About this role
Job summary
We are looking for a Coordinator to join our Original Research team based at Basildon Hospital.
The post holder will support the Original Research Lead in coordinating and providing advice and guidance for all staff across MSEFT with the development of original research, including advice and support on protocol development and the appropriate regulatory approvals required.
The post holder is expected to provide general administrative support to coordinate the overall management of MSEFT sponsored research projects, to ensure compliance with the relevant legislation and research governance requirements.
The post holder will aid in the development of an inclusive quality management programme across the 3 sites including the development and implementation of a suite of standard operating procedures (SOPs) and policies to demonstrate compliance with regulatory requirements e.g. MHRA, GCP, UK policy framework for health and social care research and ensure readiness for regulatory inspection.
Main duties of the job
Advise and support researchers in all aspects of research, including the application process and HRA requirements, communicating the requirements and motivating and persuading researchers, in order to ensure correct completion and submission of documentation
Coordinate the research processes for accepting and validating research applications, identifying any areas that are inconsistent or unclear and communicating with the researcher any changes or further information that is required
Support researchers to navigate national approval systems including Heath Research Authority processes, NIHR portfolio adoption process and other regulatory bodies including the MHRA, the Research Ethics Committee (REC) and the national Confidential Advisory group (CAG) etc.
Support audit of research studies and research office processes to ensure that research complies with Research Governance standards, including ethically approved consent processes, and Clinical Trials Regulations where applicable.
Assist with the processing of amendments for Sponsor Authorisation for Original Research and issuing notification of no objections for hosted projects where applicable in accordance with regulatory and research governance requirements.
Responsible for liaising with investigators to ensure that study files contain all study documentation as required by Good Clinical Practice (GCP)
About us
Our ambition is to deliver excellent local and specialist services, to improve the health and well being of our patients, and provide a vibrant place for staff to develop, innovate and build careers.
We aim to make the most of our skills and experiences so we can become the best we can be. As one organisation we will recruit the finest and retain more specialist staff due to more employment opportunities across our Trust.
Job description Job responsibilities
Are you looking for an exciting Original Research Coordinator role using your unique qualities, then we want to hear from you.
For full details about this varied and rewarding role, please see attached job description.
We look forward to your application.
Person Specification
Qualifications Essential
Educated to degree level or equivalent experience in a relevant subject area Evidence of GCP training
Desirable
Post Grad qualification Project management experience
Knowledge and Experience Essential
Significant knowledge of research processes and procedures/ experience in a clinical research environment Documented knowledge of relevant regulations and legislation
Desirable
Experience of basic audit, inspection, and /or monitoring of research data or documents Experience of contribution to R&D guidance documents and or developing IT data systems
Communication and Development Essential
Ability to communicate complex information - well structured and written application Evidence of high level planning and organisational skills - identified managing/prioritising workload/deadlines
Desirable
Familiarity with medical terminology - through education and/or work experience
Disclosure and Barring Service Check This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Employer details Employer name Mid and South Essex NHS Foundation Trust
Address Basildon
Nethermayne
Basildon
SS16 5NL
United Kingdom
Employer's website https://www.mse.nhs.uk (Opens in a new tab)