Clinical Trials and Research Start Up Specialist

Description

Job Title: Clinical Trials and Research Start Up Specialist Department: Beacon Hospital Research Institute Reports to: Director PSQI Date: 2026 Hours per week - 37 hours per week Full time, permanent Overall Purpose of Job We will provide exceptional patient care in an environment where quality, respect, caring and compassion are at the centre of all we do. The Clinical Trials & Research Start-Up Specialist will provide dedicated coordination of the set-up and activation of clinical trials and research studies within Beacon Hospital Research Institute (BHRI). The portfolio of Clinical Trials and Research studies ranges from Sponsored Interventional trials to investigator led academic research studies. The primary focus of the role is to support and progress new studies from initial enquiry and feasibility through governance, ethics, contracts, budgets and operational readiness to site activation. The post holder will act as the central coordination point between Principal Investigators, sponsors, BHRI and relevant Beacon Hospital departments. The role will ensure that start-up requirements are identified, assigned, tracked and completed in a proactive, timely, compliant and organized manner. Stakeholder collaboration is a central purpose of this position. The Start Up Specialist will work closely with Primary Investigators, Sponsors and the Clinical Research team during scoping and initiation phase. Once a study is activated, the specialist will complete a structured handover to the appropriate clinical trial delivery team and retain oversight only where significant start-up actions or amendments remain outstanding. Key Responsibilities and Deliverables Clinical Trial Pipeline and Feasibility · Coordinate new clinical trial and research enquiries received by BHRI and maintain oversight of the start-up pipeline. · Coordinate completion of sponsor and CRO feasibility questionnaires within agreed timelines. · Work with Principal Investigators and relevant hospital departments to assess site capability, patient population, resources and operational requirements. · Coordinate feasibility input from Pharmacy, Radiology, Pathology, Nursing, Finance, Information Technology and other supporting departments, as required. · Identify potential barriers to activation at an early stage and escalate material risks or unresolved dependencies. · Maintain clear status visibility for studies under consideration, in feasibility, selected for Beacon, in contracting, awaiting approval, preparing for activation or ready to open. · Submit regular start-up pipeline status reports to Beacon Hospital Clinical Governance and BHRI steering board. Study Start-Up Coordination · Develop and maintain a start-up plan for each proposed study, including milestones, owners, dependencies and target dates. · Coordinate all activities required to progress a study from site selection to activation. · Maintain start-up trackers and proactively follow up outstanding actions with internal and external stakeholders. · Coordinate agreement documents, investigator and site documentation, sponsor qualification activities and site-selection visits. · Coordinate site initiation and activation meetings and ensure agreed actions are completed. · Confirm that all required start-up conditions have been met before the study is released for activation. · Complete a structured handover of activated trials to the relevant clinical trial delivery team. Ethics, Regulatory and Governance Coordination · Coordinate preparation and submission of study documentation through applicable ethics, regulatory and Beacon Hospital governance pathways. · Coordinate and maintain oversight of submission status, approvals, queries and outstanding documentation. · Coordinate responses to requests for clarification or further information from relevant reviewing bodies. · Maintain accurate, current and inspection-ready records of approvals and essential regulatory documentation. · Confirm that applicable approvals are in place before study activation. · Work closely with BHRI colleagues responsible for regulatory compliance, data protection and research governance. Contracts, Budgets and Financial Set-Up · Coordinate the operational progression of Clinical Trial Agreements and associated study agreements. · Liaise with sponsors, researchers and relevant Beacon stakeholders to support timely contract review and approval. · Coordinate development and review of study budgets and site costs. · Ensure that departmental, service and pass-through costs are identified during feasibility and start-up. · Track contract and budget approval as critical activation milestones and escalate delays or unresolved issues. Operational Readiness · Coordinate multidisciplinary readiness across the Principal Investigator and clinical team, Clinical Trials Unit, Pharmacy, Radiology, Pathology/Laboratory, Nursing, Finance, Information Technology, data protection, information governance and other departments required by the protocol. · Confirm that study-specific workflows, training, access, equipment, supplies, documentation and service arrangements are in place before activation. · Coordinate operational readiness meetings where cross-departmental planning is required. · Maintain documented evidence of readiness and outstanding actions. Essential Documents and Site Files · Coordinate collection and maintenance of study start-up documentation. · Establish the Investigator Site File and associated essential-document structure before activation. · Maintain document completeness, version control and filing standards. · Coordinate collection of CVs, Good Clinical Practice certificates, training records, delegation evidence and other investigator or site credentials. · Ensure that start-up documentation is complete and transferred appropriately to the study team at handover. Person Specification Qualifications · Degree in Life Sciences, Health Sciences, Nursing, Pharmacy, Biomedical Science, Business/Healthcare Administration or a related discipline. · Current Good Clinical Practice training, or a commitment to complete required training on appointment. · A postgraduate qualification or recognised clinical research certification is desirable. Experience · Relevant experience in clinical trials, clinical research, healthcare research administration or another regulated environment. · Experience coordinating multiple workstreams, stakeholders, documents and deadlines. · Previous experience in clinical trial feasibility, start-up or site activation is highly desirable. · Experience within an acute hospital, clinical trials unit, CRO, pharmaceutical company or medical-device organisation is desirable. · Experience supporting ethics or regulatory submissions, contracts, budgets or multidisciplinary operational readiness is desirable. Job Specific Competencies and Knowledge · Good understanding of the clinical trial start-up lifecycle, from enquiry and feasibility to site activation. · Knowledge of Good Clinical Practice and research governance requirements. · Working knowledge of relevant Irish and EU clinical trial, ethics, data protection and institutional requirements. · Ability to interpret study protocols, schedules of assessment and sponsor start-up requirements. · Strong project coordination, document control, action tracking and risk-escalation capability. · Ability to work credibly with senior clinicians, sponsors and multidisciplinary hospital departments. · High level of proficiency in Microsoft Office and experience using electronic tracking or clinical trial systems. Personal Competencies · Highly organised, proactive and delivery focused. · Exceptional attention to detail and commitment to accurate documentation. · Clear, responsive and professional communicator. · Collaborative and able to build effective relationships across clinical, corporate and external teams. · Confident in identifying barriers, escalating risks and progressing issues to resolution. · Adaptable, solution focused and comfortable working in an evolving service. · Committed to patient safety, research integrity, confidentiality and continuous improvement. Key Performance Indicators · Turnaround time from initial feasibility request to completed feasibility response. · Time from site selection to site activation. · Percentage of start-up milestones completed within agreed timelines. · Number and status of studies progressing through the BHRI start-up pipeline. · Number of new studies successfully activated. · Percentage of studies with required contracts, budgets, approvals and operational readiness completed before activation. · Completeness of essential documentation at activation and handover. · Volume, cause and ageing of outstanding start-up dependencies or delays. · Sponsor, CRO and internal stakeholder feedback on responsiveness and start-up coordination. · Demonstrable process improvements that reduce avoidable start-up delays. General Requirements All posts in Beacon Hospital require a high level of flexibility to ensure the delivery of an effective and efficient service. The post holder will therefore be required to demonstrate flexibility as and when required by their manager or Hospital management. The post holder must comply with Beacon Hospital policies and procedures relating to confidentiality, data protection, information governance, health and safety, research governance, professional conduct and quality management. This job description is intended to outline the areas of responsibility and deliverables at the time of writing. As the Hospital, BHRI and the post holder develop, the job description may be reviewed in light of changing service needs.