The post holder will be responsible for the day to day management of several of the R&D clinical research studies and teams......
The post holder will be responsible for the day to day management of several of the R&D clinical research studies and teams. The post holder will be supporting the safe conduct of research in accordance with the regulatory and legal frameworks relating to the planning, undertaking and closure of research studies providing assurance that the rights and well being of trial participants are protected.
Excellent support from the close-knit management team will be provided including a comprehensive induction package and the opportunity to really develop as a manager and leader of a patient focused, quality driven, cutting-edge service.
The post holder will be instrumental in implementing team objectives to enhance the performance and development of the research teams whilst providing guidance, education, leadership and co-ordinating the portfolio of research studies and clinical trials to deliver high quality research and clinical care.
The role integrates both clinical duties such as maintaining an active caseload and managerial duties; as such the post holder will be required to effectively manage their time to fulfil key responsibilities. It is also expected that the post holder will be flexible with hours of work as required to ensure that we are offering a service that best suits the needs of our patients.
The post holder will be employed by Research and Development department (R&D) to work within the central clinical research teams of Accident and Emergency, Critical care and Trauma and Orthopaedics, managing an allocated number of research teams.
However, it is expected that the post folder will work flexibly across other research speciality areas as service requirements dictate throughout the duration of their contract.
The post holder will be responsible for the day to day management of several of the R&D clinical research studies and teams. The post holder will be supporting the safe conduct of research in accordance with the regulatory and legal frameworks relating to the planning, undertaking and closure of research studies providing assurance that the rights and well being of trial participants are protected.
The job holder may be required to carry out other similar or related duties within their bounds of registration which do not fall within the work outlined which may reasonably be required to deliver a comprehensive research service to our patients. The Line Manager, in consultation with the post holder will undertake any review.
Closing Date: Please be advised that this job advert will close as soon as sufficient applications have been received. Please apply for this job as soon as you can, if interested.
University Hospitals Coventry and Warwickshire NHS Trust, rated as good by the Care Quality Commission, is one of the largest teaching Trusts in the UK.
We are extremely proud of our employees across our hospital sites, with high quality patient care at the heart of everything we do.
Boasting some of the most modern facilities in Western Europe, the Trust is renowned for being at the forefront of research and innovation as part of its blossoming reputation as a worldwide leader in healthcare.
We are proud to be recognised as a Pathway to Excellence®designated organisation – please click the link for further details about this prestigious award.Pathway To Excellence ® - University Hospitals Coventry & Warwickshire (uhcw.nhs.uk)
By joining our exciting journey, you will form part of a passionate, talented team and will be able to access a wide range of learning and development opportunities. There has never been a better time to join our team.
The Trust is committed to building an organisation that makes full use of the talents, skills, experience, and different perspectives available in our diverse society. We want everyone to feel they are respected, valued, can achieve their potential and receive the most appropriate and relevant care. We will create an environment where the equality and human rights principles of fairness, respect, equality, dignity and autonomy are promoted and are part of the organisation's core values.
Clinical
• Work autonomously to manage a caseload of patients acting as a professional to ensure care to patients is delivered according to Trust policies and procedures and the research protocol delivery high standards and continuity of clinical care for study participants.
• Maintain strong relationships and communication channels with other key personnel such as multidisciplinary teams, clinical wards areas.
• Attend Multi-disciplinary Meetings, and appropriate clinics, to assess volunteers/patients for eligibility for research and recruit new patients, to act as a resource to the members of the MDT.
• Ensure that trial specific clinical investigations / procedures are undertaken as required by the research protocol in order to establish eligibility and maintain safety in the trial by all team members.
• Take relevant samples as required by the study protocol such as blood samples, package and dispatch as defined. Ensure safe and appropriate storage of specimens in accordance with trial protocols and regulatory / Trust guidance.
• Ensure all team members undertake relevant training and assessment of competence, working within scope of professional practice prior to undertaking any clinical procedures / administration of treatments associated with the research treatment regimes.
• Ensure the safe administration of treatments and drugs that are given within the context of a clinical trial by all team members.
• Ensure staff monitor treatment toxicity/side effects reporting to the relevant personnel, recording as required assisting in any required changes to treatment as required by the protocol
• Ensure all staff record and report adverse /serious adverse events as classified in the study protocol criteria which occur whilst patient is in the clinical trial e.g. hospital admission since last study visit
• Ensure accurate documentation of patient’s events in nursing/medical notes and study specific case report forms.
• Provide ongoing information, education and support to patients (and their significant others) regarding clinical trials and their care.
Research and Portfolio Management
• Lead in the delivery of studies within the relevant specialities ensuring they meet the requirements with regards to the Department of Health’s Research Governance Framework for Health and Social Care and the EU Clinical Trials legislation by implementing quality systems.
• Assist in the review of study protocols and contribute to the feasibility/study selection process, advising on safety, regulatory and logistical issues.
• Liaise with RD&I Set Up Team staff contributing to the process of gaining local regulatory committee approval where required to ensure efficient service is delivered to sponsors.
• Work with the research teams and investigators to develop strategies to overcome barriers to recruitment and solve other problems relating to specific studies.
• Following appropriate training and competence assessment receive written informed consent from participants for allocated research studies in accordance with study protocol and Trust guidance.
• Following appropriate training and competence assessment act as an assessor for the process of informed consent for research according to Trust guidelines.
• Randomise / enrol patients into clinical trials or other research studies.
• Assess and evaluate the progress of on-going clinical trials and research identifying resource implications for the teams.
• Co-ordinate the monthly local portfolio team performance meetings: identify and act on issues.
• Ensure accurate records for all research projects that are overseen within allocated teams are kept in accordance with all regulatory requirements including the data protection act
• Ensure that all ICH GCP required documentation is kept in a clearly traceable system and is stored in an appropriate manner for the appropriate length of time.
• Provide advice and support to other members of the research and multidisciplinary team with regard to research governance.
• Ensure self and team members respond to data queries generated by the study co-ordinating team within a timely manner.
• Ensure all team members maintain accurate records of study recruitment as per local procedure and status of studies providing regular updates. This will involve ensuring that EDGE (local patient management system) is updated with key trial data and feeding back through the local portfolio team meetings
For further details please see the attached job description.
This advert closes on Monday 27 May 2024
