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Clinical Research Coordinator I

4 months ago

Newport Beach, United States Ora Full time
Job DescriptionJob Description

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 * Scientific Rigor

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 pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects. Today, our team continues to expand across the globe, with over 600 employees across North America, Europe, Asia, and Latin America.

The Role:

Ora's Clinical Research Coordinator I (CRC) has close relationships with the subjects who participate in our clinical trials located regionally, domestically, and at times, internationally. You will travel with a team of like-minded individuals to clinical sites assigned to conduct world-class research using proprietary methodologies and prepare the site for success. Once onsite, our CRCs collect, record, and organize research information for clinical projects, while ensuring compliance with clinical project protocol and overall clinical objectives. Our CRCs partner with Clinical Research Coordinator IIs, Lead Clinical Research Coordinators (LCRC), and Clinical Project Managers (CPM) to execute protocol directives and work cross-functionally with internal and external teams such as other Research Coordinators and Investigators. This position will report to a LCRC.

What You'll Do:

  • Fulfill initial and continued training prior to performing tasks in clinic setting.
  • Coordinate travel accommodations including hotel reservations, rental cars, and flights as needed in accordance with Ora's Travel & Expense Policy.
  • Perform trained clinical skills per protocol at and as delegated by site Principal Investigators study visits in accordance with Ora SOPs, WKIs, practicums, and GCPs/GDPs.
  • Maintain protocol compliance during study conduct.
  • Be compliant with SOP, ICH-GCP, OSHA, HIPAA, and other regulations as applicable.
  • Participate in study start-up activities such as putting together charts, pulling patient charts, and ensuring site cleanliness.
  • Perform patient screening, recruitment, and enrollment.
  • Maintain study documents, including source documentation, case report forms, and regulatory documentation.
  • Enter data into database and resolve data queries.
  • Exhibit business acumen and professional etiquette in all aspects of clinic and staff operations including adherence to company dress code.
  • Log time and expenses according to the guidelines of the company expense policy; properly indicating expense category and study allocation with accuracy.
  • Clear and sustained demonstration of Ora Clinical's Values of prioritizing kindness, operational excellence, cultivating joy, and scientific rigor.
  • Be willing to 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 (at completion of training).
  • 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.
  • Clear and sustained demonstration of Ora's values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors.
  • Responsibilities may differ from the above based on the specific needs of the business.

What We Look For:

  • Experience Needed for Role:
    • Bachelor's degree in Life Sciences or 1-year experience in a clinical or lab setting including course work.
  • Additional Skills and Attributes:
    • Previous experience as a research coordinator strongly preferred.
    • Certified Ophthalmic Associate or Certified Ophthalmic Technician certifications strongly preferred.
    • Advanced degree in related study preferred but not required.
    • Medical skills and/or certifications such as (CPT) certified phlebotomist technician, (EMT) Emergency Medical Technician preferred.
    • The ability to work a flexible schedule including weekends.
    • A team player attitude with a strong interest in clinical studies and enjoy interacting with patients.
  • Competencies and Personal Traits:
    • What We Do:
      • Execution Excellence: Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work.
    • How We Do It:
      • IQ, EQ and SQ: Agile and positive thinker, communicator and collaborator who uses a growth mindset to work and lead with authenticity, transparency, resilience, and empathy. Scientific, intellectual, and emotional/social curiosity creates the willingness and ability to innovate, make mistakes, learn and try again.
      • Clear and Direct Communication, Feedback and Conflict Resolution: Practice radical candor in your communication and participate in active Giving and receiving feedback frequently, with an open heart and mind creates psychological safety and promotes faster, individual, team and company growth.
    • Why We Do It:
      • 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. At Ora, we are creating vision beyond what we see.

What We Offer

  • Well-Being: Offering comprehensive healthcare options in Medical, Dental, and Vision beginning day 1.
  • Flexible PTO & Unlimited Sick Time:Providing you the freedom to unwind and recharge when you need to in addition to 14 company-paid holidays.
  • Financial: Competitive salaries along with a 401K plan through Fidelity with company match.
  • Family Support Care: Adoption and fertility assistance provided along with offering 16 weeks paid Parental Leave.
  • Company Paid Life & Disability Insurance: Offering peace of mind to help you and your family feel secure.
  • Remote & Wellness Reimbursement: We'll reimburse you to support your remote workspace and wellness purchases.
  • Employee Assistance Program: No matter what issues you're facing, New Directions is here to help you and your family.
  • Career Development Opportunities: Continued opportunities to grow and develop your career journey.
  • Global Team: Opportunities to work with colleagues across the globe.
  • Impact: A chance to research new ophthalmic therapies that will impact patients across the globe.

Benefit Eligibility: Full-time employees of Ora working a minimum of 30 hours per week. Our per diem workforce is eligible for Medical and Dental coverage once they have hit 6 months of service and work an average of 30 hours per week.

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.

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