Clinical Trial Associate I
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Job Description
Clinical Trial Associate supporting ophthalmic clinical studies at Ora, a full-service drug and device development firm. Managing regulatory documentation, trial master files, sites, and study operations.
Responsibilities:
- Assist Project Managers and study teams in conducting ophthalmic clinical studies
- Support feasibility oversight, site contracts and budgets, regulatory document collection, and follow-up patient visit scheduling
- Ensure study documentation, communication, training, and data collection comply with protocols, SOPs, regulations, and guidelines
- Draft and review study-related documents and templates
- Participate in study start-up, maintenance, and closeout activities, including Investigator Meetings
- Collect and review site regulatory documents
- Prepare essential document packages for investigational product release and site approval
- Create IRB/IEC regulatory submission packages and continuity/closeout submissions
- Assemble and distribute regulatory binders
- Order and ship study supplies to clinical sites
- Create, obtain approval for, and submit site payments to Accounting
- Support Clinical Research Associates during monitoring visits and file missing documents in the eTMF and site binder
- Support project management through meeting agendas/minutes, communications, CTMS, and study trackers
- Assist with study metric reports and site status updates
- Set up and maintain the Trial Master File/eTMF and file-sharing platforms
- Address Quality Control findings from Trial Master File audits
- Participate in Study Operations planning, risk assessments, and pre-study meetings
- Support process improvement, SOP compliance, and departmental training
- Assist with Sponsor, IRB/IEC, and FDA audit preparations
- Adhere to Ora’s quality system, data integrity, business ethics, and regulatory requirements
Requirements:
- Bachelor’s Degree with a minimum of 1-year experience of research, including course work; 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
- Analytical and problem-solving skills
- 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 to manage multiple trials, critical tasks, and process improvement efforts
- Multilingual communication is a plus
- Ability to set goals, create structure, and maintain a focused and collaborative approach
- Growth mindset, authenticity, transparency, resilience, empathy, and curiosity
- Ability to practice clear and direct communication, feedback, and conflict resolution
- Commitment to Ora’s values and mission
Benefits:
- Inclusive and supportive work environment
- Fulfilling work-life balance
- Equal employment opportunity and fair, equitable compensation
- Up to 10% travel opportunity/requirement
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