Surgical Oncology Directorates to support teams to ensure the successful working of the clinical research projects they are assigned to. Where needed, they will supervise and mentor other staff, acting as line manager, whilst actively contributing to evaluation and improvement of the service. In conjunction with the other members of the team, they will facilitate the production of good quality research.

Main duties of the job

• Following supporting the setup of studies, the research nurse will facilitate and aid recruitment of patients.
• The role will include identifying, consenting and following up suitable patients for clinical research working autonomously within professional practice guidelines and within the Research Governance Framework.
• The post holder will take responsibility for the safe administration of experimental therapies, and for monitoring the expected and unexpected side effects of drugs and other treatment modalities used in these trials.
• The post holder will manage a caseload of participants across Surgery and Surgical Oncology.
• They will have a duty of care in supporting them and their families throughout their participation in any research activity.
• They will also act as a patient advocate providing support and oversight as required.
• In addition, the research nurse will co-ordinate the portfolio of clinical research studies supporting and have oversight of the study set up, delivery (including data collection and site file maintenance), study close down and archiving.
• The post holder will play a key role in ensuring that any research is undertaken within the department safeguards the wellbeing of the patients and is conducted according to Good Clinical Practice (GCP) and the Medicines for Human Use (Clinical Trial) Regulations 2004 and Amended Regulations 2006.

Working for our organisation

This role will work with teams across Surgery and Surgical Oncology. Surgery Directorate comprises Trauma, Orthopaedics and Plastics. The Surgical Oncology Directorate comprises breast, head and neck, thoracic surgery, ear, nose and throat, audiology, and gynae-oncology. The teams deliver a mix of Commercial and Non Commercial research ranging from CTIMPs, device trials and observation and data only studies.

Detailed job description and main responsibilities

Clinical and Communication Responsibilities

• Manage a caseload of participants acting as a professional in ensuring a duty of care to the participant and their families.
• Work within relevant regulations and ICH GCP, Trust’s policies, research governance, Medicines for Human Use Regulations, DPA and HTA ensuring protocol adherence.
• Devise, implement and evaluate strategies for identifying participants, including attending clinics, screening notes and MDT meetings.
• Participate in the informed consent process.
• For appropriate studies take informed consent and ensure on-going consent in accordance with the necessary Trust research governance arrangements and necessary competent regulatory authority Regulations and International Conference on Harmonisation of Good Clinical Practice (ICH GCP).
• Co-ordinate the research participant pathway.
• Set up, collect and maintain adequate trial data and documentation via completion of participant records/case reports forms and investigator site files, ensuring the necessary information is documented in the electronic medical notes and databases, and communicated with clinical teams.
• Report any adverse events or health concerns which occur whilst the participant to the appropriate doctor, investigator or nurse in a timely manner.
• Undertake a range of clinical tasks in line with personal competencies as per protocol e.g. blood pressure, temperature, respirations, questionnaires, urinalysis, weight and height.
• Perform tasks requiring clinical and laboratory skills, including drug administration and clinical observation, phlebotomy, venepuncture, biological sample preparation within clinical area and laboratories.
• Have responsibility for the correct administration and custody of medicines according to Trust policy.
• Responsible for safe tracking, storage, efficient transport and robust documentation of participants samples.
• Liaise with the clinical team to organise and ensure that study specific investigations are undertaken according to the protocol, obtain and document the results.
• Report any side effects or adverse events according to protocol guidelines and within the required timeframe.
• Deal with concerns raised by participants and visitors in a proactive manner and take remedial action as necessary.
• Report to the senior clinical research staff any clinical incidences.
• Assist in managing incidents, accidents and complaints in accordance with Trust Policies.
• Manage clinical incidents.
• Carry out protocol activities without direct supervision.
• Recruit, and follow up, patients.
• Act as a patient advocate.
• Ensure there is sufficient skill mix of staff for patient safety during clinical trials and ensuring that they are carried out within the Trust and Centre's policies and clinical trial protocol.
• Assist and advise staff, both registered and unregistered in the delivery of care to the volunteer.
• Report any deviation from normal practice or clinical trial protocols to senior staff and contribute to and implement agreed corrective and preventative actions.
• Deal with concerns raised in a proactive manner and take remedial action as necessary.

Administration

• Assist and co-ordinate in the process of gaining local regulatory approvals.
• Assist in the review of research study protocols and identify resource implications for the site.
• Liaise with study set-up teams to facilitate smooth and effective study set-up.
• Assist in completing submissions.
• Process amendments and disseminate information to relevant departments.
• Participate in the collation of data, including performance data.
• Responsible for accurate and timely completion of Clinical Report Forms (CRFs) and for ensuring that all data queries are dealt with in a timely and efficient manner.
• Ensure timely information and reports to reflect recruitment of patients including timely entry to EDGE according to team processes.
• Actively work to achieve study accrual targets including engaging with the research team and clinical teams to overcome barriers to participant enrolment.
• Monitor patient recruitment and data collection.
• Organise and facilitate Sponsor meetings and visits.
• Support archiving.
• Build strong professional relationships.
• Educate appropriate medical and nursing personnel and departments.
• Maintain a dialogue of progress with the team.
• Participate in the presentation of research findings.
• Provide cover when necessary.
• Plan, organise and deploy staff according to ability and workload in order to meet volunteer needs.
• Ensure that nursing practices comply with Trust policies and procedures.
• Maintain a safe working environment.
• Assist in managing and reporting of incidents.
• Ensure equipment is in good working order, and report appropriately when defective.
• Participate in audits.
• Ensure the economical use of resources.
• Contribute to the overall control of the ward or departmental budget and identify areas where cost improvements can be made.
• Actively participate in and support the development of the clinical research.
• Promote and participate in the implementation of policies within the Directorates and to ensure compliance with necessary Trust, Government and EU Directives.
• Set up and maintain accurate documentation in clinical trial documents and databases, case report forms, investigator site files, trial master files and patient notes.
• Ensure that clinical trials are effectively archived and then destroyed once approved as required.

Management and Leadership

• Provide specialist advice and training to colleagues as relevant to your role.
• Supervise, train or mentor new or more junior staff as required.
• Line manage appropriate members of the team, oversee their development needs and ensure annual performance development reviews are completed if required.
• Ensure implementation of policies and highlight changes where needed.
• Proactively make recommendations to improve the quality of service delivery.
• Report incidents in line with Trust processes and support team leaders in investigating and resolving issues.
• Act up for senior research nurse as required.
• Act as a role model for excellence in research delivery.
• Take active role in department training programme.
• Assist with the preparation of posters/research papers for meetings, conferences or publications.
• Represent the research team at local, national and international forums.
• Participate and attend investigator meetings and conferences when required.

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.
• Contribute to updating, developing and implementing Standard Operating Procedures (SOPs).
• Undertake an Individual Performance Review annually with your Line Manager.
• Maintain a record to reflect any training carried out pertaining to the post and ensure direct reports maintain training files.
• Assist in the education and support of health care professionals to enable them to care for clinical trial patients and recruit to clinical trials where appropriate.
• Maintain an up to date knowledge of research related topics particularly related to clinical trials.
• Attend local and national meetings as appropriate and as agreed with the local co-ordinating centre.
• Attend regular update sessions at GSTT including the Clinical Research Nurse and Midwife Forum.
• Assist the team in orientating all new staff and students to the ward or department.
• Provide teaching and development to the nursing team and students helping them to achieve their learning outcomes.
• Act as a role model, mentor and preceptor to the nursing team.

Other

• 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 through the adherence of research policies and clinical trials budgets.
• Actively seek to develop the role to take account of changing requirements of the service.
• Implement and adhere to relevant regulatory requirements related to study conduct.
• Work collaboratively with colleagues across R&D and wider GSTT to facilitate the achievement of objectives and shared learning.
• Understand and adhere to Trust policies and procedures.
• To maintain patient confidentiality and standards of Good Clinical Practice (GCP) at all times.

Person specification

Knowledge/Qualifications

• Level 1 Registered Nurse NMC (Adult or RSCN) Registration with previous acute NHS experience.
• Educated to degree level or above.
• Relevant specialist course or equivalent experience.
• Evidence of continuing professional development.
• GCP certificate.
• Knowledge of NMC Code of Professional Conduct.
• A Clinical Research qualification.
• ILS certificate.

Experience

• Extensive experience of working within the NHS as a qualified nurse.
• Experience in coordinating the setup and delivery of Clinical Research in NHS.
• Experience with accessing and managing research data, databases, and Excel Spreadsheets.
• Experience of effective multidisciplinary team working.
• Experience teaching, assessing, supervising others in clinical setting.
• Experienced and competent in the management of patients within the speciality.

Skills

• Excellent written and oral communication skills with ability to deal with complex and sensitive situations.
• Knowledge of research methodologies.
• Able to acquire in-depth knowledge to organise, co-ordinate and deliver research protocols and communicate this to multi-disciplinary team and participants.
• Ability to interpret patient records and extract data accurately.
• Competency in Venepuncture, cannulation, medication administration including IV drugs and IV infusions.
• Awareness of clinical governance and risk management relevant to the role.
• Ability to work autonomously in a small team, as well as acting as a team player in the wider multidisciplinary team.
• Ability to lead, teach, supervise and mentor others in all aspects of clinical research delivery.
• IT skills including use of email and office packages.
• Flexible approach towards teamwork and patient/family involvement.
• Enthusiastic, motivated, professional and accountable.
• Knowledge of quality, standard setting, benchmarking and audit.
• Ability to perform clinical activities specific to speciality.
• Proficient with basic laboratory skills and able to mentor others.

Guy’s and St Thomas’ celebrates, respects and values the diversity of its staff and patients. We review our policies, procedures and practices to ensure that all employees, patients and carers are treated equitably according to their needs. We are actively committed to ensuring that no one who applies for a job, works or studies at the Trust, or accesses our services is discriminated against on the grounds of race, ethnicity, nationality, disability, religion or belief, age, gender identity, gender reassignment, sexual orientation, pregnancy and maternity/paternity, or marital/civil partnership. Applications are welcomed from applicants with a disability. We can make reasonable adjustments and offer support and advice in a variety of ways throughout the application process. Equality of opportunity is our policy. As an organisation we are committed to developing our services in ways that best suit the needs of our patients. This means that some staff groups will increasingly be asked to work a more flexible shift pattern so that we can offer services in the evenings or at weekends. We are committed to supporting all employees to achieve a healthy work life balance and to work in a way that is best for them and our patients. We will consider all requests to work flexibly, taking into account the individual’s personal circumstances as well the needs of the service. We encourage all prospective applicants to discuss their individual circumstances with the recruiting manager as part of the on-boarding process.