Overview
The post holder will be responsible for co-ordinating an agreed portfolio of non-commercial and commercial clinical trials.
The Trust provides a full range of local and specialist services across its five sites. The strategy of Strong Roots, Global Reach reflects our Vision to be Bold, Brilliant in people, Outstanding care, Leaders in Research, Innovation and Education, Diversity, Equality and Inclusion at the heart of everything we do. By being person-centred, digitally-enabled, and focused on sustainability, we aim to take King’s College Hospital NHS Foundation Trust to another level.
Job Responsibilities
Clinical Responsibilities
- Work with the Senior Research Nurse/Clinical Trials Coordinator to manage a caseload of patients as part of a multidisciplinary team.
- Maintain effective communication with patients, carers and professionals to ensure service delivery. Screen patients suitable for entry into clinical trials (attending clinics and Multidisciplinary Team meetings).
- Identify patients suitable for entry into clinical trials via clinics (screening notes/consultant referrals) and MDT meetings.
- Ensure patients are fully informed prior to entry into any clinical trial programme.
- Assist in consenting, randomising and allocating treatment of patients.
- Evaluate patient eligibility, co-ordinate pre-study tests, obtain results and arrange appointments according to trial protocol.
- Provide support to patients and relatives, explaining practical aspects of clinical trials and supporting local nursing teams.
- Act as key worker for patients on trial, liaising with clinical nurse specialists to ensure appropriate care.
- Coordinate collection of blood samples and ensure safe storage of specimens in liaison with local nursing teams; ensure safe packaging and transport of biological specimens per IATA.
- Support administration of trial drugs (as trained), report any unusual side effects with local nursing teams.
- Maintain patient records and ensure accurate documentation in medical and nursing notes; complete Case Report Forms (CRFs) accurately.
- Collect, co-ordinate and computerise data generated from the clinical trials; provide continuity of care for patients and carers.
- Ensure community care teams are aware of patient progress for fully coordinated care.
- Adhere to Good Clinical Practice (GCP) as set out in Clinical Trials Regulations; train in cannulation, phlebotomy and care of Central Venous Access lines if appropriately trained.
- Act as a resource for liver-based research.
Portfolio Management and Development
- Review trial protocols and identify resource implications for the site.
- Set up and maintain the Trial Master File/Site File with essential documents; organise initiation meetings.
- Coordinate on-study treatment and follow up with medical teams/sponsor organizations; ensure CRFs are completed accurately and timely.
- Record SAEs per protocol and sponsor SOPs; for network trials, upload accrual data to the NIHR CRN portal using the EDGE database and assist with invoicing where appropriate.
- Promote integration of research within the site and maintain open communication with departments and wards; inform appropriate personnel about the portfolio of trials.
- Present research findings within the Clinical Research Network South London and externally as appropriate; report adverse incidents and near misses via the Trust’s incident reporting system.
- Coordinate multi-centre trials (where appropriate) with KHP CTO; ensure documents and approvals are in place prior to recruitment and keep sites updated on protocol changes.
- Collect data from sites and resolve data queries.
Training and Development
- Attend KHP CTO, NIHR CRN and CRN South London training programmes and other relevant education days; participate in investigator/initiation meetings when required.
- Maintain awareness of advances in hepatology treatments, research and nursing practice; disseminate research by assisting in preparing posters/research papers and presenting locally.
Professional
- Act in accordance with local policies and procedures; maintain a professional profile.
- Work within the NMC Scope of Professional Practice, Conduct and Record Keeping; undertake an annual appraisal to identify objectives and development needs.
General
- Duty of care for own health and safety and that of colleagues, patients and visitors; observe rules, policies and standards of King’s College Hospital NHS Trust and statutory/professional obligations.
- Live and role model the King’s Values: Understanding you, Inspiring confidence in our care, Working together, Always aiming higher, Making a difference in our community.
- Maintain confidentiality of patient and staff information; contribute to personal and professional development.
- This job description is a guide to the general scope of duties and may be reviewed in consultation with the post holder.
- All employees must hold an NHS.net email account for Trust communications.
Safeguarding
The Trust takes safeguarding seriously. All employees should attend mandatory safeguarding training and familiarise themselves with reporting processes.
Infection Control
Post holder has responsibility for infection control; be familiar with infection control and hygiene procedures and policies, as described in the National Code of Practice on Infection Control and local policies, to be followed at all times.
Qualifications and Experience
Essential
Education and qualifications: Nursing Degree Adult RN; evidence of continuous personal, professional and academic development.
Desirable
Post-registration qualification, postgraduate research methodology, and a GCP qualification.
Knowledge and Experience
Essential
Previous clinical research experience; previous post-registration/post-graduate experience within the Liver department.
Desirable
Previous liver nursing experience; experience collaborating with other agencies; knowledge of handling complex relationships.
Skills and Competencies
Essential
- Understanding of regulatory requirements pertaining to trials
- Excellent communication and interpersonal skills
- Ability to perform basic clinical skills (vital signs, venepuncture, cannulation)
- Attention to data accuracy and detail
- Organisational and coordination abilities; ability to work within a team
- Strong motivation to work in Liver research; flexible hours
Desirable
- Report writing and presentation skills; cross-boundary collaboration; line management experience
- IT skills across MS Office and data analysis tasks
Additional Information
Disclosure and Barring Service (DBS) checks, Skilled Worker sponsorship, UK registration requirements, and employer details are part of the application process as described in the original advert.