Clinical Trial Associate II

at  ORA

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 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.
• Travel Requirements less than 10%
• 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
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• 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.