Clinical Trial Associate II
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Job Description
Clinical Trial Associate II supporting clinical trial operations for Ora's ophthalmic drug and device development programs. Managing regulatory documents, trial files, site activities, and study closeout.
Responsibilities:
- Assist Project Managers and study teams with clinical study conduct for ophthalmic projects
- Support study feasibility, site contracts and budgets, regulatory document collection, follow-up patient visit scheduling, and GCP protocol compliance
- Ensure study documentation, communication, training, and data collection align with protocols, SOPs, regulations, and guidelines
- Lead development of study-related documents, including informed consent forms, source documents, and study logs
- Participate in clinical trial site management from study start-up through study conduct and closeout
- Collect and review site regulatory documents for accuracy and completeness
- Prepare essential document packages for investigational product release, site approval, continuity reports, and closeout submissions
- Create regulatory packages for IRB/IEC study and site submissions
- Assemble and distribute regulatory binders and provide Investigator Site File trackers for monitoring visits
- Support project management through meeting minutes, agendas, weekly newsletters, and clinical study tracking systems
- Assist with study reports, site status updates, and study metrics
- Set up, maintain, and quality-control Trial Master Files/electronic Trial Master Files and file-sharing platforms
- Participate in Study Operations planning, risk assessment discussions, and pre-study meetings
- Support process improvement, SOP reviews, and departmental training
- Assist with audit preparation and responses to audit findings
- Adhere to Ora's quality system, data integrity, business ethics, and regulatory requirements
Requirements:
- Bachelor's degree and a minimum of 1 year of experience as a clinical trials associate; years of experience may be considered in lieu of degree
- Ophthalmic experience strongly preferred
- Ability to work independently and 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
- Ability to remotely problem-solve with site staff
- Travel requirements less than 10%
Benefits:
- Comprehensive Medical, Dental and Vision healthcare options beginning day 1
- Flexible PTO
- Unlimited sick time
- 14 company paid holidays
- 401K plan through Fidelity with company match
- Adoption and fertility assistance
- 16 weeks paid parental leave
- Company-paid life insurance
- Company-paid disability insurance
- Remote workspace reimbursement
- Wellness reimbursement
- Employee Assistance Program
- Career development opportunities
- Opportunities to work with colleagues across the globe
- Opportunity to research new ophthalmic therapies impacting patients globally
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