Research Administrator

Research and Governance 1. Assist the clinical research team in co-ordinating a portfolio of studies. 2. Participate in Good Clinical Practice (GCP) training and ensures GCP compliance of self and team. 3. With support, coordinate 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 4. 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 Collecting prescriptions or investigation results Coordinate study monitoring visits Support the research team with data queries and reporting as required Consistently demonstrate the ability to work accurately 5. 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 6. Assist with data entry according to study complexity and ensure that data is transcribed accurately where required. 7. Support internal audit and monitoring. 8. Support appropriate studies within PHNT/UHP and its partner organisations as appropriate. For further details please see attached JD&PS. Job description Job responsibilities Research and Governance 1. Assist the clinical research team in co-ordinating a portfolio of studies. 2. Participate in Good Clinical Practice (GCP) training and ensures GCP compliance of self and team. 3. With support, coordinate 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 4. 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 Collecting prescriptions or investigation results Coordinate study monitoring visits Support the research team with data queries and reporting as required Consistently demonstrate the ability to work accurately 5. 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 6. Assist with data entry according to study complexity and ensure that data is transcribed accurately where required. 7. Support internal audit and monitoring. 8. Support appropriate studies within PHNT/UHP and its partner organisations as appropriate. For further details please see attached JD&PS.