Clinical Development Associate

This is a fully remote position, open to applicants in Kentucky, +13 more states.

📋 Description

• Assist the clinical development team by providing scientific and medical oversight during the study startup, enrollment, execution, database lock, and study conclusion.

• Aid in Medical Monitoring tasks and patient data cleaning activities, including management of medical monitor queries.

• Recognize clinical risks and contribute to the development of mitigation strategies.

• Assist in the creation of study protocols, protocol amendments, informed consent forms, case report forms, and other clinical study documentation.

• Help resolve protocol inquiries, eligibility assessments, deviations, and challenges related to study execution.

• Ensure that clinical studies adhere to protocol specifications, ICH-GCP standards, relevant regulations, and Aurion SOPs.

• Collaborate with Biometrics and/or Data Management to establish data review plans and guarantee data integrity.

• Evaluate clinical, efficacy, safety, imaging, and biomarker/pharmacokinetic data.

• Participate in the preparation for regulatory meetings and engage with global health authorities.

• Assist in the development of briefing documents, responses to agency inquiries, and submission materials.

• Provide scientific content for INDs, CTAs, annual reports, clinical study reports, and marketing applications.

• Work with Clinical Operations, Medical Affairs, Regulatory Affairs, Biometrics, Pharmacovigilance, Quality Assurance, CRO partners, imaging centers, and other vendors.

• Support activities aimed at inspection readiness and participate in audits and regulatory inspections.

• Contribute to ongoing process improvement initiatives within Clinical Development.

• Foster a collaborative, high-performance culture that aligns with Aurion Biotech’s mission and values.

⛳️ Requirements

• Solid foundation in ophthalmology, experience in ophthalmology clinical trials, and proficiency in interpreting ophthalmology data, including visual acuity procedures and image collection.

• Preferred Bachelor’s degree in life sciences, nursing, or a related discipline.

• 1-3 years of clinical research experience, with exposure to clinical trial operations in a sponsor, CRO, or academic environment, particularly supporting Phase 2 or 3 clinical trials.

• Familiarity with study startup, site management, closeout procedures, and inspection readiness protocols.

• Working knowledge of ICH/GCP guidelines and clinical trial methodologies.

• Exceptional organizational and time management abilities; detail-oriented and capable of handling multiple responsibilities.

• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).

• Experience with TMF, EDC, and other clinical trial management systems is a plus.

• Strong interpersonal and communication skills, both written and verbal.

• Ability to work effectively within a team environment and across global teams and vendors.

• Excellent written, verbal, and interpersonal communication abilities; capable of impactful communication with diverse internal and external stakeholders.

• Demonstrated cultural agility, integrity, and enthusiasm for advancing transformative science.

• Willingness to travel up to 15%.

• Strong alignment with and commitment to Aurion Biotech’s mission, vision, and core values.

🏝️ Benefits

• Comprehensive health insurance for employees and their families.

• 401(k) matching program.

• Employee Assistance Program (EAP).

• Flexible Spending Account (FSA).

• Generous Paid Time Off (PTO).

• Paid parking accommodations.

• Subsidized commuter passes.

• In-office catered meals.

• Team-building events.

• Community engagement projects.

• Competitive compensation packages.