Senior Clinical Research Associate - Freelance

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 Research Associate - 0.4 FTE in Poland.

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.

As a Senior Clinical Research Associate, you will take full ownership of investigative sites throughout the clinical trial lifecycle, ensuring studies are conducted in compliance with protocols, ICH-GCP guidelines, SOPs, and applicable regulatory requirements.

Key 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 high-quality 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 closely with project teams, investigators, vendors, and cross-functional stakeholders.

• Participate in study meetings, training sessions, and project-related activities.

Qualifications: 

• Bachelor's degree in Life Sciences or a related field.

• Minimum 3-5 years of independent clinical monitoring experience as a CRA or Sr 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.

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.