Experienced Research Coordinator

9 months ago

Corby, United Kingdom Lakeside Healthcare Group Full time

This co-ordinationranges from inception and feasibility of proposed studies, completion and maintenance of theR&D capacity & resilience tool, the completion and submission of financial reports and accounts todemonstrate efficacy and value and the completion and maintenance of LHG Quality reports toensure appropriate governance and quality assurance processes are in place, closely monitoredand that risks are appropriately managed. The post holder will lead the work allocation and monitoring across these studies and associatedstaff (the Research Team) as well as their own workload comprising of trial co-ordination and datamanagement. The post holder will also be responsible for providing line management supportactivities 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 withLHG Policy, Good Clinical Practice (GCP) and all other relevant requirements.

Staff will be expected to continue to develop specialised skills and knowledge relating to theportfolio of research under their management. The post holder will be expected to work flexiblyin response to a continually changing portfolio of studies. In summary, the post holder will support the LHG Research & Development Team in theadministration 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 RESPONSIBILITIES LHG TEAM SUPPORT Responsible for supporting and supervising workload allocation/ monitoring across theR&D and administrative team, escalating issues as appropriate to the line manager.

Provide 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, recruitmentand selection and line management of the administrative team members. This will be inaccordance 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 throughattendance and contribution to the regular R&D team meetings.

Working with the Director of R&I, take a lead role in the data collection for metrics reportsof key performance indicators. This includes completion and maintenance of the R&Dcapacity & resilience tool, the completion and submission of financial reports and accountsto demonstrate efficacy and value and the completion and maintenance of LHG Qualityreports 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 andPrincipal Investigators.

Manage the set up and initiation of allocated clinical trials within the LHG sites and providesupport for teams as required. Working with the Director of R&I, support with negotiations of study set-up costs andincome recovery for assigned clinical trials in conjunction with the R&D & LHG Financeteams. Oversee maintenance of investigator site files and essential documentation in accordancewith ICH-GCP and LHG Standard Operating Procedures (SOPs) to ensure they are keptinspection ready at all times.

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