Clinical Trials Assistant
1 month ago
The focus of this role is towards meeting the needs of those who participate in clinical trials across the Trust. This role will involve working closely with the senior research nurses, research team, and all members of the multidisciplinary team to, thus facilitating and maintain a high quality research service. The post holder may be expected to interact with patients and their families in relation to the requirements of the clinical trials and be able to work without supervision in some areas. The post holder will be working within busy clinical trials departments with a portfolio of studies covering a range of conditions.
These trials are NIHR funded studies, commercial trails, and academic studies. Clinical trials support is provided to a team of Research Nurses. The post holder is expected to meet all reporting procedure timescales and international, national and local standards for clinical trial governance. 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(
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