Overview
Clinical Trials Office Operations Administrator – Strand, London, WC2R 2LS
About us
The King’s Health Partners Clinical Trials Office is a collaboration between King’s College London, Guy’s & St Thomas’ NHS Foundation Trust, King’s College Hospital NHS Foundation Trust and South London and Maudsley NHS Foundation Trust. It was 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.
About the role
To provide administrative support to the KHP-CTO, which includes the Commercial and Non-Commercial Teams.
The post holder will provide support to the Commercial Team to manage Research Amendments, including the review, processing and approval of amendments.
The post holder will act as the primary contact within the KHP-CTO for the review and negotiation of Confidentiality Disclosure Agreements (CDAs) across all therapeutics areas.
The post holder will provide logistical, practical and administrative support to non-commercial research team as required according to KHP-CTO SOPs, prevailing regulations and best research practice.
Key objectives – Commercial
- To facilitate the collection and preparation of documentation for open commercial trials, including review of amendments, requesting support departments and issuing approvals.
- To assist in maintaining records of the clinical trials portfolio of the partners organisations
- To manage the shared amendments email inbox
- To upload documents into EDGE and perform quality checks
- To act as the primary contact for the negotiation of CDAs across all therapeutic areas
Key Objectives – Non-Commercial
- To assist the KHP-CTO Non-Commercial Team and R&D/Governance staff in the partner institutions to ensure that all trials sponsored or co-sponsored by the partner organisations are conducted in accordance with the Medicines for Human Use (Clinical Trial) Regulations 2004 (as amended) and the KHP-CTO SOPs.
- To use initiative and a problem-solving approach to carry out delegated tasks with minimal supervision in a timely fashion, requiring high levels of personal organisation and communication skills and a full understanding of the clinical research environment and working knowledge of the applicable law and local processes.
- To be the primary contact point for the receipt of Pharmacovigilance reports, and ensure these are acknowledged, followed up and escalated as appropriate within the strict framework of the regulations and KHP-CTO PV.
Communication & networking
- To build relationships and liaise with the relevant colleagues in the partner institutions using verbal, written and electronic mediums.
- To act as an ambassador for the KHP-CTO.
- Documenting and tracking any site communication.
Decision making, planning & problem solving
- Apply a problem-solving approach to assist the Teams in the resolution of any related problems.
- To assist in the maintenance and review of Sponsor records of the Clinical Trial Portfolio to ensure completeness, to include filing and logging of technical documents (requiring a full understanding of the clinical trials processes), where applicable following up missing documents by identification of, and liaison with the appropriate department or individual.
Service delivery
- To promote a quality approach to the conduct of clinical trials.
- To be responsible for the receipt of Pharmacovigilance reports, including tracking and follow up with site staff, KHP-CTO quality Team and relevant competent authorities in a timely fashion, thus ensuring compliance with the KHP-CTO Pharmacovigilance Policy and applicable regulations.
- To assist in the maintenance and review of Sponsor records of the Clinical Trial Portfolio to ensure completeness.
- To undertake such other duties within the scope of the post as may be requested by their head of department.
- To ensure confidentiality of commercially sensitive information
- To ensure data protection imperatives are respected
- To be responsible for the receipt of clinical trial amendments
Analysis & research
- Entering and maintaining trial data into the KHP-CTO trials databases.
- To run QC checks on KHPCTO Databases and alert line management to patterns suggesting systematic errors
Teamwork, teaching & learning support
- To maintain a working knowledge of prevailing regulations, guidance, best practices and clinical QA standards regarding the conduct of clinical trials
- Participate in internal education and training.
- To work flexibly as a member of the team.
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 QC checks
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
This is a full time (35 hours per week), and you will be offered fixed term contract until 30/11/2028
