About the job

About the RoleThe Clinical Trial Start-Up & Sample Management Co-Ordinator will support the successful set-up and delivery of clinical trials by coordinating study start-up activities, trial documentation, laboratory logistics, study product control and biological sample management. The role requires close collaboration with Science, Clinical Operations, Quality, Data Management, Project Management and external laboratory partners to ensure studies are conducted in accordance with ICH-GCP, protocol requirements and company SOPs. Training in these roles will be provided.

Key Responsibilities:

• Clinical Trial Start-UpCoordinate study start-up activities to ensure operational readiness.
• Prepare and maintain trial-specific documentation, including study plans, work instructions and study logs.
• Support ethics and regulatory submission readiness including protocol, participant information leaflet, informed consent etc. in collaboration with sponsor.
• Create and maintain study-specific folders.
• Prepare and maintain study product control documents including randomisation, labelling and QC in line with study requirements.
• Coordinate third-party vendor and laboratory set-up activities.
• Assist in the development and testing of study-specific tools and systems.
• Train study teams on protocol-specific procedures and study requirements.
• Attend/present at SIVs

• Sample Management & Laboratory OperationsManage the receipt, processing, storage, tracking and shipment of biological samples.
• Maintain accurate sample inventories, chain-of-custody records and freezer maps.
• Monitor sample storage conditions, investigate any temperature excursions and put preventive actions in place, and report activities to the Quality Manager.
• Ensure laboratory supplies and study materials are ordered and maintained.
• Liaise with sponsor and third-party laboratories regarding sample logistics and shipments.
• Support equipment maintenance, calibration and laboratory quality processes.
• Ensure all laboratory activities are conducted according to SOPs, safety requirements and study protocols.
• Recognise and report any issues or discrepancies with samples, processes, documentation or equipment.
• Ensure that all safety guidelines are always followed strictly and maintain a clean and orderly working environment.
• Train and supervise lab staff when required.
• Responsible for sample biohazard waste disposal for the lab.

• Study Close-OutCoordinate sample reconciliation, shipment and destruction activities.
• Ensure all sample accountability records are complete and accurate.
• Support study archiving, audits and close-out activities. 

Qualifications & Experience:

• EssentialExperience in Life Sciences, Biomedical Science, Nutrition, Microbiology or a related discipline.
• Experience in clinical research, laboratory operations or clinical trial coordination.
• General understanding of ICH-GCP and clinical trial processes.
• Excellent organisational, communication and documentation skills.
• High level of attention to detail and ability to manage multiple priorities.

• DesirableExperience working within a CRO, clinical research unit or regulated laboratory.
• Experience with sample management systems, EDC/eCRF platforms or laboratory quality systems.
• Knowledge of ethics submissions and regulatory requirements.

• Key CompetenciesOrganisation and planning
• Attention to detail
• Problem-solving
• Team collaboration
• Communication skills
• Quality and compliance focus
• Ability to work independently in a fast-paced environment

Salary Range:€40,000-€45,000 per annum.