Senior Research Administrator
1 week ago
The Research Administrator role would be an excellent starting point for someone interested in pursuing a career in clinical research management.
- Assist the research governance and quality assurance team in coordinating a portfolio of studies.
- Participate in Good Clinical Practice (GCP) training and ensures GCP compliance of self and team.
- Provide all aspects of general administration and clerical work for the clinical research team as required.
- Act as an expert resource with regard to trial administration procedures and guide other members of the research team.
Joining University Hospitals Plymouth NHS Trust means becoming part of a team of dedicated staff, who are committed to leading the way through innovation, clinical excellence and great customer care.
The Trust has great opportunities for career development in a highly progressive working environment. We offer all of this in a vibrant, modern city with a historic reputation for adventure.
Preference will be given to internal Trust staff, as well as 'Priority' and 'At Risk' status including NHS at Risk staff throughout Devon who is able to display recent relevant experience as dictated by the Person Specification.
- Take a leading role in the study set up process including:
Prepare submissions for local research and development approval
Coordinate monitoring with clinical teams and the Principal Investigator
Set up the local site file and any relevant databases and documents for the study
- Take a leading role in ongoing study coordination including:
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 monitoring visits
Respond to patients/carers telephone calls (who may at times be distressed) tactfully and professionally
Coordinate study monitoring visits
Support the research team with data queries and reporting as required
- Take a leading role in study close out procedures including:
Preparing study documents for archiving
Liaise with R&D and following archiving procedures.
- As required,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.
- As required,receive, handle, analyse and resolve data queries promptly. Direct unresolved queries to appropriate team member.
- Support internal audit and monitoring.
- Provide all aspects of general administration and clerical work for the clinical research team as required.
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