Remote Ophthalmology Clinical Research Associate

Parexel; United States; Remote; USD 70,000 - 99,000; Full time

Benefits offered by this job

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Job summary

Parexel is seeking a Clinical Research Associate with Ophthalmology monitoring experience to manage clinical sites from identification through closeout, ensuring study quality, patient safety, regulatory compliance, and accurate clinical data. You will conduct onsite monitoring, build site relationships, address issues, and support enrollment while upholding GCP and regulatory standards.

Parexel offers world-class technology and tailored training with growth opportunities across therapeutic

Qualifications

• 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.

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

Onsite monitoring

Ophthalmology monitoring

Site relationship management

Communication skills

Independent work

Education

Bachelor's degree in biological sciences / pharmacy or health-related discipline

Tools

CTMS

Electronic Document Management System

Microsoft Office (Excel, Word)

Job description

Parexel is seeking a Clinical Research Associate with Ophthalmology monitoring experience to manage clinical sites from identification through closeout, ensuring study quality, patient safety, regulatory compliance, and accurate clinical data. You will conduct onsite monitoring, build site relationships, address issues, and support enrollment while upholding GCP and regulatory standards.

Parexel offers world-class technology and tailored training with growth opportunities across therapeutic