Research Administrator - Plymouth, United Kingdom - University Hospitals Plymouth NHS Trust

Tom O´Connor

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Tom O´Connor

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Description
Research and Governance1. 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 documentsLiaise with the study sponsor and research team to gather all relevant study information Prepare submissions for local research and development approvalCoordinate site initiation meetingsSet 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 requirementsMaintain effective communication between the study sponsor and the clinical research team Support local implementation of study amendmentsUpdate quality systems to record study information and enrolled patients details Coordinate and prepare documents for patient visitsRespond to patients/carers telephone calls (who may at times be distressed) tactfully and professionally Book trial specific investigations and proceduresCollecting prescriptions or investigation results Coordinate study monitoring visitsSupport 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 visitPreparing study documents for archivingLiaise 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 the implementation of new quality systems and processes across the department.4. Contribute to service development by actively participating in admin team meetings.5. Recognise the importance of key performance indicators and support the clinical research team to achieve them.6. Recognise the importance of and adhere to Standard Operational Procedures and policies without supervision.7.

Prioritise a busy workload and manage multiple tasks when frequently interrupted.8. Provide cover during periods of absence for other trial administrators.9.

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.10.

General reception duties as required11.

Contribute to Patient and Public Involvement and Engagement activities across the department

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