Clinical Research Associate – Contract

🕒 il y a 21 jours

🍂 Massachusetts – Distant

🍂 Massachusetts – Remote

⏳ Contrat

🟢 Junior

🟡 Intermédiaire

🧪 Chercheur Clinique

👻 Score fantôme 12%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Lumicell

Site WebLinkedInTous les Emplois

51 - 200 employés

🏭 Fabrication

🏥 Santé

🧬 Biotechnologie

💰 €28 700 000 Series C en 2017-10

Manufacturing • Healthcare • Biotechnology

Lumicell est une entreprise privée axée sur des technologies innovantes de fluorescence guidée pour la chirurgie du cancer, avec le potentiel d'améliorer les résultats pour les patients et de réduire les coûts de santé. Le premier produit de l'entreprise est le Système de Visualisation Directe Lumicell, conçu pour fournir une illumination en temps réel des tissus cancéreux dans la cavité mammaire lors de la tumorectomie initiale, pouvant potentiellement réduire les chirurgies répétées. L'agent d'imagerie optique propriétaire de Lumicell, applicable à tous les types de cancer, est également exploré pour une grande variété d'indications de tumeurs solides. La société vise à améliorer le traitement standard en guidant la résection de cancers supplémentaires qui auraient pu autrement être laissés en place.

Description

• Lead site start-up activities for post-market observational studies, registries, and related real-world evidence initiatives. • Manage site feasibility, qualification, readiness assessment, and activation workflows. • Coordinate collection, review, tracking, and follow-up of essential regulatory and start-up documents. • Support negotiation and execution tracking for Clinical Trial Agreements, Statements of Work, budgets, purchase orders, and related site documentation. • Coordinate site onboarding, including investigator and study staff training, access to study systems, and readiness for first subject enrollment. • Conduct and document Site Initiation Visits (SIVs), including review of protocol requirements, safety reporting expectations, EDC entry, product handling, and study workflow. • Confirm site access to EDC systems, study portals, imaging repositories, training platforms, and other study technologies. • Track site start-up milestones, identify activation risks or delays, and escalate barriers with recommended solutions. • Collaborate with Clinical Operations, Data Management, Regulatory Affairs, Quality, Pharmacovigilance, and external vendors to support timely site activation. • Conduct remote and on-site monitoring visits, including initiation, routine monitoring, and closeout visits. • Perform risk-based monitoring activities to support protocol compliance, subject safety, data quality, and regulatory compliance. • Review study data for completeness, consistency, and source-document alignment, as applicable to the study design. • Issue, track, and facilitate resolution of site queries in collaboration with Data Management and study teams. • Monitor site performance metrics, enrollment progress, data entry timeliness, protocol adherence, and follow-up completion. • Identify site risks and support corrective and preventive actions when needed. • Build productive relationships with investigators, research coordinators, operating room staff, and other site personnel. • Provide timely guidance, training, and support to sites throughout the study lifecycle. • Maintain accurate, complete, and inspection-ready monitoring documentation and site correspondence. • Support Trial Master File (TMF) quality, completeness, and essential document maintenance throughout the study lifecycle. • Document monitoring findings, action items, follow-up, and issue resolution in a timely and traceable manner. • Contribute to audit and inspection readiness activities.

🎯 Exigences

• Bachelor's degree in Life Sciences, Nursing, Public Health, Clinical Research, or a related field. • Minimum 3 years of CRA, Clinical Research Coordinator, or Clinical Operations experience. • Experience with site start-up, site activation, and site management activities. • Experience conducting monitoring visits, either remotely or on-site. • Working knowledge of GCP, ISO 14155, applicable FDA regulations, and clinical research documentation standards. • Experience using EDC systems, remote monitoring tools, and clinical trial document repositories. • Strong communication, organization, follow-up, and project management skills. • Ability to travel approximately 25–40%, based on study and site needs.

🏖️ Avantages

• Competitive salary • Remote work options • Professional development opportunities • Health insurance • Paid time off