TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.
Join Our Team as a Senior Clinical Research Associate - home based in Poland.
About this role
As part of our Ophthalmology team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.
Key Responsibilities:
Independently plan, conduct, and follow up on pre-study, site initiation, routine monitoring, and close-out visits, both on-site and remotely, in line with the applicable monitoring plan
Oversee study site performance, including recruitment progress, and provide ongoing support to sites on study-related questions and operational issues
Review eCRF data, timelines, and queries; identify and report protocol deviations; and maintain clear communication with project management and sponsors
Review and maintain study documentation at site level, including Investigator Site Files (ISF), ensuring inspection readiness and compliance with applicable regulations
Collaborate cross-functionally with medical, project management, quality management, and data management teams, and support sites during audits and inspections
Qualifications
Degree in a scientific or medical discipline, or completed vocational training in a relevant healthcare or medical field
Strong knowledge of GCP, ICH guidelines, and clinical research processes, with a high level of accuracy in handling study data and regulatory requirements
Minimum 5 years experience working as a CRA and 1 year experience in Ophthalmology
What We Offer
We provide a competitive compensation package, comprehensive benefits and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients
A Bit More About Us
Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology and Ophthalmology.
Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration.
Together we make a difference.