Clinical Research Associate II

🕒 May 4

🇺🇸 United States – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 56%

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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 ensure continuity throughout all trial phases • Perform clinical study site management and monitoring under oversight • Monitor compliance with ICH-GCP, Sponsor SOPs, local laws and regulations, protocols, and site monitoring plans • Gain an 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 • Prepare 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, regulatory documentation, audits, inspections, and site performance • Identify, assess, resolve, and 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, data integrity, business ethics, and regulatory requirements

🎯 Requirements

• Bachelor’s degree with 2 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 • Capacity to routinely assess protocol and GCP compliance • Ability to verify source data to reported data • Strong attention to detail when reviewing investigator site files • Knowledge to reconcile and return/destroy test articles during initiation, interim, and close-out visits • Knowledge of federal regulations governing research and Good Clinical Practices (GCPs) • Ability to read and comprehend clinical research protocols and understand the importance of following them • Proficiency with Excel, CTMS, and EDC • Ophthalmic experience strongly preferred • Multilingual communication is a plus • Ability to travel 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

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