PRINCIPAL DUTIES & AREAS OF RESPONSIBILITY Leadership As the lead specialist within your defined area of research you will pr.....
PRINCIPAL DUTIES & AREAS OF RESPONSIBILITY Leadership As the lead specialist within your defined area of research you will provide leadership and management to the clinical research team, including team and individual performance, attendance, management and workforce planning Be accountable for own actions, acting as a role model to promote the research agenda Support and inspire staff to provide efficient, effective, safe quality care to patients participating in research trials, ensuring a positive patient experience Promote the building of effective teams and collaboration between teams Anticipate problems and take preventative actions or have contingency plans available Work with the Lead Nurse/Matron/Head of Nursing/AHP and lead Clinician to develop the team reflecting the CSU and Trust research strategy, developing new roles and ways of working Delegate and empower staff whilst maintaining overall, continuing responsibility and accountability Ensure that the effective deployment (working across teams and CSUs) where necessary and appropriate) of staff is mapped against the projected recruitment to trial portfolio to ensure safe and effective cover Deliver an effective, safe, quality research service within budgetary envelope reporting, investigating and responding to accidents, complaints, untoward incidents and other significant events Raise and respond to concerns with regards to risk, danger, malpractice or wrongdoing by following the LTHT whistleblowing policy and supporting process Clinical Research Review and lead the implementation of Clinical Research undertaken within the department. Maintain an accurate record to assess and evaluate the progress of on-going clinical trials and research undertaken in the department and regularly update the department/CSU on the status of the projects To accurately record data on trial pro-forma, co-ordinate monitoring visits from sponsoring companies and respond promptly to data queries. To safeguard interest of patients by liaison with relevant trial personnel and contribution to trial design and protocol and ensure compliance with research guidelines. To ensure that all proposed research projects carried out in the department are registered and reviewed by the Trust R&I department, have all regulatory permissions/approvals prior to commencement and that updates/amendments are reported in a timely fashion. To ensure recruitment to trials is in line with the Department of Health (DoH) and NIHR timelines and high level objective matrix To maintain patient safety by accurately and promptly reporting and documenting (Serious) Adverse Events, Reactions or incidents, to the relevant clinical, sponsor and authorities within required timelines. Ensuring any potential drug interactions, any interventions or modifications are carried out and information disseminated to staff in all relevant areas. To drive and encourage the participation in original research carried out in the CSU. To provide advice and support to other members of the multidisciplinary team with regard to research guidelines, REC registration and approval, project development, implementation, completion and dissemination. Liaison with the multidisciplinary team to promote and oversee the appropriate referral and recruitment of patients to research within the department/unit for which the post holder has a designated responsibility. Ensure clear, accurate records are maintained. Developing data collection, case report forms, and design of database where required, with a clearly trackable system/audit trail and is stored for the appropriate time. To establish and maintain good working relationships and channels of communication with all support services, other departments within the Trust, other relevant hospitals and Trusts, non-commercial bodies and industry sponsors regarding feasibility and implementation aspects of proposed clinical trials. Monitor and plan in advance workload of the department ensuring it is adequately resourced. Ensure study close down, study dissemination and archiving is implemented in line with requirements of the NHS, sponsor, GCP and MHRA. Clinical Service and Professional Responsibilities To work as part of the multidisciplinary team and contribute to the on-going development of the department and CSU research strategy. Develop protocols for research practice and ensure these are reviewed and updated on a regular basis. Also to review other relevant departmental and Trust protocols to ensure they are applied appropriately. To provide on-going advice and information to patients/volunteers with regard to their participation in clinical research in order to facilitate effective informed consent. To assist the clinicians in the assessment of patients/volunteers for eligibility for research and monitoring of their condition throughout their participation. Education and training of various groups, being responsible for ensuring that your direct managed staff receive and engage with the relevant, appropriate clinical skills training and maintain related clinical competencies To perform venepuncture and cannulation when required for research purposes, processing biological samples as per trial protocols. To educate patients with regards to trial medications particularly when medications require home self-administration. To administer trial medications according to trial protocols. To be responsible for maintaining strong relationships and positive communication channels with other key personnel. To be responsible for developing and sustaining own knowledge, clinical skills and professional awareness. To co-ordinate educational meetings for both research and non-research staff. To undertake national advisory and monitoring roles where appropriate. To drive and encourage the participation in original research carried out in the department for self and junior members of the team. To observe the confidentiality of patient information at all times, both in accordance with the Data Protection Act. To be conversant with cardiac arrest, major incident and fire procedures as they relate to clinics within the Directorate. Undertake duties on other wards or departments as and when required by service demands or patient need Personal Education, Training and Development To keep up to date with departmental, Trust, NHS and EU developments for the management of clinical research ensuring timely, effective implementation of changes. To keep up to date with current and potential research and information relevant to the care of patients in the clinical area. To attend courses as deemed relevant and to attend meetings and conferences as appropriate. Prepare results of research and present as posters or scientific presentations at meetings and conferences as appropriate. Participate in own and others appraisals Undertake mandatory and priority training within the required time scales Work to NMC Code of Conduct and fulfil the requirements to maintain and revalidate registration Staff Management and Development To act as a leader, resource and role model taking responsibility for the supervision and management of the research nurses/midwives/AHPs and other staff To be responsible for ensuring all members of the research team undergo regular and effective appraisal, and to support appropriate training and development opportunities in line with role requirements. Support the revalidation of registered nursing/midwifery staff To be responsible for ensuring the on-going recruitment of staff and ensure that staff contracts are reviewed on a regular basis. Ensure the induction and development of staff To be responsible for the co-ordination of annual leave and all other leave for the research team, ensuring minimal disruption to the service provided by this team to patients. To facilitate and maintain effective communication within the research team. Maintain effective communication to disseminate information to your team ensuring that staff maintain current clinical and research knowledge