Senior Clinical Research Associate - Freelance

TFS HealthScience•Auburn, ME

10d

About The Position

TFS HealthScience is hiring a freelance Senior Clinical Research Associate at 0.4 FTE in Poland to join its CDS Ophthalmology team. The role has full ownership of assigned investigator sites throughout the clinical trial lifecycle, ensuring studies comply with protocols, ICH-GCP guidelines, SOPs, and applicable regulatory requirements. The position involves site management and monitoring, documentation and data review, compliance oversight, issue resolution, and collaboration with project teams and other stakeholders. Travel within Poland is required as needed.

Requirements

Bachelor's degree in Life Sciences or a related field.
Minimum 3–5 years of independent clinical monitoring experience as a CRA or Senior CRA.
Minimum 1 year of experience in Ophthalmology clinical trials, including Retinopathy, Age-Related Macular Degeneration (AMD), and/or Diabetic Macular Edema (DME) studies.
Strong knowledge of ICH-GCP, clinical trial regulations, and monitoring best practices.
Demonstrated experience independently conducting all monitoring visit types.
Excellent site management, communication, and problem-solving skills.
Ability to travel within Poland as required.

Responsibilities

Independently manage assigned investigator sites throughout the entire study lifecycle.
Conduct feasibility, pre-study, site initiation, routine monitoring, co-monitoring, quality oversight, and close-out visits.
Ensure study milestones and site deliverables are achieved according to timelines.
Verify source data and ensure accurate completion of Case Report Forms (CRFs).
Review informed consent documentation, regulatory files, essential documents, and investigational product accountability records.
Identify, document, and resolve protocol deviations and data discrepancies.
Prepare monitoring reports, follow-up communications, and site correspondence.
Ensure site personnel are appropriately trained and qualified to conduct study activities.
Monitor site performance metrics and proactively address compliance or quality issues.
Escalate risks and issues appropriately while driving timely resolution.
Support audit and regulatory inspection readiness activities.
Collaborate with project teams, investigators, vendors, and cross-functional stakeholders.
Participate in study meetings, training sessions, and project-related activities.