Lead Clinical Research Associate - Freelance

About us

TFS Health Science is a global, full-service Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies across all phases of clinical development. As our organization continues to grow, we are seeking an experienced Lead Clinical Research Associate (Lead CRA) to join our team.

Please, keep in mind that this is a Freelance role for approximately 0.2 FTE (6 years).

• Support the Project Manager and oversee all monitoring and site management activities, ensuring compliance with ICH/GCP, SOPs, and protocol requirements.

• Lead, guide, train, and supervise CRAs, providing quality oversight of monitoring activities and proactively identifying operational issues.

• Develop Study Monitoring Plans, Monitoring and Site Training Plans, verification initiatives, and coordinate Study Investigator Meetings.

• Ensure study procedures and expectations align with operational feasibility from study start-up to close-out.

• Local feasibility

• CDA management

• Contracting and site budgeting

• Bachelor’s degree in life sciences, nursing, or equivalent.

• Minimum 3 years of CRA experience, including on-site monitoring.

• Experience in Phase 4 / RWE / Non-Interventional Studies.

• Experience in Oncology;
  Breast Cancer experience is highly desirable.

• Solid knowledge of GCP, ICH guidelines, and regulatory requirements.

• Ability to work independently and within a matrix team on multiple projects.

• Strong organizational skills and excellent written and verbal communication abilities.

• Competency in site management, monitoring, and documentation oversight.

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

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.