Senior Clinical Research Associate

This is a fully remote position, open to applicants in Poland.

📋 Description

• Independently organize, execute, and follow up on pre-study assessments, site initiation, routine monitoring, and close-out visits, both on-site and remotely, according to the applicable monitoring plan.

• Supervise study site performance, including recruitment progress, and deliver continuous support to sites regarding study-related inquiries and operational challenges.

• Evaluate eCRF data, timelines, and queries; detect and report protocol deviations; and maintain effective communication with project management and sponsors.

• Review and uphold study documentation at the site level, including Investigator Site Files (ISF), ensuring readiness for inspection and compliance with relevant regulations.

• Collaborate across various functions with medical, project management, quality management, and data management teams, while assisting sites during audits and inspections.

⛳️ Requirements

• A degree in a scientific or medical discipline, or completed vocational training in a pertinent healthcare or medical field.

• Extensive knowledge of GCP, ICH guidelines, and clinical research processes, with a strong emphasis on accuracy in managing study data and regulatory obligations.

• At least 5 years of experience as a CRA and a minimum of 1 year of experience in Ophthalmology.

🏝️ Benefits

• Competitive compensation package

• Comprehensive benefits

• Opportunity for personal and professional growth