Clinical Research Associate II

Job Description

Job Description

POSITION TITLE : Clinical Research Associate II

DEPARTMENT : Monitoring

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 Associate II (CRA II) develops strong clinical site relationships and is accountable for performance and compliance with assigned protocols at our sites.

Our CRA II's will work with the oversight of the Lead CRA's and Line Manager. As a CRA II, 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 :

• Responsibilities may differ slightly from the above based on specific needs of the business.
• Develop strong site relationships and ensures continuity of site relationships through all phases of the trial.
• Performs, with oversight, 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
• Conducts site visits including but not limited to evaluation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
• Collect, review, and monitor required regulatory documentation for study start-up, study maintenance and study close-out.
• Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits / inspections and overall site performance.
• Identify, assess and resolve site performance, quality or compliance problems and escalates as appropriate in collaboration with Clinical Research Lead and CRA line manager.
• Manage and maintain information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
• Supports audit / inspection activities as needed.
• 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.
• 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 with 2 years' experience as a Clinical Research Associate or equivalent combination of education, training, and experience.

Years of experience may be considered in lieu of education.

• Additional Skills & Attributes :
• Ophthalmic experience is strongly preferred.
• Capacity to routinely assess protocol and GCP compliance.
• Demonstrated ability to verify source data to reported data.
• Strong attention to detail to review the completeness of the investigator site file. Knowledge to reconcile and return / destroy test articles 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 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 :
• 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.

Our Privacy Policy Ora (oraclinical.com)