Sr Clinical Research Associate; Sr CRA - Ophthalmology-Remote

Job Location

CANDIDATE MUST RESIDE IN ONE OF THE FOLLOWING LOCATIONS:
Texas, Illinois, Indiana, Ohio, Tennessee.

The role is responsible for performance and compliance of assigned protocols and sites in a country, ensuring compliance with ICH/GCP, local regulations, company policies, quality standards, and adverse event reporting requirements.

• Develop and maintain strong relationships with site staff, ensuring continuity throughout trial phases.
• Perform clinical study site management and monitoring activities in compliance with ICH-GCP, Sponsor SOPs, local laws and regulations, and study protocols.
• Gain a comprehensive understanding of study protocols and related procedures.
• Coordinate and manage tasks with sponsor roles to achieve Site Ready status.
• Participate in site selection and validation activities.
• Perform remote and on‑site monitoring and oversight to ensure data integrity and protect subject rights, safety, and well‑being.
• Conduct site visits, including validation, initiation, monitoring, close‑out, and record clear, timely reports.
• Collect, review, and monitor regulatory documentation for study start‑up, maintenance, and close‑out.
• Communicate with investigators and site staff on protocol conduct, recruitment, retention, deviations, documentation, audits, inspections, and overall performance.
• Identify, assess, and resolve site performance, quality, or compliance issues, escalating as defined.
• Collaborate with internal operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, HQ functions, vendors, IRB/IECs, and regulatory authorities.
• Maintain information and documentation in CTMS, eTMF, and other systems per timelines.
• Share best practices, recommend improvements, and provide training as a process subject‑matter expert.
• Support or lead audit/inspection activities.
• Assist in finding and developing new potential sites, following country strategy.
• Mentor junior CRAs and perform co‑monitoring visits when appropriate.
• Conduct quality control visits if delegated and appropriately trained.

• Ability to travel domestically and internationally approximately 65%‑75% of working time.
• Expected travel: 2–3 days per week.
• Current driver’s license required.

• Fluency in local languages and English (verbal and written) with excellent communication skills.
• Comprehensive understanding of clinical research, trial phases, and GCP/ICH guidelines.
• Knowledge of global, country, and regional clinical research guidelines.
• Leadership, mentoring, and hands‑on documentation practice.
• Independent site management skills, patient recruitment, and monitoring judgment.
• IT proficiency with MS Office and clinical IT applications across devices.
• Data analysis and metric interpretation in virtual environments.
• Experience conducting site motivational visits to boost enrollment.
• Problem‑solving and root‑cause analysis with corrective action implementation.
• Mentoring capabilities for junior CRAs during co‑monitoring.

• Effective time management, organization, conflict management, and problem solving.
• Highly independent across multiple protocols, sites, and therapy areas.
• Accountable, urgent, and prioritizes tasks in changing environments.
• Works effectively in a matrix multicultural environment with cultural sensitivity.
• Customer‑focus, high quality, compliance mindset.
• Positive and growth mindset, self‑driven.
• Professional demeanor and communication consistent with policies.

• Associate’s degree or equivalent in a scientific/healthcare discipline with at least 7 years of relevant healthcare experience, including 4 years of direct site management in bio‑pharma/CRO.
• 5 years of ophthalmology experience required; retina experience preferred.
• Alternatively, Bachelor’s degree or higher with at least 4 years of direct site management in bio‑pharma/CRO.
• 5 years of ophthalmology experience required; retina experience preferred.

• Adverse Event Reporting, Clinical Data Management, Clinical Development, Clinical Research Organization Management, Study Management, Trial Compliance,…