Bcva Specialist

**POSITION TITLE**:BCVA Specialist

**DEPARTMENT**:Posterior Segment

**LOCATION**: Remote, Italy

**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**:
In clinical research trials where visual acuity is a primary endpoint, visual acuity testing is critical. Visual acuity testing (BCVA) must be done in a very specific way, following stringent guidelines and protocols. The gold standard for these guidelines was developed out of the landmark ETDRS study. The BCVA program at Ora works with therapeutic groups and trial Sponsors to develop, certify, and maintain the study specific testing parameters.

The BCVA Specialist-Europe will assist in all BCVA related activities. This begins with the BCVA procedures manual/protocol development and often direct communication with Sponsors. The work continues with specific testing design/ setup, communicating and working closely with study sites to set up certifications. Site BCVA certifications and maintenance is the primary focus and is necessary to ensure timelines are met and the integrity of BCVA data is maintained.

**What You'll Do**:

- Organize/file BCVA study specific materials including certifications, site and examiner evaluations, site information.
- Help to develop study specific procedures manuals and training materials.
- Order and/or manage inventory of study supplies.
- Assist in scheduling BCVA certifications (virtual and/or in person).
- Train and certify site staff and lanes to the study specific BCVA procedures.
- Frequent and timely communication with study teams and clinical sites.
- Attending study specific meetings as needed.
- Adhere to all aspects of Ora's quality systems.
- 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.
- Travel up to 75% or as business needs arise.
- Responsibilities may differ from the above based on the specific needs of the business.

**What We Look For**:

- _Experience needed for the Role: _
- Ophthalmic Assistant/ Technician/Optometrist (2+ years of practical experience)
- General experience and/or education in ophthalmology
- Experience in Clinical Research/ Clinical Trials
- Knowledge of the standards defining Good Clinical Practices (GCPs)
- _Additional Skills and Attributes:_
- Attention to detail and organization.
- Ability to work collaboratively with several teams and develop relationships with clinical sites.
- Ability to communicate effectively with others.
- Ability to travel up to 75% or as business needs arise.
- Multilingual communication is a plus.
- Experience with training.
- _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.

**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