[Hiring] Lead Clinical Research Associate @TFS HealthScience

Role Description

This role involves overseeing clinical research activities as a Lead Clinical Research Associate (Lead CRA).

• 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

Qualifications

• 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.

Benefits

• Competitive compensation package
• Comprehensive benefits
• Opportunity for personal and professional growth in a rewarding environment

Company Description

TFS HealthScience is a global, full-service Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies across all phases of clinical development.

• Founded over 27 years ago in Sweden, in the city of Lund.
• Builds solution-driven teams working towards a healthier future.
• Brings together over 800 professionals delivering tailored clinical research services in more than 40 countries.
• Offers flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.
• Core values include Trust, Quality, Passion, Flexibility, and Sustainability.