Clinical Research Coordinator (1‑year contract)

About the role

The Clinical Research Coordinator will oversee daily activities of clinical trials at the investigational site, ensuring compliance with the protocol, ICH‑GCP, and local regulations while protecting participant safety and data quality.

Key responsibilities

• Assist the Principal Investigator in identifying, screening, and recruiting eligible participants.
• Guide subjects through the Informed Consent Form process and schedule visits to maximise retention.
• Prepare and submit IRB applications, amendments, and notifications.
• Maintain the Investigator Site File and ensure readiness for audits.
• Manage trial logistics, including investigational product accountability and specimen handling.
• Extract data from medical records and enter it into Electronic Data Capture (EDC) systems following ALCOA+ principles.
• Address data queries from Clinical Research Associates promptly.
• Support SAE processing and reporting within required timelines.
• Serve as primary contact for sponsors, CROs, and monitoring CRAs, coordinating site visits and inspections.

Required profile

• Bachelor’s degree in Nursing, Optometry, Medicine, Biomedical Sciences, Life Sciences or related field.
• Previous experience in clinical trials, preferably with medical devices or ophthalmology.
• Familiarity with visual acuity testing, refraction, corneal topography, axial length and pachymetry measurements is advantageous.
• Ability to read and interpret English research protocols, SOPs and related documents.

Required skills

• Proficiency with Microsoft Office (Excel, Word, PowerPoint).
• Experience using Electronic Data Capture (EDC) systems.
• Knowledge of ALCOA+ data‑quality principles.
• Understanding of IRB submission processes and investigational product handling.