Clinical Research Associate II

Clinical Research Associate II

Ora is seeking a dedicated Clinical Research Associate II (CRA II) to join our Monitoring department. This role focuses on building strong clinical site relationships and ensuring protocol performance and compliance. You will work under the oversight of Lead CRAs and your Line Manager.

About Ora

Ora is the world's leading full-service ophthalmic drug and device development firm, dedicated to building the future of ophthalmic clinical research. For over 45 years, our expert teams have helped bring new products and therapies to market, contributing to over 85 new product approvals. Our global team of over 600 employees across North America, Europe, Asia, and Latin America utilizes unique methodologies, integrated clinical data solutions, and global regulatory strategies refined over thousands of projects.

The Role and Responsibilities

As a Clinical Research Associate II, you will ensure Ora's compliance with study conduct by monitoring site activities against ICH/GCP, country regulations, Ora’s policies, and Sponsor SOPs. This involves cross-functional collaboration within Ora.

• Develop and maintain strong site relationships throughout all trial phases.
• Perform clinical study site management and monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, and Site Monitoring Plan.
• Gain a deep understanding of study protocols and related procedures.
• Coordinate and manage tasks with internal roles to achieve Site Readiness.
• Participate in and provide input on site selection and validation activities.
• Conduct remote and on-site monitoring and oversight to ensure data accuracy, integrity, and subject safety.
• Document all site visits (evaluation, initiation, monitoring, close-out) with clear, comprehensive, and accurate reports in a timely manner.
• Collect, review, and monitor required regulatory documentation for study start-up, maintenance, and close-out.
• Communicate effectively with Investigators and site staff regarding protocol conduct, recruitment, retention, deviations, regulatory documentation, and site performance.
• Identify, assess, and resolve site performance, quality, or compliance issues, escalating as appropriate.
• Manage and maintain information and documentation in CTMS, eTMF, and other systems per timelines.
• Support audit and inspection activities as needed.
• Adhere to Ora’s quality system, essential systems, and processes for data integrity, business ethics, and regulatory requirements.
• Demonstrate Ora’s core values: prioritizing kindness, operational excellence, cultivating joy, and scientific rigor.

What We Look For

• Bachelor’s degree with 2 years of experience as a Clinical Research Associate, or an equivalent combination of education, training, and experience.
• Ophthalmic experience is strongly preferred.
• Ability to routinely assess protocol and GCP compliance.
• Demonstrated ability to verify source data to reported data.
• Strong attention to detail for reviewing investigator site files.
• Knowledge of test article reconciliation and return/destruction procedures.
• Understanding of federal regulations governing research and Good Clinical Practices (GCPs).
• Ability to comprehend and adhere to clinical research protocols.
• Proficiency with Excel, CTMS, and EDC.
• Multilingual communication is a plus.

Competencies and Personal Traits

• Execution Excellence: Set goals, create structure, and maintain a focused and collaborative approach to deliver high-quality work on time.
• IQ, EQ, and SQ: Be an agile, positive thinker, communicator, and collaborator with a growth mindset, working with authenticity, transparency, resilience, and empathy. Demonstrate scientific, intellectual, and emotional/social curiosity to innovate and learn from mistakes.
• Clear and Direct Communication: Practice radical candor, actively give and receive feedback for faster growth and psychological safety.
• Seek Meaning and Purpose: Be part of a team that works under shared values to achieve significant positive impact in the world, contributing to 'vision beyond what we see'.

What We Offer

• Well-Being: Comprehensive healthcare options (Medical, Dental, Vision) starting day 1.
• Flexible PTO & Unlimited Sick Time: Freedom to unwind and recharge, plus 14 company-paid holidays.
• Financial: Competitive salaries and a 401K plan with company match.
• Family Support: Adoption/fertility assistance and 16 weeks of paid Parental Leave.
• Insurance: Company-paid Life & Disability Insurance.
• Remote & Wellness: Reimbursement for remote workspace and wellness purchases.
• Employee Assistance Program: Support for you and your family through New Directions.
• Career Development: Opportunities for continuous growth and career advancement.
• Global Team: Opportunities to collaborate with international colleagues.
• Impact: A chance to research new ophthalmic therapies impacting patients globally.

Benefit Eligibility

Full-time employees working a minimum of 30 hours per week are eligible. Per diem employees may be eligible for Medical and Dental after 6 months of service and averaging 30 hours per week.

Our Mission and Values

Our mission is to support innovation in ophthalmology worldwide by integrating people, processes, and technology. We believe business should be a force for good, improving and healing how we see. Our vibrant global community and culture are nurtured by our core values: Prioritizing kindness, cultivating joy, operational excellence, and scientific rigor. We foster an inclusive and supportive environment that promotes respect, accountability, and work-life balance.

Ora is committed to diversity and inclusion. We encourage applications from people of color, the LGBTQIA+ community, disabled candidates, and veterans. Ora is an Affirmative Action and Equal Opportunity Employer.

Key skills/competency

• Clinical Research Associate
• Ophthalmic Research
• GCP Compliance
• Protocol Management
• Site Monitoring
• Data Verification
• Regulatory Documentation
• CTMS
• EDC
• Investigator Communication