Clinical Development Associate

🕒 Outubro 27

🐎 Kentucky, New Hampshire, +12 estados a mais – Remoto

🐎 Kentucky – Remote 🗻 New Hampshire – Remote 🏖️ New Jersey – Remote 🌶️ New Mexico – Remote 🗽 New York – Remote 🌲 North Carolina – Remote 🍂 Massachusetts – Remote 🎸 Mississippi – Remote 🔔 Pennsylvania – Remote 🌴 South Carolina – Remote 🗿 South Dakota – Remote 🤠 Texas – Remote ☕ Washington – Remote 🧀 Wisconsin – Remote

💵 $92.000 - $120.000 / ano

⏰ Tempo Integral

🟢 Júnior

🟡 Pleno

🚫👨‍🎓 Sem graduação necessária

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Esta empresa já patrocinou vistos H1B no passado.

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Aurion Biotech

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2022

🏥 Saúde

🏭 Manufatura

🧬 Biotecnologia

💰 $120.000.000 Venture Round - Aurion Biotechnologies em 2022-04

Healthcare • Manufacturing • Biotechnology

A Aurion Biotech é uma empresa em estágio clínico que desenvolve terapias celulares regenerativas pioneiras para restaurar a visão tratando doenças do endotélio corneano e outras causas de cegueira. A empresa se concentra em plataformas de terapia celular em escala de fabricação, utilizando células endoteliais corneanas de doadores humanos combinadas com compostos de apoio (por exemplo, inibidor de rho-quinase) para repovoar o endotélio corneano, reduzir a dependência de tecido doador e possibilitar alternativas menos invasivas à ceratoplastia baseada em enxertos. A Aurion realiza ensaios clínicos globais, possui designações de Terapia Inovadora e RMAT da FDA para seu principal produto AURN001 e visa expandir o acesso a cuidados oftalmológicos avançados em todo o mundo.

Descrição

• Support the clinical development team with scientific and medical oversight throughout study startup, enrollment, conduct, database lock, and study closeout • Support Medical Monitoring activities and patient cleaning activities, including medical monitor query management • Identify clinical risks and help develop mitigation strategies • Support development of study protocols, protocol amendments, informed consent documents, case report forms, and other clinical study documents • Help address protocol questions, eligibility determinations, deviations, and study conduct challenges • Ensure clinical studies comply with protocol requirements, ICH-GCP, applicable regulations, and Aurion SOPs • Partner with Biometrics and/or Data Management to develop data review plans and ensure data quality • Review clinical, efficacy, safety, imaging, and biomarker/pharmacokinetic data • Contribute to regulatory meeting preparation and interactions with global health authorities • Support briefing documents, responses to agency questions, and submission documents • Contribute scientific content for INDs, CTAs, annual reports, clinical study reports, and marketing applications • Collaborate with Clinical Operations, Medical Affairs, Regulatory Affairs, Biometrics, Pharmacovigilance, Quality Assurance, CRO partners, imaging centers, and other vendors • Support inspection readiness activities and participate in audits and regulatory inspections • Contribute to continuous process improvement initiatives within Clinical Development • Support a collaborative, high-performance culture aligned with Aurion Biotech’s mission and values

🎯 Requisitos

• Strong background in ophthalmology, ophthalmology clinical trials, and interpretation of ophthalmology data including visual acuity procedures and image collection • Bachelor’s degree in life sciences, nursing, or related field preferred • 1-3 years of experience in clinical research, including exposure to clinical trial operations, either in a sponsor, CRO, or academic setting supporting Phase 2 or 3 clinical trials • Familiarity with study start-up, site maintenance, closeout, and inspection readiness processes • Working knowledge of ICH/GCP guidelines and clinical trial processes • Strong organizational and time management skills; detail-oriented and able to manage multiple tasks • Proficient in Microsoft Office (Word, Excel, PowerPoint) • Experience with TMF, EDC, and other clinical trial systems a plus • Strong interpersonal and communication skills, both written and verbal • Ability to work effectively in a team environment and across global teams and vendors • Excellent written, verbal, and interpersonal communication skills; ability to communicate with impact across diverse internal and external stakeholders • Demonstrated cultural agility, integrity, and a passion for advancing transformative science • Ability to travel up to 15% • Strong alignment with, and commitment to, Aurion Biotech’s mission, vision, and core values

🏖️ Benefícios

• Full health insurance for employees and their families • 401(k) matching • EAP • FSA • Generous PTO • Paid parking • Subsidized commuter passes • In-office catered lunches • Team events • Community projects • Competitive compensation packages

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