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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical study conduct, regulatory compliance, and documentation management, with a strong focus on GCP/ICH regulations and ophthalmic projects. Proven ability to support project management and maintain electronic trial master files while ensuring data integrity and quality control.
Highest-signal resume keywords
Clinical Trials Associate ExperienceGCP/ICH Regulations KnowledgeElectronic Trial Master File MaintenanceOphthalmic ExperienceAnalytical And Problem-Solving Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Study ConductRegulatory Document CollectionStudy Documentation DevelopmentData CollectionSite ManagementTrial Master File ManagementRegulatory Package PreparationSOP ComplianceBudget ManagementFeasibility Assessment
Soft Skills
Excellent Verbal And Written CommunicationOrganizational SkillsTime ManagementAttention To DetailAbility To Work Independently
Tools & Technologies
Clinical Study Tracking SystemsFile-Sharing PlatformsRegulatory BindersInvestigator Site File Trackers
Industry Keywords
Ophthalmic ProjectsGCP ComplianceClinical Trial ManagementRegulatory RequirementsAudit Preparation
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- 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