Sr Clinical Research Associate (Sr CRA) - Ophthalmology-Remote

Job Location CANDIDATE MUST RESIDE IN ONE OF THE FOLLOWING LOCATIONS: Texas, Illinois, Indiana, Ohio, Tennessee. Job Description 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. Responsibilities 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. Travel Requirements Ability to travel domestically and internationally approximately 65%‑75% of working time. Expected travel: 2–3 days per week. Current driver’s license required. Core Competency Expectations 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. Behavioral Competency Expectations 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. Experience and Educational Requirements 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. Required Skills Adverse Event Reporting, Clinical Data Management, Clinical Development, Clinical Research Organization Management, Study Management, Trial Compliance, Documentation, Planning, Monitoring, Early Development, Preventive Action, Regulatory Affairs Compliance, Site Management. Salary and Benefits Salary range: $129,000.00 – $203,100.00, paid in good faith based on qualifications, experience, location, and business needs. Eligible for an annual bonus and long‑term incentive, if applicable. Benefits include medical, dental, vision, retirement, 401(k), paid holidays, vacation, and compassionate and sick days. Equal Employment Opportunity We provide equal opportunities for all employees and applicants and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. As a federal contractor, we comply with affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under U.S. Equal Opportunity Employment laws, visit EEOC resources. Requisition ID

R406333