Job Description

About this role

TFS HealthScience is a leading global mid size Contract Research Organization that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service capabilities, resourcing and Functional Service solutions.

The Freelance Clinical Research Associate is responsible for monitoring activities including initiation, on site and remote monitoring and close out of assigned clinical study sites. This role ensures subject safety, data integrity and high quality study conduct within regulatory requirements and company procedures. The primary purpose of this assignment is to deliver monitoring support with a focus on clearing a backlog of source data verification and related data review activities.

As part of our SRS team, you will be dedicated to one sponsor, a global pharmaceutical company that is an industry leader in complex late phase clinical research. This assignment is expected to run until March 2026.

Key Responsibilities

• Conduct on site and remote monitoring visits in line with applicable SOPs, GCP, ICH and regulatory requirements
• Ensure patient safety and protocol compliance by verifying informed consent procedures and adherence to study guidelines
• Review CRFs and source documentation for completeness accuracy and overall data quality
• Oversee investigational product handling and accountability at sites
• Prepare timely monitoring visit reports issue lists and follow up actions and escalate issues when needed
• Maintain site level documentation in the eTMF and ensure site files meet regulatory standards
• Support audit and inspection preparation and follow up when required
• Update CTMS and all other project systems with accurate and current site information

Qualifications

• Bachelor Degree in life science nursing or equivalent
• Minimum one year of relevant monitoring or clinical research experience
• Good understanding of GCP ICH and general clinical research processes
• Strong communication skills and ability to build productive site relationships
• High level of organization attention to detail and ability to work independently
• Proficiency in common software and clinical systems

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 27 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 800 professionals, TFS delivers tailored clinical research services in more than 40 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.

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