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Clinical Research Coordinator I

  2025-10-21     Ora     Newport Beach,CA  
Description:

Overview

POSITION TITLE: Clinical Research Coordinator I

DEPARTMENT: Anterior Segment

LOCATION: Newport Beach, CA

Ora values the daily practice of prioritizing kindness, operational excellence, cultivating joy, and scientific rigor. At Ora, we are building the future of ophthalmic clinical research. As the worlds 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. Ora has helped earn more than 85 new product approvals over the past 45 years and operates with over 600 employees globally.

The Role: Oras Clinical Research Coordinator I (CRC) has close relationships with subjects in regional, domestic, and occasionally international clinical trials. You will travel with a team to clinical sites to conduct world-class research using proprietary methodologies and prepare sites for success. Onsite, CRCs collect, record, and organize research information while ensuring compliance with the clinical project protocol and overall objectives. CRCs partner with other coordinators, Lead Clinical Research Coordinators, and Clinical Project Managers to execute protocol directives and work cross-functionally with internal and external teams. This position reports to a Lead Clinical Research Coordinator.

What Youll Do

  • Fulfill initial and continued training prior to performing tasks in a clinical setting.
  • Coordinate travel accommodations (hotel, rental cars, flights) as needed per Oras Travel & Expense Policy.
  • Perform trained clinical skills per protocol at visits as delegated by site Principal Investigators in alignment with Ora SOPs, WKIs, practicums, and GCPs/GDPs.
  • Maintain protocol compliance during study conduct.
  • Be compliant with SOPs, ICH-GCP, OSHA, HIPAA, and other applicable regulations.
  • Participate in study start-up activities (e.g., chart pulling and site setup).
  • Perform patient screening, recruitment, and enrollment.
  • Maintain study documents (source docs, case report forms, regulatory documentation).
  • Enter data into the database and resolve data queries.
  • Demonstrate business acumen and professional etiquette in clinic and staff operations, including adherence to dress code.
  • Log time and expenses according to company guidelines with accurate study allocation.
  • Demonstrate Ora Clinicals values (prioritizing kindness, operational excellence, cultivating joy, scientific rigor).
  • Travel domestically up to 90% of the time, including back-to-back trips and weekends if necessary.
  • Perform as Clinic Supervisor and Quality Control Technician at study visits (after training).
  • Adhere to Oras quality system and data integrity/regulatory requirements.
  • Support additional responsibilities as needed based on business requirements.

What We Look For

Experience Needed for Role:

  • Bachelors degree in Life Sciences or 1-year experience in a clinical or lab setting (including coursework).

Additional Skills and Attributes:

  • Previous experience as a research coordinator strongly preferred.
  • Certified Ophthalmic Associate or Certified Ophthalmic Technician strongly preferred.
  • Advanced degree in related study preferred but not required.
  • Medical skills and/or certifications such as CPT (phlebotomist) or EMT preferred.
  • Ability to work a flexible schedule including weekends.
  • Team player with strong interest in clinical studies and patient interaction.

Competencies and Personal Traits:

  • Execution Excellence: Ability to set goals, create structure, and maintain a focused, collaborative approach for timely, high-quality work.
  • IQ, EQ, and SQ: Growth-minded, communicative, collaborative, authentic, transparent, resilient, and empathetic; curious and willing to innovate and learn from mistakes.
  • Clear and Direct Communication, Feedback and Conflict Resolution: Practice candid communication and regularly give/receive feedback to promote growth and psychological safety.
  • Meaning and Purpose: Desire to be part of a team that makes a meaningful impact aligned with Oras values.

What We Offer

  • Well-Being: Comprehensive healthcare options (Medical, Dental, Vision) from day 1.
  • Flexible PTO & Unlimited Sick Time: In addition to 14 company-paid holidays.
  • Financial: Competitive salaries with a 401(k) plan and company match.
  • Family Support Care: Adoption and fertility assistance; 16 weeks paid parental leave.
  • Company Paid Life & Disability Insurance.
  • Remote & Wellness Reimbursement for remote workspace and wellness purchases.
  • Employee Assistance Program: Access to New Directions for support.
  • Career Development: Opportunities to grow and develop your career.
  • Global Team: Opportunities to collaborate with colleagues worldwide.
  • Impact: Opportunities to contribute to ophthalmic therapies that benefit patients globally.

Benefit Eligibility: Full-time employees of Ora working at least 30 hours per week. Per diem staff may be eligible for Medical and Dental after 6 months and 30 hours per week on average.

Our mission is to weave together people, processes, and technology to support innovation in ophthalmology. Oras values prioritizing kindness, cultivating joy, operational excellence, and scientific rigor guide our inclusive culture and work-life balance. Ora is an Affirmative Action and Equal Opportunity Employer. We encourage diverse applicants, including people of color, LGBTQIA+ individuals, people with disabilities, and veterans.


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