Site Start-up Specialist

locations Home Based - England - London (35 Hour Weekly Max)

time type Full time

posted on Posted Yesterday

time left to apply End Date: March 24, 2025 (7 days left to apply)

This vacancy may close earlier if a high volume of applications is received or once a suitable candidate is found, therefore we strongly recommend that you apply early to avoid disappointment. Please let us know if there is anything about the recruitment process that you would like to discuss, in particular if there are any changes or adjustments that would make it easier for you to apply. Please contact or as soon as possible.

Visa sponsorship: You must be eligible to work in the UK to apply for this vacancy. Cancer Research UK is not able to offer visa sponsorship.

Recruitment process: Competency based interview

Interview date: W/C 7th April 2025

At Cancer Research UK, we exist to beat cancer.

We're looking for a Site Start Up Specialist to join our clinical operations team which sits within Cancer Research UK's Centre for Drug Development (CDD).

CDD is the world's only charity-funded drug development facility. Our pioneering research is driven purely by the goal to see scientific breakthroughs bring benefits to patients sooner. CDD is the sponsor of early phase and precision medicine clinical trials in oncology agents. Our broad portfolio rivals that of a medium-sized pharmaceutical company, spanning antibodies, cell therapies, vaccines, drug conjugates and small molecules, making this an interesting and dynamic area to work in.

As a site start up specialist you will work within a multidisciplinary team on a selection of early phase clinical trials. Your focus will be to expedite site/investigator selection and to open sites to recruitment in the most efficient and expedited way possible, fully understanding the sponsor's requirements and timeline. You'll be a confident communicator and have the ability to develop good relationships with Investigators, project teams and site personnel to ensure that Cancer Research UK clinical trials are set-up efficiently, to budget and to time. You'll also work closely with our Clinical Research Associate (CRA) team on monitoring phase 1 and 11 clinical trials, supporting them with monitoring dependent on business need.

1. Research potential sites and provide a list of sites to be taken forward for full feasibility.
2. Discuss the requirements of the trial with the Clinical Study Manager (CSM) and Senior Site Start-up Specialist (SSSS).
3. Identify challenges that may need to be overcome by a site in order to take part in the clinical trial.
4. Draft, finalise and distribute feasibility questionnaires as deemed necessary by the CSM and SSSS and collate the responses. If required, they will ensure confidentiality agreements (CDAs) are in place before sending out confidential information.
5. Perform pre-study visits either in person or virtually in order to determine the responses to any feasibility questions or to address any concerns.
6. Present all findings and recommendations to the CSM and SSSS so a joint decision can be taken on suitable sites for the trial.
7. Work with the CRA assigned to the trial/site to ensure that the sites are successfully handed over which includes, but is not limited to, arranging/delivering the SIV, organising the document pack for sites and collating/approving all required documents.

1. Experience of site selection, site set-up and monitoring (if possible) of a clinical trial (oncology desirable but not essential).
2. Experience of working with clinical trials of investigational medicinal products (CTIMPs).
3. Working knowledge of oncology; the National Health Service; UK regulations; and the clinical trial application process.
4. An understanding of the relevant protocol investigations e.g. Response Evaluation Criteria for Solid Tumours (RECIST), Ionising Radiation (Medical Exposure) Regulations (IRMER); Advanced Therapy Medicinal Product (ATMP) Regulations.
5. Clear communicator; confident in speaking knowledgably with site staff; represent the Sponsor in a professional manner.
6. Good negotiation skills to support with the negotiation of costs and contracts.

Our organisation values are designed to guide all that we do.

Bold: Act with ambition, courage and determination

Credible: Act with rigour and professionalism

Human: Act to have a positive impact on people

Together: Act inclusively and collaboratively

If you're interested in applying and excited about working with us but are unsure if you have the right skills and experience we'd still love to hear from you.

We create a working environment that supports your wellbeing and provide a generous benefits package, a wide range of career and personal development opportunities and high-quality tools. Our policies and processes enable you to improve your work-life balance, take positive steps in your career and achieve your personal wellbeing goals.

We operate an anonymised shortlisting process in our commitment to equality, diversity and inclusion. CVs are required for all applications; but we won't be able to view them until we invite you for an interview.

Our vision is to create a charity where everyone feels like they belong, benefits from and participates in, the work we do. We actively encourage applications from people of all backgrounds and cultures, in particular those from ethnic minority backgrounds who are currently under-represented.

Unfortunately, we are unable to recruit anyone below the age of 18, so that we can protect young people from health & safety and safeguarding risks.

As the world's largest independent cancer research charity, we conduct research into the prevention, diagnosis and treatment of the disease. Our aim is to see 3 in 4 people survive cancer by 2034 and our staff are integral to achieving that ambition. Cancer Research UK offers you excellent prospects to expand your career as well as the ability to make a real difference to the lives of others.