Job Description
Job Purpose
We are looking for a confident clinical study coordinator to join an established and high-performing study team. The role purpose is to deliver high-quality operational, data and participant-facing support for a commercial sponsor-led, large-scale observational clinical study. The post holder will act as a central operational and data quality resource, supporting participant queries, source data verification (SDV), data corrections, essential document management and NHS site coordination.
Key Responsibilities
•\tAct as a primary point of contact for participant queries on behalf of the commercial sponsor, ensuring responses are timely, accurate, protocol-compliant and participant-focused.
•\tPerform ongoing source data verification (SDV) activities in line with the sponsor’s monitoring plan, ensuring data accuracy, completeness and traceability between source records and EDC systems.
•\tRaise, manage and resolve data queries and perform sponsor-approved data corrections, ensuring appropriate documentation and audit trails are maintained.
•\tSupport the maintenance and quality oversight of the electronic Trial Master File (eTMF), ensuring sponsor and regulatory documentation is filed and remains inspection-ready.
•\tMaintain and support Investigator Site Files (eISFs) for NHS recruiting sites, proactively tracking essential documents, expiries and amendments in line with sponsor SOPs.
•\tCoordinate operational support for NHS recruitment sites, including site onboarding, document collection, approvals tracking and acting as a first-line contact for site queries.
•\tSupport study monitoring activities, including preparation for remote or on-site monitoring visits, responding to monitor findings, and supporting timely closure of follow-up actions.
•\tEscalate data quality or compliance issues, contributing to risk identification and mitigation activities.
•\tContribute to study metrics and reporting (e.g. data query status, SDV progress) as required.
•\tEnsure all activities are conducted in accordance with ICH-GCP, the UK Policy Framework for Health and Social Care Research, sponsor SOPs and contractual requirements.
•\tSupport audit and inspection readiness for sponsor-led audits or regulatory inspections, including MHRA inspections, where applicable.
•\tCapture minutes for funder meetings.
Essential criteria
•\tExperience working within clinical research, healthcare research administration or data-focused research roles/education.
•\tPractical experience handling data, including data entry, data checking, data entry or query resolution.
•\tClear understanding of data protection, and how it applies practically.
•\tDemonstrable high attention to detail and commitment to data accuracy and completeness.
•\tEffective communication skills with the ability to interact professionally with participants, NHS sites and external stakeholders.
•\tBasic working knowledge of ICH-GCP and clinical research governance, or willingness to undertake formal GCP training.
•\tAbility to prioritise workload across multiple sites or workstreams with minimal supervision.
•\tDemonstrates high levels of ownership and accountability.
Desirable Experience
•\tExperience working on large-scale or multi-centre observational studies.
•\tDemonstrable experience working on commercial clinical studies.
•\tExposure to commercial sponsor or CRO operations
•\tFamiliarity with NHS research approval pathways and site feasibility processes.
•\tExperience working with study metrics, KPIs or performance reporting.
•\tExperience performing SDV and data review activities in accordance with a monitoring plan.
Experience using electronic systems such as EDC platforms, document management systems or eTMF tools.
•\tExperience supporting monitoring visits, including responding to monitor queries and managing action items to resolution.
•\tConfidence working with NHS sites to proactively manage documentation, data quality and compliance issues.
•\tExperience contributing to inspection readiness or supporting audits.
Personal Attributes
•\tHighly organised with a meticulous and methodical approach to work.
•\tStrong sense of accountability and ownership for data quality, governance principles and and documentation.
•\tProactive and solution-oriented, with the confidence to escalate issues appropriately.
•\tProfessional, approachable and participant-focused.
•\tAbility to work collaboratively within sponsor, NHS site and study team environments.
WHO WE ARE:
Akrivia Health Limited has been established as a spin out company from the University of Oxford since 2019.
Akrivia Health’s primary purpose is to help to accelerate improvements in medical research, service delivery and health outcomes for patients with mental illnesses and dementia through the provision of advanced data analytics services and clinical trial optimisation support.
Package:
* Competitive salary package depending on skills and experience.
* Pension scheme with the opportunity to receive employer contributions.
* 25 days annual leave, plus the bank holidays (+3days after 3 years).
* Health insurance package after probation completion.
* Fantastic learning and development opportunities, including annual training budget.