Clinical Trial Associate II

🔥 15 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Ora

WebsiteLinkedInAll Job Openings

201 - 500 employees

🏭 Manufacturing

💼 Consulting

📦 Logistics

Manufacturing • Consulting • Logistics

Ora is the world's leading full-service ophthalmic drug and device development firm with offices in the United States, United Kingdom, Australia, and Asia. For over 45 years, Ora has helped clients earn more than 85 product approvals, supporting a wide array of organizations from start-ups to global pharmaceutical and device companies. Their offerings include pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies, all refined through thousands of global projects. Ora boasts an extensive and experienced team of ophthalmic experts, R&D professionals, and management executives to maximize the value of new product initiatives.

📋 Description

• Assist Project Managers and study teams with clinical study conduct for ophthalmic projects • Support study feasibility, site contracts and budgets, regulatory document collection, follow-up patient visit scheduling, and GCP protocol compliance • Ensure study documentation, communication, training, and data collection align with protocols, SOPs, regulations, and guidelines • Lead development of study-related documents, including informed consent forms, source documents, and study logs • Participate in clinical trial site management from study start-up through study conduct and closeout • Collect and review site regulatory documents for accuracy and completeness • Prepare essential document packages for investigational product release, site approval, continuity reports, and closeout submissions • Create regulatory packages for IRB/IEC study and site submissions • Assemble and distribute regulatory binders and provide Investigator Site File trackers for monitoring visits • Support project management through meeting minutes, agendas, weekly newsletters, and clinical study tracking systems • Assist with study reports, site status updates, and study metrics • Set up, maintain, and quality-control Trial Master Files/electronic Trial Master Files and file-sharing platforms • Participate in Study Operations planning, risk assessment discussions, and pre-study meetings • Support process improvement, SOP reviews, and departmental training • Assist with audit preparation and responses to audit findings • Adhere to Ora's quality system, data integrity, business ethics, and regulatory requirements

🎯 Requirements

• Bachelor's degree and a minimum of 1 year of experience as a clinical trials associate; years of experience may be considered in lieu of degree • Ophthalmic experience strongly preferred • Ability to work independently and in a semi-virtual, cross-functional team environment • Analytical and problem-solving skills • Consistent sense of urgency and acute attention to detail • Knowledge of GCP/ICH regulations • Experience maintaining electronic trial master files • Excellent verbal and written communication skills • Exceptional organizational and time management skills to manage multiple trials, critical tasks, and process improvement efforts • Ability to remotely problem-solve with site staff • Travel requirements less than 10%

🏖️ Benefits

• Comprehensive Medical, Dental and Vision healthcare options beginning day 1 • Flexible PTO • Unlimited sick time • 14 company paid holidays • 401K plan through Fidelity with company match • Adoption and fertility assistance • 16 weeks paid parental leave • Company-paid life insurance • Company-paid disability insurance • Remote workspace reimbursement • Wellness reimbursement • Employee Assistance Program • Career development opportunities • Opportunities to work with colleagues across the globe • Opportunity to research new ophthalmic therapies impacting patients globally