Clinical Trial Associate I

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 I (CTA I) 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 I’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.
• Drafts and/or reviews study-related documents and templates including study protocols, informed consents, source document templates, study plans, study-related logs, etc.
• Participate in study start-up (including Investigator Meeting), study maintenance, and study closeout activities.
• Collect and review site regulatory documents for accuracy and completion (e.g., 1572, Financial Disclosure documents, CLIA waivers, etc.).
• Prepare, with oversight, essential documents package to support investigational product release for study and site approval.
• Create regulatory packages for IRB/IEC submission for study and site initial submission as well as applicable study and site continuity report submissions and close-out submissions.
• Assemble and distribute regulatory binders to clinical sites.
• Order and ship study-related supplies to clinical sites.
• Create Site Payments, obtain approval, and submit to Accounting.
• Support Clinical Research Associates during monitoring visits to help ensure that any missing documents are filed within the eTMF and the site binder.
• Support project management activities including but not limited to drafting meeting agendas/minutes, drafting communication, and maintaining CTMS and the study tracker(s).
• Assist project managers in preparing study metric reports and collecting site status updates.
• Set-up and maintain the Trial Master File / electronic Trial Master File, and using applicable file-sharing platforms (i.e., Z:drive, box.com) for clinical projects.
• Address Quality Control findings resulting from internal and external Trial Master File audits.
• Participate in Study Operations planning, Risk Assessment discussions, and Pre-Study Meetings.
• Provide support to Clinical Operations for implementing process improvement actions, remaining current on all relevant and applicable SOPs, and participating in departmental training sessions.
• Assist with audit preparations (i.e., Sponsor, IRB/IEC, FDA).
• Travel Requirements: up to 10%.
• 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 from the above based on the specific needs of the business.

What We Look For:

• Experience needed for the Role:
  • Bachelor’s Degree with a minimum of 1-year experience of research, including coursework. Years of experience may be considered in lieu of education.
• Additional Skills & Attributes:
  • 1 year of clinical trial experience is strongly preferred.
  • Ophthalmic experience
  • Ability to work 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.
  • Committed to consistently producing high-quality work.
  • Exceptional organizational and time management skills in order to manage multiple trials, critical tasks, and departmental process improvement efforts.
  • Multilingual communication is a plus.