Senior Clinical Research Associate - Freelance
TFS HealthScience
About The Position
TFS HealthScience is seeking a Freelance Senior Clinical Research Associate at 0.4 FTE in Poland to join its CDS Ophthalmology team. The role independently manages investigator sites throughout the clinical trial lifecycle, ensuring studies comply with protocols, ICH-GCP guidelines, SOPs, and applicable regulatory requirements. The Senior Clinical Research Associate works with project teams, investigators, vendors, and other stakeholders to meet study milestones, maintain site quality and compliance, and support audit and inspection readiness.
Requirements
- Bachelor's degree in Life Sciences or a related field.
- 3–5 years of independent clinical monitoring experience as a CRA or Senior CRA.
- At least 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 and drive 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.
Benefits
- Competitive compensation package.
- Comprehensive benefits.
- Opportunity for personal and professional growth.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
Upload and Match Resume
What This Job Offers
Career Level
Senior
