Clinical Trial Associate I

Ora

. Assist Project Managers and study teams in conducting ophthalmic clinical studies .

Posted 9/24/2026contractRemoteJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing ophthalmic clinical studies, ensuring compliance with GCP/ICH regulations, and maintaining electronic trial master files. Possesses strong organizational, analytical, and communication skills to support project management and facilitate effective collaboration in a cross-functional team environment.

Highest-signal resume keywords

Ophthalmic Clinical Trial ExperienceGCP/ICH Regulations KnowledgeElectronic Trial Master File MaintenanceRegulatory Document PreparationAnalytical and Problem-Solving Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ManagementRegulatory Document CollectionStudy Documentation ComplianceData Collection and ManagementFeasibility OversightBudget ManagementSite Contract ManagementIRB/IEC Submission PreparationQuality Control AuditingProcess Improvement

Soft Skills

Excellent Verbal and Written CommunicationOrganizational SkillsTime ManagementAttention to DetailTeam Collaboration

Tools & Technologies

ETMFCTMSFile-Sharing PlatformsStudy Trackers

Industry Keywords

Ophthalmic StudiesClinical ResearchSOP ComplianceTrial Master FileRegulatory Requirements

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

Inclusive and supportive work environment
Fulfilling work-life balance
Equal employment opportunity and fair, equitable compensation
Up to 10% travel opportunity/requirement