Job Description

About this role

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.

The Clinical Research Associate (CRA) is responsible for ensuring clinical studies are conducted in accordance with the protocol, ICH-GCP guidelines, and applicable regulatory requirements. This role involves site management and monitoring activities throughout the study lifecycle to ensure patient safety, data quality, and study compliance.

As part of our SRS/FSP team, you will be dedicated to one sponsor, a global pharmaceutical company that is an industry leader within its therapeutic area.

Key Responsibilities

• Perform site monitoring visits, including Site Selection Visits (SSVs), Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), and Close-Out Visits (COVs).
• Ensure investigator sites comply with study protocols, ICH-GCP, sponsor requirements, and local regulations.
• Monitor patient safety, data quality, and study documentation throughout the clinical trial lifecycle.
• Develop and maintain strong relationships with investigators, site staff, and sponsor stakeholders.
• Support site readiness, subject recruitment, and issue resolution to ensure study timelines are met.
• Identify, document, and escalate risks while supporting risk-based monitoring approaches.
• Assist with audit and inspection readiness activities as required.

Qualifications

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
• Minimum 3 years of independent clinical monitoring experience within the pharmaceutical, biotechnology, or CRO industry.
• Strong knowledge of ICH-GCP guidelines and applicable regulatory requirements.
• Experience managing sites from initiation through close-out.
• Excellent communication and relationship-building skills.
• Fluent English, both written and spoken.
• Ability and willingness to travel regularly within the assigned country.
• Valid driving licence.

What We Offer

We provide opportunities for personal and professional growth in a rewarding environment. You will join a team that values collaboration, quality, and making a difference in the lives of patients.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decisions and shape our culture. By aligning on these values, we foster collaboration, innovation, and a shared commitment to excellence. Together, we make a difference.

EU Pay Transparency

Georgia

Salary: Competitive and aligned with local market conditions, based on experience and qualifications, plus applicable benefits.

A Bit More About Us

Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service global CRO, we build solution-driven teams working toward a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries, offering flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.