AddressJob id: 086425. Salary: £29,248- £32,181 per annum, including London Weighting Allowance.
Posted: 15 March 2024. Closing date: 24 March 2024.
Business unit: Research Management & Innovation. Department: KHP Clinical Trials Office.
Contact details: Sabeena Johal. sabeena.johal@kcl.ac.uk
Location: Multi Campus. Category: Professional & Support Services.
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Job description
The King’s Health Partners Clinical Trials Office (KHP-CTO) is a collaboration between King’s College London, Guy’s and St Thomas’ NHS Foundation Trust, King’s College Hospital NHS Foundation Trust and South London and Maudsley NHS Foundation Trust. It is set up to provide a single interface for those wishing to conduct Clinical Trials within the partner organisations, and to ensure that there are common, efficient processes for the set up and administration of Clinical Trials.
We wish to recruit a Clinical Trials Administrative Assistant, who will be an integral member of the King’s Health Partners Clinical Trials Office Commercial team. The post holder will provide administrative support to the Kings Health Partners Clinical Trials Office Commercial Team in management of the setup, governance and maintenance of commercial Clinical Trials.
This post will be offered on an indefinite contract.
This is a full-time post - 100% full time equivalent.
Key responsibilities
Key objectives
To facilitate the collection and preparation of documentation for the set up and administration of commercial Clinical Trials, and amendments to such
To assist in maintaining records of the Clinical Trials portfolio of the partners organisations
To manage an email inbox
To upload documents into EDGE and perform quality checks
To develop and maintain an understanding of prevailing regulations, guidance, best practices and GCP standards regarding the conduct of Clinical Trials
To ensure confidentiality of commercially sensitive information
To ensure data protection imperatives are respected
To undertake such duties within the scope of the post as may be requested by line management
Communication & networking
To communicate with all departments with the Partner Organisations to assist the Facilitator Team in the setup of and running of commercial Clinical Trials
To field routine enquiries to relevant member of the commercial team
To provide basic advice on first steps to initiate trial set up
To develop good relationships with investigators' support staff with King's Health Partners to obtain swift responses for arranging meetings, obtaining signatures etc.
Decision making, planning & problem solving
Apply a problem solving approach to assist the Facilitator Team in the resolution of site related problems
To use their initiative to ensure that stakeholders are rapidly put in contact with team members
To work with the Facilitator Team to prepare, organise and participate in departmental meetings
To be responsible for dealing with problems with equipment and materials at meetings
Service delivery
To ensure confidentiality of commercially sensitive information
To ensure data protection imperatives are respected
To assist with the logistical aspects of setting up and approval of commercial Clinical Trials
In conjunction with the Facilitator Team, visit Investigators and their trial teams across the partner institutions to support them in the conduct of high quality commercial Clinical Trials by providing practical assistance in the preparation of documentation, uploading material onto databases
obtaining signatures and preparing files as required.
To be responsible for the receipt of clinical trial amendments
To construct study related files and assist with archiving in accordance with KHPCTO SOPs
To use a problem solving approach whenever possible
To support the Facilitator Team in the delivery of problem solving wherever possible
To undertake such other duties within the scope of the post as may be requested by the head of department.
Analysis & research
To enter and maintain trial data into the KHPCTO trials databases.
To run QC checks on KHPCTO Databases and alert line management to patterns suggesting systematic errors
Team work, teaching & learning support
To actively contribute to the Facilitator Team and the wider KHPCTO, working flexibly as a member of both teams
Sensory/physical demands & work environment
Office based
Required to travel regularly across London to the various sites
Required to travel nationally to attend meetings occasionally
Required to use a p.c. extensively
Required to enter data and upload documents onto KHPCTO trial databases and to perform 0': check
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.
Skills, knowledge, and experience
Essential Criteria
- Educated to GCSE-level or equivalent
- Strong planning and organisational skills including the ability to prioritize and manage multiple tasks
- Excellent interpersonal skills – tactful and able to deal with a wide range of people in an enthusiastic and helpful manner whilst being capable of firmly maintaining policies and regulations
- Problem solving skills – pragmatic and flexible approach whilst maintaining policies and regulations.
- Strong computer skills (proficient with MS WORD, Excel and web-based applications)
- Commitment to a quality culture
- A professional demeanour and high ethical standards
- Proactive approach
- Ability to understand and function in the different cultural environments of academics and clinical academia
Desirable Criteria
- Understanding of medical terminology and practice
- Knowledge of GCP full working knowledge of local regulatory requirements for the conduct of Clinical Trials.
- Understanding of Research Governance Framework, Ethics committee and Competent Authority approval processes
- Experience acquired in administration role(s), preferably in either a pharmaceutical industry or clinical research setting, including specific experience of clinical trial administration
