Regional CRA

Regional Clinical Research Associate, Ophthalmology Green Key Resources | Remote (West Coast Preferred) | Full Time Contract

W2 Contract (6 months, renewable - may roll perm) - Hourly Pay Rate is Flexible

About the Opportunity

We are partnering exclusively with a leading global clinical research organization on a Regional Clinical Research Associate opportunity with a focus in ophthalmology. This is a fully remote role with a preference for candidates based on the West Coast. If you have hands‑on ophthalmology monitoring experience and are ready to bring your expertise to a high‑quality global CRO, we want to hear from you.

About the Role

As a Regional CRA you will be responsible for monitoring clinical trial sites across your assigned region, ensuring protocol compliance, data integrity, and GCP adherence throughout the study lifecycle. You will serve as the primary point of contact for investigative sites and will work closely with the sponsor and internal study teams to ensure timely and quality execution of ophthalmology clinical trials.

Key Responsibilities
• Conduct site initiation, routine monitoring, and closeout visits at assigned investigative sites in accordance with ICH GCP, study protocols, and sponsor SOPs
• Serve as the primary site contact for all operational and regulatory questions throughout the study
• Review and verify source documentation, case report forms, and regulatory files to ensure accuracy and compliance
• Identify and elevate site issues, protocol deviations, and data discrepancies in a timely manner
• Maintain inspection‑ready trial master file documentation for all assigned sites
• Support site activation activities including feasibility assessments, site qualification visits, and regulatory document collection
• Track enrollment metrics and implement proactive site performance strategies to support study timelines
• Collaborate with cross‑functional study teams including data management, safety, and regulatory affairs

Qualifications
• Minimum 3 years of experience as a Clinical Research Associate or Regional CRA in a pharmaceutical, biotechnology, or CRO environment
• Minimum 1 year of direct ophthalmology clinical trial monitoring experience including Phase I programs
• Strong working knowledge of ICH GCP and FDA regulatory requirements
• Experience managing sites across a defined geographic region with independent travel and planning
• Proficiency with electronic data capture systems, eTMF platforms, and CTMS tools
• Excellent written and verbal communication skills with strong attention to detail
• Oncology monitoring experience is a plus
• Bachelor's degree in a life science, nursing, or healthcare related discipline preferred
• Ability to travel approximately 30 percent within assigned region

Why This Opportunity

This is an exciting opportunity to join a well‑established global CRO with a strong reputation for quality and scientific excellence across multiple therapeutic areas. You will work alongside experienced clinical development professionals in a collaborative and supportive environment with access to a broad portfolio of global programs.

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