[Remote] Clinical Research Associate (CRA) - Ophthalmology - US Any Region

Note: The job is a remote job and is open to candidates in USA. Parexel is a global clinical development partner delivering clinical and consulting solutions to the life sciences industry. The Clinical Research Associate will manage ophthalmology clinical sites from identification through closeout, conduct onsite monitoring, support enrollment, and help ensure study quality, patient safety, regulatory compliance, and accurate clinical data.

Responsibilities

• Conduct qualification visits (QV), site initiation visits (SIV), monitoring visits (MV), and termination visits (TV) at assigned clinical sites, and prepare timely visit and contact reports
• Manage site quality and delivery from site identification through closeout
• Serve as the primary point of contact for assigned clinical sites, addressing questions and resolving issues to support successful study execution
• Oversee study integrity and build effective relationships with investigators and site staff
• Review trial performance at designated sites and help safeguard the rights, safety, and well-being of study participants in accordance with the protocol
• Develop patient recruitment strategies with clinical sites to support enrollment timelines
• Ensure compliance with approved standard operating procedures, study protocols and amendments, Good Clinical Practice, and applicable regulatory requirements
• Evaluate the quality and integrity of reported data, site performance, and investigational product accountability
• Monitor the completeness and quality of regulatory documentation and perform site document verification

Skills

• Strong site relationship management, problem-solving, and communication skills
• The ability to work independently with urgency and limited oversight
• A client-focused, flexible approach to assignments and continuous learning
• The ability to manage multiple priorities, evaluate changing scenarios, apply study protocols, and meet project timelines
• An ethical, patient-focused approach and strong attention to quality and detail
• Comfort collaborating within a matrixed team and communicating clearly with internal and external stakeholders
• At least 18 months of direct onsite monitoring experience as a Clinical Research Associate
• Ophthalmology clinical trial monitoring experience
• Bachelor's degree or equivalent in biological science, pharmacy, or another health-related discipline
• Knowledge of Good Clinical Practice, applicable regulatory requirements, and clinical trial processes
• Experience using a Clinical Trial Management System, an Electronic Document Management System, and Microsoft Office applications, including Excel and Word
• Strong interpersonal, written, verbal, organizational, and problem-solving skills

Benefits

• Health, Vision & Dental Insurance
• Tuition Reimbursement
• Vacation/Holiday/Sick Time
• Flexible Spending & Health Savings Accounts
• Work/Life Balance
• 401(k) with Company match
• Pet Insurance
• World-class technology
• Training tailored to your experience
• Opportunities to work across therapeutic areas
• Pathways for continued growth within clinical research
• Paid time off
• Life insurance
• Additional benefit offerings in accordance with the terms of our applicable plans
• Remote work arrangement

Company Overview

Company H1B Sponsorship