Research Assistant

Trial Management Support Assist with the development and writing of trial specific procedures including development of Standard Operating Procedures (SOPs) relating to the management of the studies. Assist with the oversight and administration of Serious Adverse Events resolving queries, logging and reconciliation of events and notification of events to the relevant committees and authorities. Support with the preparation and submission of amendments and annual progress/safety reports to the Health Research Authority (HRA), Research Ethics Committees (RECs) and R&D departments. Attend trial and R&D meetings as required.

Assist with monitoring where required, and ensuring monitoring actions completed by study delivery teams. To attend R&D conferences and support with preparation and presentation of papers related to study delivery as required. Trial Coordination, Delivery, and Data Management Assist with the co-ordination and oversight of the day to day running and closure of the trial. Work closely with clinical study teams to ensure studies are conducted in line with the protocol and all applicable regulatory requirements.

Assist with the development and/or review other essential clinical research documents including patient information sheets/letters, informed consent forms as well as regulatory paperwork ensuring compliance with relevant SOPs, legislative requirements and guidelines in accordance to SWLSTG Policies and Procedures and Good Clinical Practice. Assist with the development of essential study manuals, and trackers including communications tools for the trial, e.g. drafting progress reports. Support data management..

Ensure all data for the trial is collected in line with the Research Protocol and study timelines. Collect informed consent from participants, arrange and perform semi-structured interviews (online or in person). Analyse the interview data under supervision. Assist with the management of online databases and provide technical support to trial participants.

Assist with data validation, producing reports and ensuring data is ready for analysis, in line with the study statisticians. Liaise with internal and external collaborators to facilitate data collection and analysis. Assist with the maintenance of the Trial Master File. Assist the Trial Manager, Chief Investigator and Statistician in writing the study related publication and final report.

To provide administration of clinical research throughout the project life cycle, from study set-up, initiation through to closure and archiving. To assist delivery staff, where required, to ensure that trial protocols are adhered to by all members of the multi-disciplinary team, ensuring follow up appointments and tests required are ordered and arranged. Administration Planning and supporting the meetings and work of the various groups and bodies associated with the trial. To extract clinical information from case notes, to receive clinical and scientific information from research collaborators and to input data accurately into the online database and research files.

This includes the appropriate handling and transmission of encrypted and personal data. Develop and maintain effective electronic filing systems. Undertake clerical/secretarial tasks as required by the research team. Provide cross cover for other CRU research projects where required.

Organise participant travel and book rooms for study appointments as required.