In-house CRA
Advanced Clinical · France
Tailor my CV for this job — freeIn-house CRA – France
Location: Fully remote, anywhere in FranceEmployment type: PermanentModel: Dedicated FSPTravel: Up to 25%We are seeking an In-house Clinical Research Associate to join Advanced Clinical, working on a dedicated FSP basis with a global biopharmaceutical company.You will support CRAs and investigational sites across study start-up, trial conduct and close-out, combining remote site oversight with occasional site visits.Key responsibilitiesMaintain regular site contact to track recruitment, study supplies, data entry and outstanding actions.Review EDC remotely and follow up on data queries, including during database lock.Support CRAs with site visit preparation and follow-up, including action items and protocol deviations.Maintain study systems and perform quality checks of country- and site-level eTMF documentation.Support study start-up activities, including site documentation, contract negotiations and ethics submissions.Act as back-up for the primary CRA and support site audits and inspections.Conduct pre-study and close-out visits independently where approved, and co-monitor as required.Required experienceA degree in Life Sciences or a related discipline, or a Registered Nursing qualification.At least 2–3 years’ clinical research experience as a sponsor-side Clinical Trial Specialist, Clinical Trial Assistant or Site Coordinator.Strong knowledge of ICH-GCP, clinical trial processes and applicable regulatory requirements.Experience using EDC, IVRS/IRT and CTMS systems.Fluent written and spoken French and English.A valid driving licence and willingness to travel up to 25%.
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