Research Administrator

1. Assist the clinical research team in co-ordinating a portfolio of 2. Participate in Good Clinical Practice (GCP) training and ensures GCP compliance of self and team. 3. Act as an expert resource with regard to trial administration procedures and guide other members of the research team. 4. Take a leading role in the study set up process including: - Assist in completing Expression of interest / study selection documents - Liaise with the study sponsor and research team to gather all relevant study information Prepare submissions for local research and development approval - Coordinate site initiation meetings - Set up the local site file and any relevant databases and documents for the study Consistently demonstrate the ability to work accurately 5. Take a leading role in on-going study coordination including: - Conduct regular site file maintenance to ensure study essential documents are version controlled and are maintained according to regulatory requirements - Maintain effective communication between the study sponsor and the clinical research team Support local implementation of study amendments - Update quality systems to record study information and enrolled patients details Coordinate and prepare documents for patient visits - Respond to patients/carers telephone calls (who may at times be distressed) tactfully and professionally Book trial specific investigations and procedures - Coordinate study monitoring visits - Support the research team with data queries and reporting as required 6. Take a leading role in study close out procedures including: - Liaise with the sponsor for final monitoring visit - Preparing study documents for archiving - Liaise with R&D and following archiving procedures 7. Assist the clinical research team to collect study data and ensure that data is transcribed accurately where required and as deemed appropriate by competency and study complexity. 8. Receive, handle, analyse and resolve data queries Direct unresolved queries to appropriate team member. 9. Support internal audit and monitoring. 10. Support external monitoring by coordinating monitoring visits between the clinical research team and study sponsors and prepare essential documents for review. Assist the research team to put in place any corrective action required following a monitoring visit. 11. Support appropriate studies within PHNT/UHP and its partner organisations as appropriate. Service Delivery and Improvement 1. Provide all aspects of general administration and clerical work for the clinical research team as required, including but not exclusively: - Document preparation Taking phone calls - Email and fax correspondence Typing letters - Maintaining databases Filing - Patient records requests and collection Gaining signatures - Office management (including electronic diary management) 2. Responsible for providing meeting support including coordinating meetings and taking accurate minutes. 3. Where applicable, oversee and provide support to Research Administration Support Staff, delegate appropriate tasks and ensure competency. Contribute to PDP. 4. Support the implementation of new quality systems and processes across the 5. Take responsibility for producing reports relevant to the specialty such as recruitment reports. 6. Contribute to service development by actively participating in admin team meetings. 7. Demonstrate an understanding of key performance indicators and support the clinical research team to achieve them. 8. Adhere to and contribute to the development of Standard Operational Procedures and Ensure that Admin Support Staff are aware of and follow departmental procedures. 9. Prioritise a busy workload and manage multiple tasks when frequently interrupted. 10. Provide cover during periods of absence for other trial administrators. 11. Treat all persons encountered during the course of duties with respect and courtesy and maintain a standard of conduct which best represents the clinical trials team and the Trust. 12. General reception duties as required. 13. Contribute to Patient and Public Involvement and Engagement activities across the department.