Senior Clinical Research Associate

🕒 May 4

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 55%

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

• Develop strong clinical site relationships and maintain continuity throughout all trial phases • Perform clinical study site management and monitoring in compliance with ICH-GCP, Sponsor SOPs, local laws and regulations, protocols, and monitoring plans • Work under the oversight of the Lead CRA and Line Manager • Develop in-depth understanding of study protocols and related procedures • Coordinate tasks with internal roles to achieve site readiness • Participate in site selection and validation activities • Perform remote and on-site monitoring and oversight • Ensure site data are complete, accurate, and unbiased • Protect subjects’ rights, safety, and well-being • Conduct evaluation, initiation, monitoring, and close-out visits • Record clear, comprehensive, and accurate visit and non-visit contact reports • Collect, review, and monitor regulatory documentation for study start-up, maintenance, and close-out • Communicate with investigators and site staff regarding protocol conduct, recruitment, retention, deviations, documentation, audits, inspections, and site performance • Identify, assess, resolve, and appropriately escalate site performance, quality, and compliance issues • Maintain information and documentation in CTMS, eTMF, and other systems • Support audit and inspection activities • Adhere to Ora’s quality system, compliance processes, data integrity, business ethics, and regulatory requirements

🎯 Requirements

• Bachelor’s degree with 3 years’ experience as a Clinical Research Associate or equivalent combination of education, training and experience • Years of experience may be considered in lieu of education • Ophthalmic experience is strongly preferred • Capacity to routinely assess protocol and GCP compliance • Ability to assess an investigative site’s capabilities to conduct clinical research • Demonstrated ability to verify source data to reported data • Ability to monitor and report trial progress from start-up to completion • Knowledge of selecting and qualifying investigative sites • Strong attention to detail when reviewing investigator site files • Knowledge of reconciling and returning/destroying test articles during visits • Advanced knowledge of federal research regulations and Good Clinical Practices (GCPs) • Ability to comprehend and follow clinical research protocols • Proficiency with Excel, CTMS, and EDC • Multilingual communication is a plus • Travel requirements up to 75%

🏖️ Benefits

• Comprehensive medical, dental, and vision healthcare options beginning day 1 • Flexible PTO • Unlimited sick time • 14 company-paid holidays • 401(k) plan through Fidelity with company match • Adoption and fertility assistance • 16 weeks paid parental leave • Company-paid life and disability insurance • Remote workspace and wellness reimbursement • Employee Assistance Program • Career development opportunities • Opportunities to work with colleagues across the globe