About this role
About the role
The Commercial Trials Facilitator is an integral member of the King’s Health Partners Clinical Trials Office Commercial team. The post holder will act as a key contact within KHP-CTO for all researchers, commercial companies and contract research organisations wishing to undertake commercial clinical trials within our Partner Organisations. The post-holder will of to align with the NIHR 150-day metric. The post-holder will conduct additional administrative tasks including but not limited to archiving, inbox management and processing modifications.
Key Responsibilities:
Collect and prepare the documentation required to confirm local capacity, collate regulatory approvals needed to instigate clinical trials and facilitate key set-up activities to align with the NIHR 150-day metric. Support delivery of the NIHR 150-day study set-up metric by proactively progressing study approvals, escalating delays and maintaining accurate milestone tracking data. Facilitate the collection of local and regulatory approvals required for the review and implementation of modifications. While managing shared inboxes, provide comprehensive advice to external and internal stakeholders for the conduct of clinical trials across the partner organisations. To assist in maintaining the records of the clinical trials portfolios of the partner organisations including the EDGE system and ensuring information added is quality checked. To ensure that trials metrics are collected and data is entered in a timely fashion, to permit tracking of milestones by updating shared trackers. To assist in the archiving of clinical trials documentation to meet prevailing regulatory requirements. To maintain a working knowledge of prevailing regulations, guidance, best practices, research governance frameworks and GCP standards regarding the conduct of clinical trials. To ensure confidentiality of commercially sensitive information and that data protection imperatives are respected 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) post, and you will be offered an indefinite contract
About you
To be successful in this role, we are looking for candidates to have the following skills and experience:
Essential criteria
Experience supporting the set-up, administration or delivery of commercial clinical trials, including management of trial documentation, approvals, study tracking systems or stakeholder communications Strong planning and organisational skills including the ability to prioritise and manage multiple tasks Excellent communication and 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 Demonstrably high levels of accuracy and attention to detail Demonstrable experience of managing competing priorities and delivering work accurately to tight deadlines within a target-driven environment Experience of clinical research administration within the NHS, Higher Education or pharmaceutical industry environment. Proficient in Microsoft Office applications, particularly Excel, and experience using databases, web-based systems or trackers to maintain accurate records and monitor performance metrics.
Desirable criteria
Demonstrates a commitment to a quality culture with a professional demeanour and high ethical standards Knowledge of GCP and full working knowledge of local and national regulatory requirements for the conduct of clinical trials Familiar with NIHR guidelines around clinical trial set-up timelines within the NHS.
Contact Person: Alexander Hickman
Contact Details: [email protected]