Clinical Trial Associate II

Ora’s Clinical Trial Associate II (CTA II) assists Project Managers in clinical study conduct for clinical ophthalmic projects in posterior, anterior, and med device. They support the oversight feasibility including but not limited to, working with sites to generate contracts and budgets, collecting regulatory documents, and 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 in addition to performing additional day to day activities under the guidance of the Sr. CTA/Lead, Assistant Project Managers and Project Managers and liaise between field and office and are expected to work more autonomously and independently than the CTA I.

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 newsletter 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 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.
• Responsibilities may differ slightly from the above based on specific needs of the business.
• Clear and sustained demonstration of the Ora Clinical’s Values of prioritizing kindness, operational excellence, cultivating joy, and scientific rigor.
• 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 is 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:
  • Attention to Detail: Ability to analyze data to drive successful solutions to complex problems.
  • Emotionally Intelligent Leadership: Ability to lead with a positive mindset and empathy.
  • Intellectual Curiosity: Willingness and desire to learn new things and dig deeper than the surface.
  • Innovative Mindset: Forward thinking, creative, and open to testing, making mistakes, and trying again.
  • Organization and Goal Setting: Ability to set goals, develop structure, and maintain a focused approach to critical path work.
  • Resolve Conflicts: Practice radical candor in your communication and participate in active listening to help the other person feel heard and understood.
  • 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.

What We Offer:

• Financial: Competitive salaries along with a structured pension plan.
• Well-Being: Offering private medical insurance healthcare beginning day 1 provided by Vitality and SimplyHealth.
• Company Paid Life & Disability Insurance: Offering peace of mind through Canada Life to help you and your family feel secure.
• PTO: 25 days of annual leave + Birthday PTO + bank holidays.
• Remote & Wellness Reimbursement: We’ll reimburse you to support your remote workspace and wellness purchases.
• 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.

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.