Job Description

Job Description

Job Description

POSITION TITLE: Clinical Research Coordinator I

DEPARTMENT: Anterior Segment

LOCATION: Charlotte, NC

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 I) 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 other CRCs to clinical sites as assigned to conduct world-class research using proprietary methodologies. Once onsite, our CRC I's will administrate various technician-based tasks by collecting, recording, and organizing subject and research information during clinical research study visits while ensuring compliance with clinical project protocol and overall clinical objectives. Our CRC I's will partner with tenured Clinical Research Coordinators to execute protocol directives and work cross-functionally with internal and external teams such as other Research Coordinators and Investigators.

What You'll Do:

• Participate in a 3 week-long introductory onboarding (part virtual, part in person) to prepare to learn and demonstrate mastery in various introductory skill sets required to begin clinic work
• Travel to research sites as assigned for study visits to prepare for or continue clinical study conduct
• Participate in study start-up activities such as putting together charts, pulling patient charts, ensuring site cleanliness
• Contribute to and maintain study documents, including source documentation, case report forms, and regulatory documentation
• Perform various tasks (post-onboarding) such as use of proprietary technology, performing the Informed Consent process, documenting medical history and medications, taking vitals, scribing for medical staff, dispensing study drug, performing allergy skin tests, documenting controlled environment stats, and other ophthalmic assessments
• Prioritize and deliver an exceptional subject experience, putting subject safety and protocol adherence to the forefront of your work
• Collaborate with on-site staff, whether they be other Ora team members or clinic-based staff and Investigators
• Performs patient screening, recruitment, and enrollment
• Perform clinical skills identified in the SOP at study visits
• Participate in various parallel and compounding trainings to continue advancement of required clinic skills
• Maintain protocol compliance during clinical projects and adherence to work instructions and discretion in handling intellectual property
• Remain compliant and timely with SOP, ICH-GCP and regulations
• Enter and submit time sheets and expenses related to site travel in a timely manner, following the company expense policy.
• Prompt submission of work availability on a monthly basis
• Enter data into electronic database and resolves data queries
• Be willing to travel domestically up to 90% of the time including back-to-back trips and weekends, if necessary.
• 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 the Role:
  • Bachelor's degree in Life Sciences OR 1-year experience in a clinical setting
• Additional Skills & Attributes:
  • Previous experience as a research coordinator is strongly preferred
  • Certified Ophthalmic Associate or Certified Ophthalmic Technician certifications is strongly preferred
  • Medical skills and/or certifications such as (CPT) certified phlebotomist technician, (EMT) Emergency Medical Technician is preferred
  • This role requires a flexible schedule, including weekend availability, and the ability to travel domestically as needed
  • 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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