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 Provider (FSP) solutions.

Join Our Team as a Senior Clinical Research Associate

About This Role

As part of our Clinical Development Services, Internal Medicine & Neurology team, you will work alongside passionate and innovative professionals to support the successful delivery of clinical research programs. This opportunity offers the chance to contribute to cutting-edge rare disease and gene therapy studies while collaborating with experienced global project teams.

The Senior Clinical Research Associate (SCRA) is responsible for the initiation, monitoring, management, and close-out of study sites in accordance with protocol requirements, ICH-GCP guidelines, company SOPs, and applicable regulatory requirements. The SCRA serves as a key point of contact for investigative sites and plays a critical role in ensuring patient safety, data quality, and study integrity.

This freelance assignment requires a Senior CRA available at approximately 0.5 FTE, with potential to increase to 0.8 FTE during periods of higher study activity.

Key Responsibilities

• Perform site qualification, initiation, routine monitoring, and close-out visits across assigned clinical trials.

• Ensure protocol compliance, data quality, patient safety, and regulatory adherence at investigative sites.

• Conduct remote and on-site monitoring activities, including source data verification and risk-based monitoring tasks.

• Build and maintain effective relationships with investigators, study coordinators, and site personnel.

• Identify, document, and escalate site issues while driving timely resolution and mitigation plans.

• Contribute to study deliverables through accurate reporting, site management activities, and cross-functional collaboration.

Qualifications

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

• Minimum 5 years of independent clinical monitoring experience within the pharmaceutical, biotechnology, or CRO industry.

• Strong knowledge of ICH-GCP, clinical trial regulations, and monitoring best practices.

• Experience in rare disease, neurology, or gene therapy studies is highly desirable.

• Fluency in French and English, both written and spoken.

• Ability and willingness to travel to investigative sites within France and neighboring countries as required.

What We Offer

We provide a competitive compensation package, comprehensive benefits, and opportunities for professional growth within a collaborative and rewarding environment. You will join a team that values innovation, flexibility, quality, and a shared commitment to improving patient outcomes.

A Bit More About Us

Our journey began over 25 years ago in Sweden, in the city of Lund. As a global CRO with the ultimate goal of ensuring patients' safety and well-being, we provide biotechnology and pharmaceutical companies with tailored clinical development solutions. We currently operate in 17 countries across Europe, North America, Asia Pacific, and the Middle East.

Our core values of Trust, Quality, Flexibility, and Passion are what make TFS HealthScience the successful company it is today. These values shape our culture, guide our decisions, and define how we work together to deliver excellence for our clients and patients.

#TogetherWeMakeADifference