• Performing study initiation activities and routine monitoring visits, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provide training on completion of the eCRF; monitoring activities and study close-out activities. • Identifying and evaluating the capability of potential sites to successfully manage and conduct the clinical study, both clinically and technically. • Working with study staff to coordinate activities with the site in preparation for the initiation of studies. Obtain and organise regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. • Managing progress by tracking regulatory submissions, recruitment, case report form completion and data query resolution.• Set up, management and maintenance of the Trial Master Files (TMF), or eTMF, in accordance with GCP• Support the clinical team with the preparation of essential clinical trial documentation, ensuring distribution, tracking and filing of documents as applicable.• Management and maintenance of essential documents and trial supplies• Assist with the setup of Investigator Site File (ISF) for early phase studies.

• Study setup and amendment management – including applications and submissions to Ethics committee, MHRA, and Research Governance.• Member of the internal monitoring and audit team – monitoring of study documentation to ensure compliance with protocol and GCP• Designing local source documents and CRFs• Coordinate and action matters arising from facilitation group meetings, liaising with Principal Investigators and associated staff to increase trial activity.• Carry out clinical procedures in accordance with Trust policies such as; taking vital signs, ECG recording and phlebotomy.• Coordinate the care of my own case load of clinical trial patients, check eligibility of patients into trials and ensure all relevant data has been recorded accurately. • Operationally line manage trial support staff, who collect and enter trial data, managing their workload and priorities, within and between projects.• Act as point of contact with commercial companies to organise and attend site selection/initiation visits, with a view to the site being chosen to run the research project.

Liaised and supported Chief Investigators, Principal Investigators and other key research personnel in progressing research activities.Coordinated study setup including assisting in the preparation of documents in order to gain local regulatory committee approval (ethics and R&D approval) and liaising with Trust R&D teams to ensure research agreements/contracts were in place.Managed an appointments diary for meetings and teleconferences involving primary care delivery staff and making appropriate arrangements e.g. Booking rooms, organising refreshments, travel arrangements, etc.Maintaining all study files and documentation, booking patient appointments, sending appointment reminders and booking and attending site initiation visits.

Job Purpose: To conduct laboratory-based scientific research in islet biology with the aim of developing new strategies for the treatment of diabetes.Key Duties:Contribute to the laboratory’s current research programme by providing technical support to other scientists, including processing of human tissue, maintenance of primary cell cultures and cell lines and sample analysis e.g. immunoassays, immunocytochemistry. Participate in the on-call rota for isolation of islets and other cells from human pancreatic tissue and the collection of tissues from other sites for use in research.Conduct statistical analysis of data and compilation of reports for discussion at laboratory meetings.Collate research findings for presentation and/or publication within the scientific community, nationallyand internationally.Perform administrative duties associated with research activities, for example stock control, writing andupdating SOPs.

• Carry out duties in accordance with GCP and GLP (ICH GCP and local regulations.• Work in accordance with Health and Safety and COSHH regulations to ensure meticulous recording of data in both clinical and research notes.• Maintain accurate Biological sampling freezer Logs, Specimen Labelling, processing and dispatch documentation.• Perform Quality Control checks of all laboratory documentation/source data entry and correct errors promptly; Work with monitors and Data Co-ordinator to ensure prompt corrections/answers to Data Queries.• Assist the RN with IMP/NIMP/Device checking, receipt, storage and temperature monitoring.• Maintain the clinical equipment calibration log files and coordinate the calibration visits in a timely fashion as per SOP requirements.• Maintain clinical trial supplies (kits, dry ice) and order appropriate clinical supplies.• Complete all relevant clinical competency training assessments.• Complete all mandatory and study specific training according to SOP’s

Diaspirin analogues, bowel cancer and cachexia (‘Di-ABC study’)For my sandwich year I participated in a study alongside Dr Steve Russell at Aston University, which investigated the evaluation of di-aspirin compounds in the treatment of colorectal cancer and cachexia. The role allowed me to experience first hand of working in a laboratory environment. I was able to put my current laboratory skills to the test whilst also picking up on new procedures. I worked in various laboratories where special precautions needed to be taken such as standard operating procedures and personal protective equipment. My main responsibilities included; re-establishing cell line from liquid nitrogen into media for preparation of cell viability assays and creating gels by following protocol for Western blot to be later used to detect proteins from a tissue sample. I am comfortable with the following techniques; cell culture, confocal microscopy, SDS-page gel electrophoresis, Western blot, ELISA, MTT assay and aseptic technique. Thus far I have developed skills in literature searching, concise report writing, observation, organization skills and lab book notation skills.