Job Title: Clinical Trial Set Up SpecialistLocation: Sarah Cannon Research Institute (Hybrid)Full Time 37.5 hrs/week. Monday-Friday, 0900-1700Fixed Term Contract until April 2027Salary: 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 ToManage 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 & ExperiencePrevious experience in clinical research is essentialOncology clinical trial experience is desirableClinical Trial Setup or Coordination experience is desirableExtremely competent in Microsoft Excel applicationRecent Good Clinical Practice (GCP) trainingKnowledge or experience with contract negotiation processes is desirableEducated to a degree level within sciences or related field (advanced degree desirable i.e. MSc, PhD)Excellent communication skillsWhy 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.BenefitsBy 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 youPrivate Healthcare Insurance for treatment at our leading hospitalsPrivate pension contribution which increases with length of serviceSeason Ticket Loan and Cycle to Work schemeGroup Life Assurance from day oneCritical illness coverEnhanced Maternity and Paternity payCorporate staff discount for all facilities including Maternity packages at The PortlandComprehensive range of flexible health, protection and lifestyle benefits to suit youDiscounts with over 800 major retailersCulture and valuesAt 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 ValuesUnique 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 dignityReasonable adjustmentsWe 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.
Job Title
Study Start-Up Specialist (Fixed Term)