Site Start-up Specialist

Site Start-up Specialist

£40,000 - £45,000 plus benefits

Reports to: Clinical Operations Manager

Directorate: Research & Innovation

Contract: Permanent

Hours: Full time 35 hours per week

Location: Home-based

Closing date: 23 March 2025 23:55

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 recruitment@cancer.org.uk or 020 3469 8400 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 UKs 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. It is an exciting time for CDD as we're expanding our teams to move forward with an ambitious new strategy to maximise the impact of our research to benefit patients.

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.

It is an exciting time for CDD as we're expanding our teams to move forward with an ambitious new strategy to maximise the impact of our research to benefit patients. Several teams are hiring new roles to make this new strategy a reality, expanding the size of our project portfolio and bringing in new skills as we work more internationally.

What will I be doing?

• Research potential sites and provide a list of sites to be taken forward for full feasibility

• Discuss the requirements of the trial with the Clinical Study Manager (CSM) and Senior Site Start-up Specialist (SSSS).

• Identify challenges that may need to be overcome by a site in order to take part in the clinical trial;

• 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;

• Perform pre-study visits either in person or virtually in order to determine the responses to any feasibility questions or to address any concerns, including those raised from previous collaborations with the site;

• Present all findings and recommendations to the CSM and SSSS so a joint decision can be taken on suitable sites for the trial, as well as being able to work across the project team;

• 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. This will be agreed on a site by site basis.

What are you looking for?

• Experience of site selection, site set-up and monitoring (if possible) of a clinical trial (oncology desirable but not essential);

• Experience of working with clinical trials of investigational medicinal products (CTIMPs)

• Working knowledge of oncology; the National Health Service; UK regulations; and the clinical trial application process (different requirements of the Devolved Nations is desirable but not essential as training will be provided)

• 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 (as needed), etc., this will vary from trial to trial;

• They must be a clear communicator; confident in to speaking knowledgably with site staff; represent the Sponsor in a professional manner;

• They must have good negotiation skills to be able 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

We're looking for people who can believe in and embody these organisation values and can use them to drive forward progress against our mission to beat cancer.

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.

What will I gain?

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.

You can explore our benefits by visiting our careers web page.

How do I apply?

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. Instead, we ask you to complete the work history section of the online application form for us to be able to assess you fairly and objectively.

For more information on this career opportunity please visit our website or contact us at recruitment@cancer.org.uk.

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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.

We want to see every candidate performing at their best throughout the job application process, interview process and whilst at work. We therefore ask you to inform us of any concerns you have or any adjustments you might need to enable this to happen. Please contact recruitment@cancer.org.uk or 020 3469 8400 as soon as possible.

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.