Original Research Coordinator

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)

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.