Research Data Administrator- Band 3
2 weeks ago
To be responsible for providing a high quality data administrative services to the department of Clinical Research (DoCR) in order to ensure the smooth running of a range of clinical trials and other research projects.
To be responsible for the entry of all allocated trial related data into the relevant electronic and paper data capture systems in compliance with the trial protocol.
To provide cover for core administrative duties within the DoCR as required.
The post holder will be responsible for providing high quality data management support. The post holder will be based within a friendly and established team managing oncology studies and across the wider Department of Clinical Research.
The successful applicant will demonstrate highly effective interpersonal skills, including communication and negotiation skills; together with the ability to work effectively and cohesively with a wide range of clinical and non-clinical staff within the Trust and the wider NIHR network.
If you are interested in working within research and making a difference this could be the job for you.
Clinical Research Department provides research governance, management, delivery support, and advice across the whole Trust in all matters that relate to research and development. The current workforce is structured into two main teams with distinct functions Research governance and Research Delivery however the teams work closely together as one department.
**Our department Vision is**: To support ground-breaking research, working with our partners to improve the health of our communities.
**Our department mission is**: To embed a culture of research excellence throughout the Trust where all colleagues feel they can contribute to the delivery of research, and support the development of our own highly skilled research specialists.
Communication & Working Relationships
The post holder will demonstrate highly effective interpersonal and communication skills together with the ability to work effectively and cohesively with a wide range of clinical and non-clinical staff within the department and also with external study organisers.
The post holder will communicate with external study centres and monitors.
To work closely with the research nurses and clinicians where necessary to ensure that all data are captured for patients on clinical trials and question/complete missing fields
Attend necessary training courses and meetings with peers in the South West and also nationally.
Following training, carry out and take telephone calls from trials’ patients or their relatives and deal sensitively and in a professional manner at all times.
Data Management
To be responsible for the input of clinical and other data necessary for clinical trial purposes
Checking all data is accurately populated, ensuring all empty data fields are completed to ensure data quality, completeness, validity, consistency, timeliness and accuracy to ensure the data is appropriate for its specific use within the study.
Maintain and update Databases used for all aspects of the patient pathway experience within Portfolio clinical research studies. This includes Microsoft Excel, and on line web databases.
Maintain spread sheets/database on patient recruitment
Responsible for the inputting data into EDGE ‘Intelligent Research Management system’ Extract data from information systems and prepare summaries to support regular clinical audit, update reports as requested
Responsible for forwarding completed data and data queries to trials unit (or sponsor)
Maintenance of robust systems to track and monitor patient and financial progress through clinical trials.
To be responsible for the electronic or paper entry of the Case Report Forms (CRFs) in line with the agreed timelines within the Clinical Trial Agreement (CTA) for commercial sponsors and local SOPs for Non-Commercial studies
To be responsible for liaising with Clinical Trials Units (Sponsor) regarding data queries and for checking/resolving data queries
To be responsible for liaising with research nurses and commercial trial sponsors to ensure complex data issues are resolved
To have a basic understanding of the activities associated with each trial that is allocated to the post holder eg financial processes & implications of data entry delay or inaccuracy
**To utilise the Trust’s IT systems eg**: Mosaiq; Maxims; Order Comms; EPRO, etc in order to access relevant information for trial data collection purposes
Uploading of digital images required by sponsors.
To produce status updates when requested by the other member of the Research Team, eg of the numbers of patients
To comply with the Trust’s policy on Data Protection, Confidentiality and security.
Planning & Organisation
Advanced organisational skills are required to manage several projects at various stages of development concurrently.
To be involved in the setting up of new trials particularly where the post holder may be involve
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