Research Administrator

Job overview

We are looking for a highly motivated individual with proven ability in administration, data management and data entry to join our Clinical Support Team within Research & Development. This is an exciting opportunity for a self-motivated and enthusiastic individual with excellent organisational and communication skills and exceptional attention to detail to join our large multidisciplinary team supporting our Clinical Research staff in all aspects of administrative and data entry activities. If you are looking for a new challenge and to be part of a growing team then this could be the opportunity you are looking for. You will be fully supported with training from our experienced research team. If you are interested and would like to know more about the role, please contact:  Tash Winter – Clinical Administration Manager – 01752 432258  [email protected]

***Please note that we would also welcome secondment requests*

The University Hospitals Plymouth Research & Development department is based at Plymouth Science Park across two buildings. Potential candidates need to be aware that there are distances they will need to be able to cover between the buildings and the different research clinics based in the main hospital site.

Main duties of the job

The post holder will work as part of the R&D Clinical Support team delivering administration and data entry support for the departments research portfolio of commercial, non-commercial and academic clinical trials supporting the safe conduct of research in accordance with the Research Governance Framework and Good Clinical Practice guidelines and provide assurance that the rights, safety and well-being of trial participants are protected.

***Preference will be given to internal Trust staff, as well as ‘Priority’ and 'At Risk' status including NHS At Risk staff throughout Devon who are able to display recent relevant experience as dictated by the Person Specification.***

Detailed job description and main responsibilities

Research and Governance

• Assist the clinical research team in co-ordinating a portfolio of studies.
• Participate in Good Clinical Practice (GCP) training and ensures GCP compliance of self and team.
• 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

• 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

• 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

• Assist with data entry according to study complexity and ensure that data is transcribed accurately where  required.
• Support internal audit and monitoring.
• Support appropriate studies within PHNT/UHP and its partner organisations as appropriate.

For further details please see attached JD&PS.