Study Start-Up Specialist

Job Title: Clinical Trial Set Up Specialist
Location: Sarah Cannon Research Institute (Hybrid)
Full Time 37.5 hrs/week. Monday-Friday,
Fixed Term Contract until April 2027
Salary: Competitive (dependent on experience)
+ Benefits (Private healthcare, Contributory pension, health and a vast range of rewards you would associate with a leading private healthcare organisation)
As a Clinical Trial Set Up Specialist, you will
coordinate set up activities for new studies and liaise with external stakeholders to ensure study activation timelines are met. You will manage the coordination and completion of essential trial documentation from set up to study activation for SCRI UK's Oncology Drug Development Unit (DDU) including budget and contract negotiations.

Duties Include But Are Not Limited To

• Manage individual portfolio of external Sponsors and organise regular engagement with Sponsors to discuss pipeline and gain interest in new studies.
• Plan and coordinate pre-selection (PSV) and site initiation visits (SIV).
• Liaise with internal stakeholders to coordinate set up of new studies, including Clinical, Business Operations and Invoicing teams.
• Create and complete the negotiation of the study budget and contract before study activation.
• Use of site Clinical Trial Management System (CTMS) for the purpose of study finance budgeting and tracking of setup document completion.
• Liaise with trial sponsor's to ensure full external regulatory approvals, including Health Authority and Ethics Committee, are received before study activation.
• Ensure the delivery of equipment, investigator site files and other required study supplies prior to site activation.
• Submission to Local R&D and RRC for internal approval of new studies.
• Ensure the completion and hand over of essential documents for the Investigator Site Files (ISFs) to the Trial Coordinator for study activation.
• Ensure compliance with ICH-GCP.

Skills & Experience

• Previous experience in clinical research is essential
• Oncology clinical trial experience is desirable
• Clinical Trial Setup or Coordination experience is desirable
• Extremely competent in Microsoft Excel application
• Recent Good Clinical Practice (GCP) training
• Knowledge or experience with contract negotiation processes is desirable
• Educated to a degree level within sciences or related field (advanced degree desirable i.e. MSc, PhD)
• Excellent communication skills

Why HCA UK?
Originally founded over 50 years ago by Dr Thomas Frist, HCA has gone on to become one of the world's leading healthcare providers. In the UK, we're one of the largest providers of privately funded healthcare and have invested over £500 million in the latest treatments, technology, techniques, medication and facilities. Being part of a large multisite, established healthcare group we can offer you unrivalled opportunities for career progression through internal and external courses, as well as working conditions that prioritise both your mental and physical wellbeing.

Benefits
By caring for our employees, we empower them to provide exceptional care for our patients. That's why we offer a host of flexible benefits that reflect the invaluable contribution they make every day. You'll be eligible for:

• 25 days holiday each year (plus bank holidays) increasing with service, with option to buy or sell leave to suit you
• Private Healthcare Insurance for treatment at our leading hospitals
• Private pension contribution which increases with length of service
• Season Ticket Loan and Cycle to Work scheme
• Group Life Assurance from day one
• Critical illness cover
• Enhanced Maternity and Paternity pay
• Corporate staff discount for all facilities including Maternity packages at The Portland
• Comprehensive range of flexible health, protection and lifestyle benefits to suit you
• Discounts with over 800 major retailers

Culture and values
At HCA UK we believe exceptional care starts with our people. We celebrate the unique perspectives and different experiences each of us bring as we know that when you feel seen, heard and supported you can be at your best for our patients, and each other.

Our Mission Is Simple, Above All Else We're Committed To The Care And Improvement Of Human Life, a Clear Statement That Extends To Both Our Patients And Colleagues. To Achieve This, We Live And Breathe Four Core Values

• Unique and Individual: We recognise and value everyone as unique and individual
• Kindness and compassion: We treat people with kindness and compassion
• Honesty, integrity and fairness: - We act with absolute honesty, integrity and fairness
• Loyalty, respect and dignity: We trust and treat one another as valued members of the HCA UK family with loyalty, respect and dignity

Reasonable adjustments
We believe everyone should feel comfortable to bring their full self to work and be afforded the same opportunities. As a Disability Confident committed organisation, we're happy to discuss flexible working arrangements to suit your needs as well as offer reasonable adjustments throughout our recruitment process, and in the workplace, to anyone that needs them.