Clinical Trial Associate II

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 400 employees across North America, Europe, Asia, and Latin America.

The Role:

Ora’s Clinical Trial Associate II (CTA II) assists Project Managers and study teams in clinical study conduct for clinical ophthalmic projects. They support the oversight feasibility including but not limited to, working with sites to generate contracts and budgets, collecting regulatory documents, and may be involved in scheduling follow-up patient visits of all clinical sites and ensures compliance with GCP protocol along with overall clinical objectives. Ora’s CTA II’s participate in all phases of clinical studies including start-up, study maintenance, and close-out activities.

What You’ll Do:

• Ensure study documentation, communication, training, and data collection is aligned with study protocol adherence, and all applicable SOPs, regulations, and guidelines
• Lead the development of assigned study-related documents (e.g., informed consent, source documents, study logs, etc.)
• Participate in all phases of clinical trial site management from study start-up, through study conduct, and completing closeout activities
• Collect and review site regulatory documents for accuracy and completion (1572, Financial Disclosure documents, CLIA waivers, etc.)
• Prepare essential documents package to support investigational product release for study and site approval as well as applicable study and site continuity report submissions and close-out submissions
• Create regulatory packages for IRB/IEC study and site submission, as well as applicable continuity report, and close-out submissions
• May assemble and distribute regulatory binders to clinical sites and provide monitors with Investigator Site File tracker in support of monitoring visits
• Support project management activities including providing meeting minutes/agendas and weekly newsletters to the clinical team, as well as maintaining the clinical study tracking systems
• Assist project managers in preparing study reports and collecting site status updates and study metrics
• Set-up and maintain the Trial Master File/electronic Trial Master File, and applicable filesharing platforms (i.e., Box.com, department server files) for clinical projects
• QC Trial Master File (for clinical projects where the individual is not setting up and maintaining the file)
• Participate in Study Operations planning, Risk Assessment discussions, and Pre-Study Meetings
• Provide support to Clinical Operations for implementing process improvement actions, performing bi-annual reviews of applicable SOPs, and conducting departmental training sessions
• Assist with Sponsor/IRB/IEC audit preparations and participate in response to audit findings
• Adhere to all aspects of Ora’s quality system
• Adhere to all essential systems and processes required at Ora to maintain compliance to Ora’s data integrity and 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 based on the specific needs of the business
• Travel Requirements: less than 10%

What We Look For:

• Experience needed for the Role:
  • Bachelor’s degree and a minimum of 1-year experience in clinical trials associate. Years of experience may be considered in lieu of degree
• Additional Skills & Attributes:
  • Ophthalmic experience strongly preferred
  • Ability to work both alone as well as in a semi-virtual, cross-functional team environment
  • Ability to apply analytical and problem-solving skills; ability to act with a consistent sense of urgency and acute attention to detail
  • Knowledge of GCP/ICH regulations
  • Experience maintaining electronic trial master files
  • Excellent verbal and written communication skills
  • Exceptional organizational and time management skills in order to manage multiple trials, critical tasks, and departmental process improvement efforts
  • Ability to remotely problem-solve with members of site staff
• 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, creating psychological safety and promoting 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.