Sr. Clinical Trials Associate II

Glaukos Corporation • Aliso Viejo, CA

1d

About The Position

The Sr. Clinical Trials Associate II is responsible for the coordination of clinical research studies in compliance with U.S. and international regulations under the guidance of a Clinical Manager or Clinical Director. The Senior Clinical Trials Associate II will play a critical role in managing and coordinating the planning, execution, and completion of clinical trials focused on ophthalmology combination products. This role requires an experienced clinical research professional with a strong understanding of clinical trial operations and regulatory requirements, who can independently lead study-related activities and contribute to process improvements. The Senior Clinical Trials Associate will work closely with cross-functional teams, lead site management activities, ensure regulatory compliance, and mentor junior team members.

Requirements

• 8 or more years of experience in clinical research, ideally within ophthalmology or combination products.

Responsibilities

• Lead the creation, maintenance, and compliance of essential study documentation, including trial master files, informed consent forms, and regulatory submissions, ensuring alignment with SOPs and industry regulations.
• Oversee communication with clinical sites and vendors, managing site activities such as initiation, monitoring, and close-out visits, and proactively resolving site-related issues. May also have responsibility for site contracts.
• Provide support and information to Clinical Research Associates, Clinical Relations Managers, and Surgical Specialists.
• Ensure the timely collection, verification, and tracking of clinical trial data, coordinating with data management teams to ensure accuracy and adherence to study protocols.
• Ensure trial adherence to GCP, FDA, and other regulatory standards, while maintaining high quality across study processes.
• Act as a liaison with Clinical Operations, CMC, Finance, Business Systems, and research teams, aligning project objectives and supporting efficient, high-quality study operations.
• Serve as a mentor to Clinical Trials Associates I and II, offering training, guidance, and best practices to enhance team capabilities.
• Participate in process improvement initiatives to optimize clinical trial operations.

Benefits

• competitive salary (based on experience)
• bonus eligibility
• medical/dental/vision
• life insurance
• stock options
• 401(k) Employer Match
• Employee Stock Purchase Program
• generous time off & paid holidays
• time-off to volunteer in the community

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed