Note: The job is a remote job and is open to candidates in USA. Aurion Biotech is a clinical-stage biotechnology company developing regenerative therapies to restore vision, including an allogeneic cell therapy for corneal disease. The Clinical Operations Scientist supports ophthalmology clinical programs through study execution, protocol and clinical document development, data review, regulatory submissions, risk management, and scientific dissemination.
Responsibilities
- Reports to Clinical Operations and under the guidance of the Sr. Clinical Operations Scientist and Director of Scientific Operations, serves as a scientific partner supporting Clinical Development for one or more ophthalmology clinical programs
- Supports study startup, conduct, monitoring, closeout, and inspection readiness activities under the guidance of senior team members
- Participates in investigator meetings, data review meetings, and cross-functional clinical trial team meetings
- Assists with site feasibility assessments and provides scientific support to investigators and study site personnel
- Helps identify and escalate scientific and clinical risks related to study execution
- Contributes to the development of clinical development plans, target product profiles, and overall program strategies
- Assists in translating development objectives into clinical study designs and operationally feasible protocols
- Supports the authoring and review of study protocols, informed consent forms, investigator brochures, clinical study reports, and other clinical study documents
- Provides scientific support for ophthalmic assessments, endpoint selection, imaging strategies, and study conduct activities
- Participates in the ongoing medical and scientific review of clinical trial data as assigned
- Collaborates with Biostatistics and Data Management teams to support data quality and integrity
- Assists in the analysis of emerging safety and efficacy data with guidance from the clinical development team to support program decisions
- Contributes to the interpretation of clinical study results and the preparation of scientific summaries and presentations for internal stakeholders
- Supports regulatory submissions, including INDs, CTAs, annual reports, briefing documents, and responses to regulatory authority questions
- Ensures assigned activities are conducted in compliance with ICH-GCP, applicable regulations, internal SOPs, and ethical standards
- Contributes to abstracts, manuscripts, posters, and presentations for scientific meetings and peer-reviewed publications
- Develops collaborative relationships with investigators, study coordinators, key opinion leaders, and scientific advisors
- Supports the planning and execution of scientific advisory boards and investigator meetings
- Works closely with Clinical Development, Medical Affairs, Regulatory Affairs, Biometrics, Quality Assurance, and external vendors to support study objectives
- Assists with preparation for regulatory inspections, audits, and quality reviews
- Maintains current knowledge of ophthalmology, clinical research practices, and applicable regulatory requirements through ongoing learning and professional development
- Ensure compliance with GCP, ICH, Aurion SOPs, and CRO SOPs
- Performs other duties as assigned by clinical scientific operations to support clinical trials
Skills
- Bachelor's degree with 4-6 years of experience, Master's degree with 2-4 years of experience or PhD with up to 2 years of experience in clinical research or clinical development. Degree must be in life sciences, nursing, or related field
- Familiarity with study start-up, data cleaning, 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 data visualization tools, TMF, EDC, and other clinical trial systems
- 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%, candidates local to an office may be asked to periodically travel to the office for meetings or clinical operations department support
- A strong alignment with, and commitment to, Aurion Biotech's mission, vision, and core values
- Exposure to clinical trial operations, either in a sponsor, CRO, or academic setting supporting Phase 1, 2 or 3 clinical trials, ophthalmology experience preferred
Benefits
- Remote work (WA or MA preferred; candidates based in specified states will be considered)
- Full health insurance for employees and their families
- 401(k) matching
- Employee Assistance Program (EAP)
- Flexible Spending Account (FSA)
- Paid parking
- Subsidized commuter passes
- In-office catered lunches
- Team events
- Community projects
Company Overview
Company H1B Sponsorship