Clinical Development Associate

Aurion Biotech is a clinical-stage biotechnology company developing regenerative therapies to restore vision. The Clinical Development Associate supports clinical trial execution and oversight, including data and safety review, study documentation, risk mitigation, and cross-functional collaboration across clinical programs.

Responsibilities

• Support the clinical development team with ongoing scientific and medical oversight and support throughout study startup, enrollment, conduct, database lock, and study closeout
• Support Medical Monitoring activities and contribute to patient cleaning activities, including assisting with medical monitor query management
• Identify clinical risks and proactively help develop mitigation strategies
• Support the clinical scientist with development of study protocols, protocol amendments, informed consent documents, case report forms, and other clinical study documents
• Collaborate with the clinical scientist to help address protocol questions, eligibility determinations, deviations, and study conduct challenges
• Ensure clinical studies are conducted in accordance with protocol requirements, ICH-GCP, applicable regulations, and Aurion SOPs
• Partner with Biometrics and/or Data Management to help develop data review plans and ensure data quality
• Support ongoing review of clinical, efficacy, safety, imaging, and biomarker/pharmacokinetic data
• Assist members of clinical development with contribution to regulatory meeting preparation and interactions with global health authorities, as assigned
• Support preparation of briefing documents, responses to agency questions, and submission documents, as assigned
• Assist with the contribution of scientific content for INDs, CTAs, annual reports, clinical study reports, and marketing applications
• Partner closely with Clinical Operations, Medical Affairs, Regulatory Affairs, Biometrics, Pharmacovigilance, Quality Assurance, and external 3rd party vendors including CRO partners and imaging centers
• 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's mission and values

Preferred

• Bachelor's degree in life sciences, nursing, or related field preferred
• experience with TMF, EDC, and other clinical trial systems a plus
• Life Sciences
• Nursing
• TMF
• EDC
• Clinical Trial Systems

Benefits

• 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
• Remote work (WA or MA preferred; candidates based in IN, MA, NC, NJ, NH, NM, NY, PA, SC, SD, TX, KY, WI, MS or WA will be considered)

Company

• Clinical-stage biotech developing corneal endothelial cell therapies for blindness
• Seattle, Washington, USA
• https://aurionbiotech.com/
• Founded in 2021
• 51-200 employees

Qualifications

• A strong background in ophthalmology, ophthalmology clinical trials, and interpretation of ophthalmology data including visual acuity procedures and image collection
• 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)
• 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
• A strong alignment with, and commitment to, Aurion Biotech's mission, vision, and core values
• Bachelor's degree in life sciences, nursing, or related field preferred
• Experience with TMF, EDC, and other clinical trial systems a plus
• 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.

Required skills

• Clinical Research, Clinical Trial Operations, EDC, ICH-GCP, Image Collection, Ophthalmology Clinical Trials, Ophthalmology Data Interpretation, Phase 2/3 Clinical Trials, TMF, Visual Acuity Procedures

Experience

• 1-3 years