Senior Clinical Research Associate

TFS HealthScience•Amsterdam, OH

1d•Remote

About The Position

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.

Requirements

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.

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.