The post holder will primarily manage activities relating to the randomisation service and electronic data capture (EDC) system, such as taking responsibility for user access and password management, data export, circulating documents for signature, receiving and processing Serious Adverse Event (SAE) forms relating to a portfolio of trials, reviewing the content of such notifications and processing them according to regulatory requirements, co-ordinating of King?s Trials Partnership activities and managing document version control and tracking within the KCTU.
QualificationsDegree level qualification or equivalent professional experience (a subject with either a major health related component e.g. biology, psychology, or of relevance to administration e.g. accounting, business management, NHS management would be desirable
SkillsTo act as the main point of contact for approximately 100 clinical trial teams currently using the KCTU randomisation service and electronic data capture system (EDC)
- To process requests for user access to IT systems supporting the KCTU portfolio of trials accurately and promptly, with due care and attention
- Manage activities relating to randomisation and EDC system, keeping accurate auditable records
- To process Serious Adverse Event (SAE) reports in accordance with KCTU SOPs
- Occasionally, to process Emergency Code Break notifications in accordance with KCTU SOPs
- To receive and resolve queries relating to the above during the life of each project
- To provide administrative support to the King?s Clinical Trials Unit Operational Director and Business Manager along with other KCTU staff as needed
- Manage activities of the KCTU in line with KCL policy and procedures and with the Standard Operating Procedures of the Clinical Trials Unit
- To participate in inspections of the KCTU by sponsor auditors, regulatory authorities and others, ensuring key documents are readily available
- To ensure that the KCTU?s website is kept up to date and that the information is accurate
- Responsible for providing a professional, accurate and efficient service to a wide range of people including study teams, colleagues and external agencies
- Ensure compliance with GCP, regulatory legislation and ethical frameworks in respect of working practices
- Liaise with a wide range of internal and external clients to ensure requests for user access to KCTU IT systems are processed swiftly, which will involve explaining complicated procedures on how to obtain access
- Being mutually supportive and covering duties as necessary during colleagues absences and at time of additional pressure, as directed
The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope and grading of the post.
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