Sr Clinical Research Associate; Sr CRA - Ophthalmology-Remote

Job Description

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

Ophthalmology experience required.

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 person ensures compliance of study conduct with ICH/GCP and country regulations, company policies and procedures, 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. Participates in internal meetings and work streams as SME for monitoring processes and systems.

• Develop strong site relationships and ensure continuity through all trial phases.
• 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.
• Perform remote and on‑site monitoring & oversight activities using various tools to ensure: data generated at site are complete, accurate and unbiased and subjects’ rights, safety and well‑being are protected.
• Conduct site visits including validation, initiation, monitoring, close‑out visits; 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, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
• Identify, assess and resolve site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway in collaboration with CRA Manager, CRM, TA Head and CRD as needed.
• 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 to support assigned sites.
• Manage and maintain information and documentation in CTMS, eTMF and other systems per timelines.
• Contribute strongly to CRA team knowledge by acting as process SME, sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
• Support and/or lead audit/inspection activities as needed.
• Following the country strategy defined by CRD and CRA Manager, contribute to the identification of new potential sites and work closely with them to develop strong clinical research capabilities.
• Mentor / buddy junior CRAs on process/study requirements and perform co‑monitoring visits where appropriate.
• Perform quality control visits if delegated by other roles and trained appropriately.

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

• Fluent in local languages and English (verbal and written) and excellent communication skills.
• Excellent understanding of clinical research, phases of clinical trials, GCP/ICH & country clinical research law & guidelines.
• Proficiency in Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
• Demonstrated ability to mentor/lead.
• Hands‑on knowledge of Good Documentation Practices.
• Proven skills in site management including independent management of site performance and patient recruitment.
• High level of monitoring skill with independent professional judgment.
• Good IT skills (use of MS Office, various clinical IT applications on computer, tablet and mobile devices)…