Clinical Trial Associate II

POSITION TITLE: Clinical Trial Associate II

DEPARTMENT: R&D

LOCATION: Hybrid in Andover MA

Ora values the daily practice of …

Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor

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The Role:

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 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 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 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.
  • Multi-lingual communication is a plus
• Attention to Detail: Ability to analyze available data and take the time to understand as full a picture as possible to drive successful solutions to complex problems.
• Emotionally Intelligent Leadership: Ability to lead with a positive mindset and empathy. Possess the capacity to understand others and to be aware of and sensitive to the feelings, thoughts, and experience of your colleagues and customers.
• Genuine Curiosity: Helpful in driving innovation at Ora by encouraging cross functional and inter-team information sharing through open dialog, discussion and active listening. Possessing an openness to question the status quo, leave space to "fail forward," and invest in thinking and exploration time for you and your team.
• Organization and Goal Setting: Ability to set goals, delegate appropriate tasks, and develop structure for yourself and your team to allow for successful multitasking and decision making.
• Resolve Conflicts: Practice radical candor in your communication with your team and colleagues as well as participating 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 then Yourself: Live a clear and sustained demonstration of the daily practice of Ora's Values of prioritizing kindness, operational excellence, cultivating joy and scientific rigor and the linked behavioral expectations.

Who We Are: The Ora Way: Flexible. Functional. Sustainable. Global.

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 forty years, our expert teams have helped earn more than fifty new product approvals. Today, our team continues to expand across the globe, with over 350 employees across the US, Europe, Australia, and Asia.

Our Mission and Vision

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.

Destination Workplaces

At Ora, we believe collaboration is the result of inspiration, not the catalyst for it. Destination workspaces are being introduced to provide immersive brand experiences that bring our culture, values, and vision to life. They will bring teams together for purposeful work and restorative connection with the natural world. Our first two locations, Moose Island in Eastport, Maine, and Waldingfield in Ipswich, Massachusetts, are currently under development with a focus on conservation and preservation of the environment. As a global company, we are also investing in ways to share inspiration with all — experiential teambuilding initiatives regardless of proximity to Ora owned properties.

Why Ora?

Constant innovation is a foundational tenet of Ora. The search for a better way. We are building a global, people-first work model for every Ora employee — regardless of role or location — that they can naturally embrace and succeed in; a model that anticipates professional needs, enables personal freedom, and rewards high levels of accountability and productivity. How we support our employees not only influences their personal experiences at Ora, it also determines who we are as a company. At Ora, you will have:

• Well-defined career paths with flexibility to learn different areas of the business
• Opportunities to work with international teams
• A chance to research new therapies that will impact patients across the globe
• The opportunity to have a significant impact on your team and the organization
• A receptive and adaptable community
• Access to collaborative and innovative-centered workspace
• Full time and per diem work opportunities

At Ora, 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.