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.
About this role
As a Clinical Research Associate, you will support the initiation, on-site and remote monitoring, and close-out of clinical trial sites, ensuring participant safety, data integrity, and compliance with ICH-GCP, SOPs, and regulatory requirements.
Key Responsibilities:
* Monitor clinical trials on-site and remotely in line with TFS/sponsor SOPs, ICH-GCP, and regulations.
* Ensure subject safety, protocol adherence, informed consent compliance, and data accuracy.
* Review source documentation and CRFs and verify Investigational Product management.
* Document monitoring activities in timely, accurate reports and escalate issues when needed.
* Maintain ISF and deliver required documents to TMF/eTMF; update CTMS and project systems.
* Support audits, inspections, and clinical supply management (as applicable).
Qualifications:
* Bachelor’s degree in life sciences, nursing, or equivalent; 1+ year of relevant clinical experience.
* Solid understanding of medical terminology, GCP, ICH guidelines, and regulatory requirements.
* Strong communication, organization, and time-management skills; tech-savvy and detail-oriented.
* Ability to work independently and collaboratively in a matrix team environment.
* Fluent in English; flexible, proactive, analytical, and collaborative mindset.
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 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. Our values shape our culture and work ethic. They reflect what we stand for and guide our organization.
#Together we make a difference