Key Skills

Job Description

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 Freelance Senior Clinical Research Associate 0.2 FTE. About This Role As part of our CDS Ophthalmology team you will be working alongside passionate and innovative professionals to ensure our customers achieve their goals. The Freelance Senior Clinical Research Associate is responsible f­­­­­­­­or conducting site monitoring visits and providing oversight of study-related activities to ensure compliance with the clinical protocol, ICH-GCP guidelines, and applicable regulatory requirements. The contractor will support issue identification and resolution, maintain effective working relationships with investigative site personnel, and provide operational oversight to support successful study execution and data quality throughout the duration of the trial. Key Responsibilities Take ownership of investigative sites from site activation through study close-out. Conduct Site Qualification Visits (SQV), Site Initiation Visits (SIV), routine Monitoring Visits (MV), Quality Oversight Visits, co-monitoring visits, and Close-Out Visits (COV). Ensure site compliance with study protocols, ICH-GCP guidelines, and applicable regulatory requirements. Verify source documentation, informed consent processes, investigational product accountability, and essential regulatory documentation. Identify, document, communicate, and escalate protocol deviations, compliance concerns, and study risks. Ensure study milestones are achieved according to timelines, including site activation, patient recruitment, database analyses, and study close-out. Build and maintain strong relationships with investigators and site personnel to support successful study delivery. Ensure site staff are appropriately trained and qualified throughout the duration of the study. Prepare accurate and timely monitoring reports, follow-up letters, and study documentation. Collaborate closely with cross-functional teams, study management, and sponsor stakeholders. Support audit and inspection readiness activities as required. Qualifications Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field. Minimum 3-5 years of independent clinical monitoring experience as a CRA, including minimum 1 year of experience in Ophthalmology especially retinal diseases such as: Age-Related Macular Degeneration (AMD), Geographic Atrophy (GA), Diabetic Retinopathy, Diabetic Macular Edema, Inherited Retinal Disorders Experience with Gene Therapy or Advanced Therapy programs. Strong knowledge of ICH-GCP, clinical trial regulations, and monitoring practices. Fluency in Dutch (native or bilingual level) and professional proficiency in English. 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.

Core Responsibilities

Manage investigative sites from activation through close-out, conducting qualification, initiation, routine monitoring, oversight, and close-out visits. Ensure protocol and regulatory compliance, maintain data quality and study documentation, resolve and escalate issues, and collaborate with site staff, study teams, and sponsors.

Requirements

Requires a bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field, plus 3–5 years of independent CRA monitoring experience, including at least one year in ophthalmology, particularly retinal diseases. Candidates must have experience with gene therapy or advanced therapy programs, strong ICH-GCP and regulatory knowledge, and native or bilingual Dutch with professional English proficiency.

Benefits

• Comprehensive Benefits
• Personal and Professional Growth