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

Location Requirement Candidate must reside in one of the following locations: Texas, Illinois, Indiana, Ohio, Tennessee. Overview The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA‑Manager or CRD, the individual ensures compliance of study conduct with ICH/GCP, country regulations, company policies, quality standards, and adverse event reporting requirements internally and externally. Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. Actively develops and expands the territory for clinical research, finding and developing new sites. Responsibilities Develop strong site relationships and ensure continuity of site relationships through all phases of the trial. Perform clinical study site management/monitoring activities in compliance with ICH‑GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. Gain an in‑depth understanding of the study protocol and related procedures. Coordinate & manage various tasks in collaboration with other sponsor roles to achieve Site Ready. Participate & provide inputs on site selection and validation activities. Conduct remote and on‑site monitoring & oversight activities using various tools to ensure data generated at the site are complete, accurate and unbiased and that subjects’ rights, safety and well‑being are protected. Conduct site visits including validation, initiation, monitoring, close‑out visits and record clear, comprehensive and accurate visit & non‑visit contact reports in a timely manner. Collect, review, and monitor required regulatory documentation for study start‑up, maintenance and close‑out. Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, deviations, regulatory documentation, audits/inspections and overall site performance. Identify, assess and resolve site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway. Work in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites. Manage and maintain information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines. Contribute strongly to CRA team knowledge by acting as a process SME, sharing best practices, making recommendations for continuous improvement and providing training as appropriate. Support and/or lead audit/inspection activities as needed. Mentor junior CRAs on process/study requirements and perform co‑monitoring visits where appropriate. Possibly perform quality control visits if delegated and trained appropriately. Travel domestically and internationally approximately 65%–75% of working time; expected travel ~2–3 days/week. Current driver’s license required. Qualifications & Experience Associate’s degree, certificate or equivalent in a scientific/healthcare discipline with at least 7 years of relevant healthcare experience, including at least 4 years of direct site management experience in a bio/pharma/CRO. 5 years Ophthalmology experience required (Retina experience preferred). Bachelor’s degree (or above) with at least 4 years of direct site management experience in a bio/pharma/CRO. 5 years Ophthalmology experience required (Retina experience preferred). Strong knowledge of GCP/ICH guidelines and country clinical research law & guidelines. Proven skills in site management and independent monitoring with professional judgment. Good IT skills – use of MS Office and various clinical IT applications on computer, tablet and mobile devices. Experience with conducting site motivational visits designed to boost site enrollment. Ability to perform root cause analysis and implement corrective actions. Core Competencies Fluent in local languages and English, excellent communication skills. Effective time management, organization, conflict management, problem solving. Ability to work independently across multiple protocols, sites and therapy areas. High sense of accountability and urgency; excellent prioritization in changing environments. Works effectively in a matrix multicultural environment and maintains culturally sensitive relationships. Customer focus and high quality, compliance mindset. Benefits & Salary Salary range: $129,000.00 – $203,100.00. Successful candidate will be eligible for annual bonus and long‑term incentive, if applicable. Benefits include medical, dental, vision, health care and other insurance benefits for employee and family, retirement benefits including 401(k), paid holidays, vacation, and compassionate and sick days. EEO & Applicant Rights Merck & Co., Inc. is an Equal Employment Opportunity Employer. We provide equal opportunities to all employees and applicants for employment 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 applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under U.S. Equal Opportunity Employment laws, visit the EEOC website. #J-18808-Ljbffr