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.

• 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.

• 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.

• Fluent in local languages and English, excellent communication skills.
• Effective time management, organization, conflict management, problem solving.
• Ability…