Senior Clinical Research Associate

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.

Join Our Team as a Senior Clinical Research Associate (Freelance, 1.0 FTE)

About this role

As part of our Clinical Development Services (CDS) team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.

The Senior Clinical Research Associate (SCRA) is responsible for the initiation, on-site and/or remote monitoring, and close out of study sites during study conduct in accordance with company policies, SOPs, GCP, ICH guidelines, sponsor requirements, and applicable regulatory regulations. The SCRA will also provide guidance and support within project teams and may contribute to broader project-related activities.

Key Responsibilities:

• Monitor on-site and remotely clinical trials in accordance with TFS and/or sponsor Standard Operating Procedures, GCP and ICH guidelines, and applicable regulatory requirements. Perform all required monitoring activities to ensure subject safety, data integrity, and quality.

• Verify the protection of study participants through informed consent procedures and protocol compliance in accordance with regulatory requirements.

• Review CRFs (electronic or paper) and subject source documentation for validity, completeness, and accuracy and verify proper management and accountability of Investigational Product.

• Prepare timely monitoring visit reports, document findings and corrective actions, update required tracking systems, and escalate issues as appropriate.

• Ensure Investigator Site Files (ISF), eTMF documentation, CTMS records, and other study documentation are maintained in accordance with GCP, ICH guidelines, and regulatory requirements.

• Support project-related activities including review of monitoring reports, site assessment visits, audit and inspection readiness, mentoring of CRAs, and other activities as required.

Qualifications:

• Bachelor's Degree, preferably in Life Sciences, Nursing, or equivalent.

• More than 3 years of experience as a Clinical Research Associate, including significant on-site monitoring experience.

• Strong understanding of Good Clinical Practice (GCP), ICH guidelines, and applicable regulatory requirements.

• Experience managing clinical sites through initiation, monitoring, and close-out phases of clinical trials.

• Excellent written and verbal communication skills, strong organizational abilities, and fluency in English.

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 30 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 600 professionals, TFS delivers tailored clinical research services in more than 50 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.