Clinical Trial Associate I

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🇪🇺 Europe – Remote

⏳ Contract/Temporary

🟢 Junior

🟡 Mid-level

👻 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 in conducting ophthalmic clinical studies • Support feasibility oversight, site contracts and budgets, regulatory document collection, and follow-up patient visit scheduling • Ensure study documentation, communication, training, and data collection comply with protocols, SOPs, regulations, and guidelines • Draft and review study-related documents and templates • Participate in study start-up, maintenance, and closeout activities, including Investigator Meetings • Collect and review site regulatory documents • Prepare essential document packages for investigational product release and site approval • Create IRB/IEC regulatory submission packages and continuity/closeout submissions • Assemble and distribute regulatory binders • Order and ship study supplies to clinical sites • Create, obtain approval for, and submit site payments to Accounting • Support Clinical Research Associates during monitoring visits and file missing documents in the eTMF and site binder • Support project management through meeting agendas/minutes, communications, CTMS, and study trackers • Assist with study metric reports and site status updates • Set up and maintain the Trial Master File/eTMF and file-sharing platforms • Address Quality Control findings from Trial Master File audits • Participate in Study Operations planning, risk assessments, and pre-study meetings • Support process improvement, SOP compliance, and departmental training • Assist with Sponsor, IRB/IEC, and FDA audit preparations • Adhere to Ora’s quality system, data integrity, business ethics, and regulatory requirements

🎯 Requirements

• Bachelor’s Degree with a minimum of 1-year experience of research, including course work; years of experience may be considered in lieu of education • 1 year of clinical trial experience is strongly preferred • Ophthalmic experience • Ability to work 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 • Multilingual communication is a plus • Ability to set goals, create structure, and maintain a focused and collaborative approach • Growth mindset, authenticity, transparency, resilience, empathy, and curiosity • Ability to practice clear and direct communication, feedback, and conflict resolution • Commitment to Ora’s values and mission

🏖️ Benefits

• Inclusive and supportive work environment • Fulfilling work-life balance • Equal employment opportunity and fair, equitable compensation • Up to 10% travel opportunity/requirement