Detailed job description and main responsibilities

To act as an expert resource and is responsible for ensuring all elements of study set up are completed in accordance with UK and EU legal requirements,

Ensure all studies have the required documentation and arrangements in place prior to providing R&I approval confirming the Trust’s readiness to recruit.

Manage the potentially conflicting demands of governance approval of the capacity and capability (R&I approval) of multiple research projects in collaboration with the research delivery team and Research Operations Manager.

Oversee a register of ICH-GCP training and Research-CVs for all research staff

Establish, evaluate and update existing Trust policies and Standard Operating Procedures (SOPs) including the development of new local polices and SOPs in accordance with national legislation for research and recommendations from regulatory authorities such as Health Research Authority (HRA) and Medicines and Healthcare products Regulatory Agency (MHRA).

Ensure the implementation of research Standard Operating Procedures across the Trust in conjunction with the SOP Controller.

To keep all staff informed of any regulatory changes and its impact on the local research processes including sponsorship processes.

Collaborate with the R&I governance staff in contract negotiations. Ensure study protocol amendments are incorporated into research practice in a timely manner and any delay/hindrance in the enactment of the amendment, is brought to the attention of the study sponsor at the earliest and before the deadline.

Prepare, conduct and oversee the internal audit process of the department under the guidance of Head of R&I.Prepare, support and coordinate external regulatory inspections including responses to findings and implementation of subsequent action plans in liaison with Research Operations Manager.

Support the Chief Investigator (CI) in obtaining ethical permissions, including completing IRAS / MHRA, local ethics and HRA submissions and support the process for Trust sponsored studies.

As directed by Head of R&I, ensure regular invoicing in line with contractual agreements, in a timely manner and provide study finance support to raise timely invoices in line with contractual agreements and to ensure accurate records are maintained for finance associated with studies.

Assist in negotiation / co-ordination of costing information and development of systems (e.g. EDGE finance workflows and forms) to track / forecast potential costs.

Ensure costs are assigned to the appropriate budgets according to current R&I finance policiesAnalyse, investigate and resolve study income queries including liaising with the finance department.

Contribute to the development and validation of systems e.g. electronic data capture platforms, in the R&I department to provide effective support in the set-up and delivery of research and innovation.

Support the development of home-grown studies and grant applications, including IRAS submission.

Contribute to the professional and educational development of staff by identifying and facilitating training opportunities in conjunction with Research Training lead, where appropriate.

Ensure the archiving of study related documentation in line with the Trial Agreement and ICH-GCP / ISO 14155 / Trust and departmental Archiving and Off-Site Polices.

Contribute to the creation and maintenance of content on the R&I website and intranet pages ensuring information provided is accurate and up to date

Assist in the development of marketing material to promote FHFT’s research and innovation and to improve engagement of staff, patients and public in it.

Support R&I team to promote research at FHFT to internal and external stakeholders through events and training.

Assist in Patient, Public, Involvement and Engagement (PPIE) activities of R&I.