At a Glance
- Tasks: Support clinical trials with administrative tasks and ensure compliance with regulations.
- Company: Join a collaborative team at King's Health Partners Clinical Trials Office.
- Benefits: Full-time role with a fixed-term contract until 2028, offering valuable experience.
- Other info: Inclusive workplace committed to diversity and personal growth.
- Why this job: Make a difference in healthcare by supporting vital clinical research.
- Qualifications: A-levels or degree in a related field; strong organisational and communication skills.
The predicted salary is between 36000 - 60000 £ per year.
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
About you
To be successful in this role, we are looking for candidates to have the following skills and experience:
Essential criteria
- Educated to \"A\" level or degree level preferably in a related subject area, e.g. a life science or clinical subject.
- Able to learn and work to SOPs
- Strong planning and organisational skills including the ability to prioritise 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.
- Knowledge of GCP full working knowledge of local regulatory requirements for the conduct of clinical trials.
- Experience acquired in administration role(s), preferably in either a pharmaceutical industry or clinical research setting, including specific experience of clinical trial administration.
Desirable criteria
- Understanding of Research Governance Framework, Ethics committee and Competent Authority approval processes.
- Understanding of medical terminology and practice
Downloading a copy of our Job Description
Full details of the role and the skills, knowledge and experience required can be found in the Job Description document, provided at the bottom of the page. This document will provide information of what criteria will be assessed at each stage of the recruitment process.
Further Information
We pride ourselves on being inclusive and welcoming. We embrace diversity and want everyone to feel that they belong and are connected to others in our community.
We are committed to working with our staff and unions on these and other issues, to continue to support our people and to develop a diverse and inclusive culture at King\'s.
As part of this commitment to equality, diversity and inclusion and through this appointment process, it is our aim to develop candidate pools that include applicants from all backgrounds and communities.
We ask all candidates to submit a copy of their CV, and a supporting statement, detailing how they meet the essential criteria listed in the advert. If we receive a strong field of candidates, we may use the desirable criteria to choose our final shortlist, so please include your evidence against these where possible.
To find out how our managers will review your application, please take a look at our \' How we Recruit \' pages.
Clinical Trials Office Operations Administrator in City of London employer: King’s College London
At King's Health Partners Clinical Trials Office, we pride ourselves on fostering a collaborative and inclusive work environment that values diversity and personal growth. Our commitment to employee development is reflected in our supportive culture, where you will have the opportunity to engage with leading professionals in clinical research while contributing to impactful health initiatives across London. With a focus on quality and compliance, we offer a dynamic role that not only enhances your administrative skills but also allows you to make a meaningful difference in the lives of patients through clinical trials.
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Trials Office Operations Administrator in City of London
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Join local community health events or volunteer for organisations like public health agencies. This not only builds your experience but also helps you network with industry professionals who might know of openings at places like King’s College London.
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We think you need these skills to ace Clinical Trials Office Operations Administrator in City of London
Some tips for your application 🫡
Highlight Your Relevant Experience:When applying for a role in health sciences administration, it's super important to spotlight any relevant experience you have in healthcare settings. Whether you've worked in a hospital, a clinic, or any related environment, make sure to detail those roles in your CV – focusing on your responsibilities and achievements that align with the job at King’s College London.
Showcase Your Administrative Skills:Administrative skills are key in this field, so don’t hold back! Make sure your CV reflects your proficiency in things like scheduling, data management, and compliance with health regulations. Mention specific software you’ve used, such as patient management systems, as this will demonstrate your hands-on abilities and readiness for the role at King’s College London.
Craft a Meaningful Cover Letter:Your cover letter should reflect your passion for the health sciences field and your eagerness to contribute to King’s College London. Share a bit about why you’re drawn to this sector, any impactful situations or challenges you’ve encountered, and how they’ve shaped your desire to work in health sciences administration. This personal touch can really set you apart!
Tailor Your Documents to the Job:Don't use a one-size-fits-all approach! Make sure your CV and cover letter are specifically tailored for this role. Highlight any certifications you have relevant to health administration, and ensure you clearly connect your previous roles to the skills needed for the full-time position at King’s College London. This way, you're showing them you’ve done your homework and are genuinely interested in being a part of their team.
How to prepare for a job interview at King’s College London
✨Showcase Your Administrative Skills
In health sciences administration, being organised is key. Make sure you can demonstrate your skills in managing schedules, paperwork, and data accurately. Be ready to discuss specific tools you've used, like electronic health record systems or scheduling software, and how they improved efficiency in your past experiences.
✨Know Your Regulations
Familiarity with healthcare regulations and compliance is crucial. Brush up on HIPAA, GDPR, or other relevant policies before your interview. We recommend preparing examples of how you've ensured compliance or handled sensitive information in past roles—this will show you're not just knowledgeable but also responsible.
✨Prepare for Scenario Questions
Interviews for administrative roles often involve scenario-based questions to assess your problem-solving skills. Practice responses to common situations you might face, such as dealing with a challenging patient or managing a sudden schedule change. This will not only demonstrate your ability to think on your feet but also highlight your interpersonal skills.
✨Align Your Goals with the Organisation
As a full-time candidate, employers will want to know how your long-term career goals align with their mission. Take some time to research King’s College London’s values and be ready to tie your passion for health sciences administration into their objectives. Demonstrating enthusiasm and career alignment can be a game-changer in this competitive field!
