Research Coordinator

Job summary As an experienced Research Coordinator, you will act as the key coordinator for assigned clinical trials to proactively ensure the provision of a comprehensive, high quality and efficient administrative service.The purpose of this role is to coordinate the safe and effective delivery of high-quality research services and studies within the Primary Care setting.
The post holder will work to support relevant service development, the safe delivery and implementation of policy and procedures, and demonstrate effective professional standards, advocacy and performance.
The role involves using an in-depth knowledge of research protocols and their application in practice, alongside a working knowledge and compliance with the local, national and international research regulations.The successful candidate will utilise their excellent communication skills in liaising with a wide variety of audiences (multidisciplinary teams, service users, carers, commercial research organisations, the public and our internal clinical workforce.
Main duties of the job As the key coordinator you will proactively ensure the provision of a comprehensive, high quality and efficient administrative service.You are responsible for presenting research protocols to staff to encourage participation along with attending and contributing to project management group meetings for research, traveling around the country and region as required.Responsible for supporting and supervising workload allocation/ monitoring across the R&D and administrative team, escalating concerns to the line manager as appropriate.You will provide support to the Director of Research & Innovation with general workforce practices and queries , weekly work planning, annual leave coordination, recruitment and selection and the line management of the administrative team members.You will provide effective induction support and training to new and existing staff through 1:1 and group learning activities.Work closely with the Senior Research Management Team to implement new SOPs and working procedures within designated teams.
About us LAKESIDE HEALTHCARE is changing the face of primary care provision in England.
We are bold, adventurous and ambitious and determined to thrive in uncertain times.
We are the largest true partnership in the NHS and operate from various sites across the East Midlands.
We serve the healthcare needs of over 170,000 patients across Northamptonshire, Lincolnshire & Cambridgeshire.Caring & Respect: Simply put we genuinely care about people: working together for our patients and our teams, our patients come first in everything we do.Teamwork & Quality: In all areas of our business we network, collaborate and learn from our Patients, Stakeholders and each another to ensure we are always striving to improve, making the right and best decisions to provide the best service.About the Practice/Department/TeamWorking with a dedicated Research team based in Corby Health Centre which includes dedicated research GPs, Nurses, Business Manager, Research Coordinator and Clinical Research Assistants; currently working on a varied degree of clinical studies.
Job description Job responsibilities The purpose of this role is to co ordinate the safe and effective delivery of high quality research services and studies within the Primary Care setting.
The post holder will work to support relevant service development, the safe delivery and implementation of policy and procedures, and demonstrate effective professional standards, advocacy and performance.
The role involves using an in depth knowledge of research protocols and their application in practice, alongside a working knowledge and compliance with the local, national and international research regulations.The post holder will act as the key co ordinator for assigned clinical trials to proactively ensure the provision of a comprehensive, high quality and efficient administrative service.
This co-ordination ranges from inception and feasibility of proposed studies, completion and maintenance of the R&D capacity & resilience tool, the completion and submission of financial reports and accounts to demonstrate efficacy and value and the completion and maintenance of LHG Quality reports to ensure appropriate governance and quality assurance processes are in place, closely monitored and that risks are appropriately managed.The post holder will lead the work allocation and monitoring across these studies and associated staff the Research Team as well as their own workload comprising of trial co ordination and data management.
The post holder will also be responsible for providing line management support activities for any administrative team members, as required by the post holders line manager.The post holder will support the work of the Clinical Research Teams to ensure compliance with LHG Policy, Good Clinical Practice GCP and all other relevant requirements.Staff will be expected to continue to develop specialised skills and knowledge relating to the portfolio of research under their management.
The post holder will be expected to work flexibly in response to a continually changing portfolio of studies.In summary, the post holder will support the LHG Research & Development Team in the administration of clinical trials from feasibility to archiving including but not limited to:Facilitate the efficient and timely set up of clinical trials including financial negotiations.
Ensure tracking and payments of invoices for their clinical trial portfolio.
Ensure quality assurance of all trial related documentation in accordance with relevant legislation and guidelines.
Preparation for audit and inspections and implementation of action plans.
DUTIES AND RESPONSIBILITIESLHG TEAM SUPPORTResponsible for supporting and supervising workload allocation monitoring across theR&D and administrative team, escalating issues as appropriate to the line managerProvide support to the Director of R&I with general Human Resource HR activities, including but not limited to weekly work planning, annual leave co ordination, recruitment and selection and line management of the administrative team members.
This will be in accordance with LHG policies.
Provide induction support and training to new and existing clinical trials staff through one to-one and group learning activities.
Encourage the sharing of best practice and dissemination of information through attendance and contribution to the regular R&D team meetingsWorking with the Director of R&I, take a lead role in the data collection for metrics reports of key performance indicators.
This includes completion and maintenance of the R&D capacity & resilience tool, the completion and submission of financial reports and accounts to demonstrate efficacy and value and the completion and maintenance of LHG Quality reports to ensure appropriate governance and quality assurance processes are in place, closely monitored and that risks are appropriately managed.CLINICAL TRIALS CO-ORDINATION/ DATA MANAGEMENT:The specific responsibilities include:-Act as a key point of contact with the core Research and Development team, studysponsors, clinical research organisations and specific research teams across LHG.
Support feasibility activities for new studies under direction from senior managers and Principal Investigators.
Manage the set up and initiation of allocated clinical trials within the LHG sites and provide support for teams as requiredWorking with the Director of R&I, support with negotiations of study set-up costs and income recovery for assigned clinical trials in conjunction with the R&D & LHG Finance teams Oversee maintenance of investigator site files and essential documentation in accordance with ICH GCP and LHG Standard Operating Procedures SOPs to ensure they are kept inspection ready at all times.
Oversee and process trial amendment submissions in accordance with ICH GCP and LHGSOPs and timelines, escalating any delays with the line senior managers as appropriate.
To ensure that there are the appropriate administrative processes in place to capture and report any adverse event incidents including form completion, reported within study protocol and followed up to resolution as the study protocol and regulations require.
Implement and coordinate reporting mechanisms to ensure that research staff complete and return proformas containing up-dated information on patients included in the study.
Oversee and complete case report forms and participate in monitoring visits as per sponsor requirements.
Liaise with internal staff and external collaborators to resolve queries.
Provide information for senior managers including but not limited to case report formcompletion timeliness, data locks, data backlogs, work allocations and patient recruitment.
Ensure that data is available and up to date for any meetings related to the trial study, producing minutes as required.
Attend project related meetings, investigator meetings or teleconferences, as necessary to convey the relevant information to the study teams.
Lead on the preparation for audit and inspections within assigned studies, overseeing the implementation of action plans.
Ensure that all documents are archived in the appropriate way by following LHGarchiving guidelines, ensuring compliance with GDPR and Information Governance standardsUndertake general administrative tasks as delegated by the Director of R&I or LHG managerial representatives to contribute to the smooth running of the R&D serviceWORKING PRACTICEWork closely with the Senior Research Management Team to implement new SOPs and working procedures within designated teams.
Be pro-active in providing feedback on working practices within the research team and suggest new ways of working.
The post holder is expected to use initiative and be able to work independently without close supervision.
They are also expected to plan and organise their own time and workload activity with prioritisation, referring to senior managers as necessary.
The post holder is guided by relevant protocols and SOPs, and expected to exercise judgement outside these areas.CommunicationThe post requires excellent communication skills, being able to communicate effectively with a wide variety of audiences such as multidisciplinary teams, service users, carers, and commercial research organisations, the public, regional and national organisations where these will be of all levels of seniority.Facilitate effective communication of complex study information with all relevant research personnel, including: medical, nursing, administrative and pharmacy stuff at an appropriate level of understanding of the range of audiences specified.To present research protocols to staff to encourage participation.To attend and contribute to project management group meetings for research, traveling around the country and region as required.To keep and maintain accurate study specific records to meet audit requirements.Personal Development TrainingTo undertake and keep up-to-date with LHG and research mandatory training within the specified timeframe as specified.Demonstrate specialist knowledge in research area and support and encourage other staff in developing expertise and skills in this area.Recognise and use spontaneous and formal learning opportunities and share knowledge and experience with other staff.To contribute to the Development Review appraisal process and work towards agreed personal objectives.Other specific dutiesThe post carries a degree of autonomy with respect to the management of individual research projects.
Therefore each post holder is expected to be working towards a good working knowledge of the current standards, guidelines, and principles that govern research as well as good IT skills in Microsoft applications.This post also carries a degree of autonomy with respect to time management.
The exact nature of the duties will depend on a range of factors including the nature of the research study and the qualifications and experience of the post holder.The post holder will be required to travel throughout the services covered by LHG and on occasion, to regional and national meetings.
Therefore it is essential that the post holder has access to a vehicle and have a full UK driving licence.To undertake any other duties, which may be required from time to time, as are consistent with the responsibilities of the grade and needs of the service.PHYSICAL, MENTAL AND EMOTIONAL EFFORT Long periods of time spent using keyboard to input information and use of VDU for electronic communication.
Prolonged concentration is regularly required when checking through trial documentation and entering data into spreadsheets.
Occasional exposure to distressed circumstances as trial patients can be suffering from chronic or terminal illnesses.
Person Specification Experience Essential Significant experience in clinical trial administration and clinical trial data management.
Experience of mentoring and supporting junior staff Desirable Previous experience of working in Primary Care, the NHS or other healthcare system Line management experience Qualifications Essential Degree in a science or health related discipline or relevant experience in scientific and medical research.
Desirable Post graduate certificate in clinical research or other relevant post graduate qualification.