Clinical Research Associate I

At Ora, we are building the future of ophthalmic clinical research. As the world’s leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market. Over the past 45 years, our expert teams have helped earn more than 85 new product approvals.

Ora’s Clinical Research Associate I (CRA I) develop strong clinical site relationships and are accountable for performance and compliance for assigned protocols at our sites. Our CRA I’s will work with the oversight of the Lead CRA’s and Line Manager.

As a CRA I, you will ensure Ora’s compliance of study conduct by monitoring the site activities with ICH/GCP and country regulations, Ora’s policies, and Sponsor SOPs by partnering cross functionally within Ora.

What You’ll Do:

• Develop strong site relationships and ensures continuity of site relationships through all phases of the trial.
• Perform clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
• Gain in-depth understanding of the study protocol and related procedures.
• Coordinate & manage various tasks in collaboration with other internal roles to achieve Site Readiness.
• Participate & provide input on site selection and validation activities.
• Perform remote and on-site monitoring & oversight activities using various tools to ensure:

• Data generated at site are complete, accurate and unbiased
• Subjects’ right, safety and well-being are protected

Travel Requirements up to 75%. Adhere to all aspects of Ora’s quality system. Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora’s data integrity & business ethics and regulatory requirements.

What We Look For:

Experience Needed for the Role:

• Bachelor's degree with 1 years’ experience in the clinical research field or equivalent combination of education, training and experience.

Additional Skills and Attributes:

• Ophthalmic experience strongly preferred.
• Capacity to routinely assess protocol and GCP compliance.
• Demonstrated ability to verify source data to reported data.
• Strong attention to detail in order to review completeness of the investigator site file.
• Knowledge to reconcile and return/destroy test article while conducting initiation, interim, and close-out visits.
• Knowledge of the federal regulations governing research and the standards defining Good Clinical Practices (GCPs).
• Ability to read and demonstrate a comprehension of a clinical research protocol as well as understand the importance of following the protocol.
• Proficiency with Excel, CTMS and EDC.
• Multilingual communication is a plus.

Competencies and Personal Traits:

• Execution Excellence: Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work.
• Agile and positive thinker, communicator and collaborator who uses a growth mindset to work and lead with authenticity, transparency, resilience, and empathy.
• Clear and Direct Communication, Feedback and Conflict Resolution: Practice radical candor in your communication and participate in active giving and receiving feedback frequently.
• Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world.

What We Offer:

• Competitive salaries along with a structured pension plan.
• Offering private medical insurance healthcare beginning day 1 provided by Vitality and SimplyHealth.
• Company Paid Life & Disability Insurance: Offering peace of mind through Canada Life to help you and your family feel secure.
• 25 days of annual leave + Birthday PTO + bank holidays.
• Remote & Wellness Reimbursement: We'll reimburse you to support your remote workspace and wellness purchases.
• Continued opportunities to grow and develop your career journey.
• Opportunities to work with colleagues across the globe.
• A chance to research new ophthalmic therapies that will impact patients across the globe.

Our mission is to weave together people, processes, and technology to support innovation in ophthalmology around the world. We believe our business should be a force for good — to improve, heal, and change how we see. As a global company, our vibrant community and culture are nurtured by our core values: Prioritizing kindness, cultivating joy, operational excellence, and scientific rigor. Through our commitment to these values, we have built an inclusive and supportive work environment that fosters respect, accountability, and a fulfilling work-life balance for every team member.

We know a diverse workforce adds to our collective value and strength as an organization. People of color, the LGBTQIA+ community, disabled candidates and veterans are strongly encouraged to apply. Ora is proud to be an Affirmative Action and Equal Opportunity Employer, committed to equal employment opportunity and fair, equitable compensation regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.