[Hiring] Clinical Trial Associate I @Ora

Role Description

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
• Scheduling follow-up patient visits of all clinical sites
• Ensuring 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
• Draft and/or review 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 relative 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 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 -- prioritizing kindness, operational excellence, cultivating joy, and scientific rigor
• Responsibilities may differ from the above based on the specific needs of the business

Qualifications

• Bachelor’s Degree with a minimum of 1-year experience of research, including coursework. Years of experience may be considered in lieu of education
• 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

Benefits

• Inclusive and supportive work environment
• Respect, accountability, and a fulfilling work-life balance for every team member