Clinical Development Associate

Aurion Biotech

. Support the clinical development team with scientific and medical oversight throughout study startup, enrollment, conduct, database lock, and study closeout .

Posted 10/27/2026full-timeRemote • United StatesJuniorMid-Level💰 $92,000 - $120,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial operations, particularly in ophthalmology, with a strong focus on compliance with ICH-GCP guidelines and regulatory requirements. Proficient in developing clinical study documents and managing data quality while fostering collaboration across multidisciplinary teams.

Highest-signal resume keywords

Ophthalmology Clinical TrialsICH/GCP GuidelinesClinical Trial OperationsData ManagementRegulatory Submissions

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study Protocol DevelopmentMedical MonitoringRisk Identification and MitigationData Review and AnalysisClinical Trial Documentation

Soft Skills

Strong Organizational SkillsTime ManagementInterpersonal CommunicationTeam CollaborationCultural Agility

Tools & Technologies

Microsoft OfficeTMF SystemsEDC SystemsClinical Trial Management Systems

Industry Keywords

Clinical ResearchPhase 2 TrialsPhase 3 TrialsRegulatory AffairsBiometrics

About the role

Key responsibilities & impact

Support the clinical development team with scientific and medical oversight throughout study startup, enrollment, conduct, database lock, and study closeout
Support Medical Monitoring activities and patient cleaning activities, including medical monitor query management
Identify clinical risks and help develop mitigation strategies
Support development of study protocols, protocol amendments, informed consent documents, case report forms, and other clinical study documents
Help address protocol questions, eligibility determinations, deviations, and study conduct challenges
Ensure clinical studies comply with protocol requirements, ICH-GCP, applicable regulations, and Aurion SOPs
Partner with Biometrics and/or Data Management to develop data review plans and ensure data quality
Review clinical, efficacy, safety, imaging, and biomarker/pharmacokinetic data
Contribute to regulatory meeting preparation and interactions with global health authorities
Support briefing documents, responses to agency questions, and submission documents
Contribute scientific content for INDs, CTAs, annual reports, clinical study reports, and marketing applications
Collaborate with Clinical Operations, Medical Affairs, Regulatory Affairs, Biometrics, Pharmacovigilance, Quality Assurance, CRO partners, imaging centers, and other vendors
Support inspection readiness activities and participate in audits and regulatory inspections
Contribute to continuous process improvement initiatives within Clinical Development
Support a collaborative, high-performance culture aligned with Aurion Biotech’s mission and values

Requirements

What you’ll need

Strong background in ophthalmology, ophthalmology clinical trials, and interpretation of ophthalmology data including visual acuity procedures and image collection
Bachelor’s degree in life sciences, nursing, or related field preferred
1-3 years of experience in clinical research, including exposure to clinical trial operations, either in a sponsor, CRO, or academic setting supporting Phase 2 or 3 clinical trials
Familiarity with study start-up, site maintenance, closeout, and inspection readiness processes
Working knowledge of ICH/GCP guidelines and clinical trial processes
Strong organizational and time management skills; detail-oriented and able to manage multiple tasks
Proficient in Microsoft Office (Word, Excel, PowerPoint)
Experience with TMF, EDC, and other clinical trial systems a plus
Strong interpersonal and communication skills, both written and verbal
Ability to work effectively in a team environment and across global teams and vendors
Excellent written, verbal, and interpersonal communication skills; ability to communicate with impact across diverse internal and external stakeholders
Demonstrated cultural agility, integrity, and a passion for advancing transformative science
Ability to travel up to 15%
Strong alignment with, and commitment to, Aurion Biotech’s mission, vision, and core values

Benefits

Comp & perks

Full health insurance for employees and their families
401(k) matching
EAP
FSA
Generous PTO
Paid parking
Subsidized commuter passes
In-office catered lunches
Team events
Community projects
Competitive compensation packages