Clinical Research Associate

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Logo of SpyGlass Pharma, Inc.

SpyGlass Pharma, Inc.

11 - 50 employees

Founded 2019

🧬 Biotechnology

💊 Pharmaceuticals

💰 $75M Series D - Spyglass Pharma on 2025-06

Biotechnology • Pharmaceuticals

<SpyGlass Pharma, Inc. > SpyGlass Pharma, Inc. is a clinical-stage company developing the BIM-IOL System, a sustained drug-delivery intraocular lens designed to deliver long-acting glaucoma therapy at the time of cataract surgery. The technology integrates glaucoma treatment with a trusted surgical procedure to address gaps in adherence and chronic disease management, and the company is advancing the device through preclinical studies and clinical trials (first-in-human, Phase 1/2, and Phase 3).

📋 Description

• Conduct site monitoring visits (initiation, routine, and close-out) to ensure compliance with the clinical protocol, GCP, and regulatory requirements. • Assist in the preparation and review of essential trial documents, such as informed consent forms, case report forms, and investigator brochures. • Collaborate with site staff to ensure proper documentation, timely data entry, and resolution of data queries. • Assist in the identification, selection, and training of investigative sites. • Maintain accurate and complete study files and records in accordance with GCP and company SOPs. • Monitor study progress to ensure timelines and quality standards are met. • Report site activities and findings to the Clinical Study Manager and escalate issues as necessary. • Support regulatory submissions by preparing clinical trial applications and maintaining relevant documentation. • Work collaboratively with cross-functional teams, including Regulatory Affairs, Quality Assurance, and Project Management, to achieve study objectives.

🎯 Requirements

• Bachelor's degree in life sciences, nursing, or a related field. • Minimum of 4 years of experience in clinical affairs within the pharmaceutical or medical device industry. • Knowledge of GCP, FDA/ICH guidelines, and clinical trial monitoring practices. • Strong organizational and problem-solving skills. • Excellent communication and interpersonal skills, with the ability to build strong relationships with investigative sites and internal teams. • Proficiency in Microsoft Office and electronic data capture (EDC) systems. • Ability to travel up to 50-75% domestically, as required.

🏖️ Benefits

• Comprehensive health, dental, and vision insurance plans to keep you and your family healthy and happy, with a variety of plan and coverage options. • Generous paid time off, including holidays, vacation days, and personal leave. • Annual Bonus opportunity. • Stock options, giving you a stake in the company’s future.

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