Senior Clinical Research Associate

Job Description

We are seeking a highly experienced Senior Clinical Research Associate to play a vital role in ophthalmology research at TFS HealthScience. Your primary responsibilities will include: 1. Independently planning, conducting, and following up on pre-study, site initiation, routine monitoring, and close-out visits, both on-site and remotely, according to the monitoring plan. 2. Monitoring study site performance, including recruitment progress, and offering continuous support to sites regarding study-related inquiries and operational challenges. 3. Reviewing eCRF data, timelines, and queries, identifying and reporting protocol deviations, and keeping project management and sponsors well-informed. 4. Maintaining study documentation at the site level, including Investigator Site Files (ISF), ensuring readiness for inspections and adherence to applicable regulations. 5. Working with medical, project management, quality management, and data management teams, as well as assisting sites during audits and inspections.

Qualifications

To succeed in this role, you should possess the following qualifications: 1. A degree in a scientific or medical discipline, or completed vocational training in a relevant healthcare or medical field. 2. In-depth knowledge of GCP, ICH guidelines, and clinical research processes, with a high level of accuracy in handling study data and regulatory requirements. 3. At least 5 years of experience as a CRA and 1 year of experience in Ophthalmology.

Benefits

TFS HealthScience offers: - A competitive compensation package. - Comprehensive benefits to support your well-being. - Opportunities for personal and professional growth within the company.