Clinical Trial Associate

1 week ago

Oxford, United Kingdom kps life Full time

KPS Life is looking to hire a Senior CTA to join one of our embedded client teams - office based role Oxford Area. 1 year contract, full FTE.Main Purpose of the RoleThe Senior Clinical Trial Assistant supports the Clinical Operations team in planning, executing, and managing clinical trials and programs. This role collaborates closely with Clinical Project Managers (CPM), Clinical Trial Managers (CTM), CRO representatives, vendors, and other internal departments to ensure compliance, efficiency, and inspection readiness.Key ResponsibilitiesReview site contracts, budgets, and confidentiality agreements (CDAs).Evaluate and approve regulatory documents for IRB/EC submissions and investigational product release.Provide oversight and accountability for third-party vendors.Ensure Trial Master File (TMF) inspection readiness:Assist in creating TMF Index and TMF Plan.Conduct periodic TMF reviews for completeness and accuracy.Support document filing, naming conventions, and archiving.Coordinate meetings, prepare agendas, and draft minutes.Track milestones, generate study metrics, and report updates to management.Liaise with CPM and other stakeholders to resolve study-related issues.Post trial information on public registries (e.g., ClinicalTrials.gov).Ensure compliance with GCP/ICH guidelines and company SOPs.Assist in publishing clinical trial documents (protocols, amendments, investigator brochures, lab manuals).Prepare and distribute site and internal supportive documents.Create purchase orders for vendors as needed.Contribute to SOP and work instruction development.Identify and communicate issues impacting budget, resources, and timelines.EssentialEducation & ExperienceDegree in biological sciences, pharmacy, or related health discipline.Minimum 5 years of clinical operations experience in biotech/pharma or CRO.Experience with global/international studies.Strong knowledge of GCP principles and early-phase trials.Proficiency in Microsoft Office and ability to learn IRT and EDC systems.Proven track record in supporting clinical study projects.PreferredOncology therapeutic experience.Familiarity with eTMF systems.Ability to manage multiple trials/programs.#kpslife#LI-onsite

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    Oxford, United Kingdom kps life Full time

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    Oxford, United Kingdom kps life Full time

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    3 days ago

    Oxford, Oxfordshire, United Kingdom kps life Full time

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