Job responsibilities
For the full Person Specification and more informationregardingthe main responsibilities of this role, please refer to the attached Job Description.
The Team leader will work autonomously to support the running of clinical trials and observational studies across an identified area.
The role will entail clinical and management/leadership responsibilities, the ratio will be determined by the needs of the service and will fluctuate as the portfolio evolves.
To provide line management to staff members in the research delivery workforce, including, but not limited to, Research Nurses, Clinical Trial Practitioners and Research Coordinators.
To recruit patients into clinical trials as per Good Clinical Practice (GCP)
To design and deliver training to all members of the team as required
To lead of projects as directed Rheumatology Clinical Research Lead
Maintain health, safety and security of self and others in own work area through ensuring own and others knowledge of relevant local / national policies and procedures, and that these are adhered to
Work according to the Good Clinical Practice and relevant professional standards and guidelines
Promote peoples equity, diversity and rights, through ensuring that own and others practice is in the best interests of patients
Develop own knowledge and expertise within the speciality / research field
Refer to other health professionals when this will improve health outcomes or when risks and needs are beyond own competence and scope of practice
Support patients in the delivery of care and meeting their health and wellbeing needs by providing advice and information, promoting their wishes and beliefs and addressing their concerns
Monitor and review the effectiveness of interventions with the patient and colleagues and modify this to meet changing needs and established goals
Facilitate recruitment of patients into studies.
Management of Investigator Site Files and relevant trial documentation.
Completion of relevant patient-related study documentation and maintenance of study related electronic records.
Ensuring contractual local and national regulatory authority obligations are observed.
Provide administrative support related to the interventional and cohort studies
Report recruitment metrics as required and resolve data queries
Cross support the Centre support team for key activities and events, including Centre meetings, PPIE events, International scientific panel (ISP) visits, Symposium, and funder inspections and visits
The successful candidate will be strongly encouraged to develop phlebotomy skills.
EDUCATION AND RESEARCH
Assist with or lead (as appropriate) the assessment, development, implementation and evaluation of clinical research studies, and the setting of standards of practice
Assist with or lead (as appropriate) patient recruitment and day to day management / organisation of clinical trials and studies, to include: patient assessment, data collection and database management, blood sample collection and sample processing, monitoring of adverse reactions and compliance
Assist with data entry on to clinical trial data bases
Have an up to date working knowledge of governing research legislation
Ensure the specific study protocols and procedures are adhered to in accordance with local practice and Good Clinical Practice Guidelines (GCP)
Participate in audit programmes and identify areas of potential research relating to the speciality
Identify own developmental needs and establish objectives for personal development
Take part in reflection and appropriate learning from practice, in order to maintain and develop competence and performance
QUALITY ASSURANCE
Assist with external audit and regulatory inspection of studies, as well as routine internal audits of processes
Contribute to the creation and maintenance of Standard Operating Procedures
Ensure strict adherence to research protocols, including specific requirements for blood sample collection and processing, all trial assessments, adverse event recording, and accurate and legible documentation including all source data and medical record scripts.
To ensure that the correct version of the trial protocol and all other study documents are used at all times.
Direct and support nurses on the application of and adherence to QA processes, in order to maintain regulatory compliance across all clinical research services.
CONSULTANCY/COLLABORATION
Provide advice and support to the multi disciplinary team both internally and externally regarding patients and research studies
Contribute to effective communication between trial centres, sponsors and investigator sites nationally and internationally as required
Promote effective communication with study participants regarding study protocol, patient information sheets and consenting procedures and abide by ICH/GCP research practice
Ensure that appropriate information is disseminated within the speciality, the organisation and within external agencies and forums
Disseminate study data, research outcomes and specialist knowledge via poster presentations, written publication and other media as appropriate at local, national and international conferences
LEADERSHIP / MANAGEMENT
Develop effective planning, organising, problem-solving and prioritisation skills
Manage own workload effectively through developing project and time management skills
Responsible for the management of a caseload, including liaison, where appropriate, with other agencies and the provision of specialist advice within this clinical area
Assist with training junior staff members
Negotiate and agree with individuals, groups and other practitioners, outcomes, roles and responsibilities and action to be taken to develop resources, services and facilities
Maintain appropriate channels and styles of communication to meet the needs of patients, relatives and carers, managers, peers and other professions / agencies.
Develop and use effective decision-making skills and evaluate the process and results
Liaise with sponsor companies, Research & Development Department (R&D) and Local Research Ethics Committee (LREC) where appropriate
Responsible and accountable for resource issues directly related to the research studies as delegated
Liaise with Divisional and related departments (i.e. pharmacy and laboratories) as appropriate
Ensure adequate study supplies are maintained; order further stocks/supplies as required
Contribute to local, national and international research nurse/Clinical Trials Practitioner networks to exchange and enhance knowledge and expertise
Participate in a peer network of support, information and learning with other research nurses/Clinical Trials Practitioner at UCLH
GENERAL
Adhere to the UCLH Service Commitment "Putting Patients First" and adopt a professional approach to customer care at all times.
Comply with the Trusts Equal Opportunities Policy and treat staff, patients, colleagues and potential employees with dignity and respect at all times.
Take personal responsibility for promoting a safe environment and safe patient care by identifying areas of risk and following the Incident, Serious Incidents and Near Misses reporting policy and procedure.
Take personal responsibility for ensuring that UCLH resources are used efficiently and with minimum wastage, and to comply with the Trust's Standing Financial Instructions (SFIs).
Comply with Trust policies for personal and patient safety and for prevention of healthcare-associated infection (HCAI); this includes a requirement for rigorous and consistent compliance with Trust policies for hand hygiene, use of personal protective equipment and safe disposal of sharps.
In accordance with the Trust's responsibilities under the Civil Contingencies Act 2004 to undertake work and alternative duties as reasonably directed at variable locations in the event of and for the duration of a significant internal incident, major incident or pandemic.
Be aware of and adhere to all Trust policies and procedures, the Health and Safety at Work Act and the Data Protection Act.
Maintain confidentiality at all times
OTHER
These guidelines are provided to assist in the performance of the contract but are not a condition of the contract. The job description is not intended to be exhaustive and it is likely that duties may be altered from time to time in the light of changing circumstances and after consultation with the post holder.
All staff will be regularly assessed on their knowledge, skills and behaviour, and application of all aspects of the job description, in line with the Trusts Personal Development Review (PDR) process.
Staff will also be expected to abide by the relevant code of professional practice relating to their discipline.
Come and be a part of the best NHS trust in England to work for, according to our staff*
*UCLH top trust to work at in England- In the most recentNHS staff surveyUCLH had the highest percentage of staff who said they would recommend us as a place to work, out of all general acute or acute/community NHS trusts in England for the third year in a row.
UCLH recognises the benefits of flexible working for staff To find out more, visit:Flexible working.
To discover more about what makes UCLHa great placeto work, visit:Why Choose UCLH?
