KNOWLEDGE, SKILLS AND EXPERIENCE REQUIRED Qualifications Literate and numerate Good standard of education to a minimum of GCSE le.....
KNOWLEDGE, SKILLS AND EXPERIENCE REQUIRED Qualifications Literate and numerate Good standard of education to a minimum of GCSE level Experience Previous administrative experience IT skills Familiar with the process of clinical trials Training Willing to undergo training as required Specialist Knowledge Insight into role and responsibilities of post Disposition/Attitude Able to work as part of a multidisciplinary team Committed to working with people Practical Skills Good interpersonal skills Effectively communicate with multidisciplinary team members CORE BEHAVIOURS AND SKILLS Motivated Professional attitude and behaviour Able to adapt to service led changes Flexible approach to working practices and duties Able to work on own or as part of a team Attention to detail Good time keeping Time management skills Organisation skills Able to use own initiative Good written and oral communication skills with the ability to communicate with staff at all levels Reliable, trustworthy and honest approach to work and colleagues Fair approach when dealing with colleagues and team CORE KNOWLEDGE AND UNDERSTANDING The post holder will ideally have an understanding of the principals of clinical research and be expected to develop a working knowledge of clinical research. The post holder will have the ability to comply with ICH GCP guidelines for clinical research as well as the LTH Trust guidelines and policies. The post holder will ideally be familiar with the process of clinical trials and be willing to undergo further training as required to gain the knowledge shortly after entering the post. PRINCIPAL DUTIES & AREAS OF RESPONSIBILITY Patient support; To assist in the evaluation of patient eligibility, in liaison with other appropriate health care professionals for clinical trial entry, involving the co-ordination of tests, obtaining results and arranging transport and documentation of specific specimens as per clinical trial protocols To assist the co-ordination of the patients journey through the clinical trial protocol e.g. requisition and organisation of any necessary investigations, procurement of patient notes. Team Working; To ensure that all members of the multidisciplinary team are aware of the current trials portfolio; status of studies, and any trial amendments. To provide feedback to MDT members on issues relating to recruitment, protocol amendments and trial results. To disseminate information from Senior Research Nurse/Midwife to the MDT. The post holder will demonstrate the ability to manage their own administrative case-load, working as part of the multidisciplinary team. In conjunction with all members of the research team and appropriate healthcare professionals, develop a cohesive and flexible team working environment across the service. Arrange departmental meetings, including booking venues, sending out papers and taking minutes Administration; To coordinate the maintenance of all documentation required in site files, including archiving arrangements. . To assist with the collection and collation of trial data and completion of trial documentation in accordance with trial protocols. To ensure that all data entry is compliant with protocol requirements. To ensure that all trial data is submitted to the study sponsor within the specified time constraints. To manage and respond to any data queries received. To ensure timely entry of recruitment figures to all relevant data bases. To report monthly to the Senior Research Nurse accrual data on all patients recruited into the study portfolio highlighting local activities that might impact on achievement of the departments aims. Maintain an agreed level of supplies required across the clinical trials team and complete orders in line with departmental requirements General; To contribute to the development of the portfolio of trials. To help implement local and national and international quality standards, professional standards, recommendations and guidelines from national reports. The post holder will adhere to the Data Protection Act and maintain patient confidentiality at all times. The post holder will act in a professional manner at all times when dealing with patients, their relatives and representatives from both external and internal sources. The post holder will deal with telephone enquiries from staff, patients and carers ensuring that appropriate personnel are informed in order for actions to be taken. The post holder will be expected to represent the research team in a professional manner at meetings and events. The post holder will be expected to work to ICH GCP guidelines at all times. As a new post holder, an induction and training programme will be provided for key aspects of this role, however the post holder will be expected to take advantage of opportunities to attend meetings and workshops to enhance their knowledge of Clinical Research and clinical care. The staff member will ensure that (s)he follows the Trusts hospital infection prevention and control policies and procedures to protect patients, staff and visitors from healthcare-associated infections. He or she will ensure that(s)he performs the correct hand hygiene procedures, when entering clinical areas. To undertake any other duties deemed appropriate to the role, including interaction with patients and families when this is deemed appropriate. Health and Safety/Risk Management All staff are responsible for working with their colleagues to maintain and improve the quality of services provided to our patients and other service users. This includes complying at all times with the Leeds Teaching Hospitals NHS Trust Policies, including Health and Safety policies, in particular by following agreed safe working procedures, and reporting incidents using the Trust Incident Reporting system. Infection Control The jobholder must comply at all times with the Leeds Teaching Hospitals NHS Trust Infection Control policies, in particular by practising Universal Infection Control Precautions. Hand hygiene must be performed before and after contact with patients and their environment. Equality and Diversity The jobholder must comply with all policies and procedures designed to ensure equality of employment and that services are delivered in ways that meet the individual needs of patients and their families. No person whether they are staff, patient or visitor should receive less favourable treatment because of their gender, ethnic origin, age, disability, sexual orientation, religion etc. Patient and Public Involvement The Trust has a statutory duty to involve patients and public in evaluating and planning services. All staff have a responsibility to listen to the views of patients and to contribute to service improvements based on patient feedback. Training and Personal Development Continuous Professional Development The jobholder must take responsibility in agreement with his/her line manager for his/her own personal development by ensuring that Continuous Professional Development remains a priority. The jobholder will undertake all mandatory training required for the role. Respect for Patient Confidentiality The jobholder should respect patient confidentiality at all times and not divulge patient information unless sanctioned by the requirements of the role. COMMUNICATION & WORKING RELATIONSHIPS Internal: Consultants, All members of the clinical multidisciplinary team Lab Staff, Regulatory Committees, R & I, Research Nurses/Midwives, Management, Other Trust departments External: Pharmaceutical/Device Companies Clinical Trials Units e.g. MRC NIHR Clinical Research Network Other Trials Networks HRA Other Hospitals Universities
