Clinical Research Associate

TFS HealthScience; Basel; Vor Ort; CHF 100’000 - 130’000; Vollzeit

Zusammenfassung

A leading global CRO, TFS HealthScience, is hiring a Clinical Research Associate in Basel, Switzerland. The role involves ensuring compliance with ICH-GCP and managing site activities throughout clinical trials. Candidates should have a Bachelor's degree and 5+ years of clinical monitoring experience, along with fluency in English and German.

Leistungen

Professional development opportunities

Quality-driven culture

Qualifikationen

• Minimum 5 years of clinical monitoring experience in CRO, biotech or pharmacy.
• Fluency in English and German is required.
• Solid understanding of ICH-GCP and Swiss regulations.

Aufgaben

• Conduct regulatory and ethics submissions including amendments.
• Perform on-site and remote monitoring for protocol compliance.
• Maintain eTMF documentation and oversee site closeout activities.

Kenntnisse

Interpersonal skills

Regulatory compliance knowledge

Project management

Ausbildung

Bachelor's degree in Life Sciences, Nursing, Pharmacy or equivalent

Tools

CTMS

eTMF systems

Remote monitoring tools

Jobbeschreibung

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) dedicated to partnering with biotechnology and pharmaceutical companies throughout their entire clinical development journey. With expertise in full-service capabilities, resourcing, and Functional Service Provider (FSP) solutions, we’re currently seeking a skilled Clinical Research Associate (CRA) contractor to join our team in Switzerland .

About the Role

As a Clinical Research Associate at TFS HealthScience, you’ll be part of our high-performing SRS / FSP team, working exclusively with a leading global pharmaceutical or biotech sponsor. In this vital role, you will ensure clinical trials are conducted according to protocol, ICH-GCP, and Swiss regulatory requirements — from site activation through closeout.

Key Responsibilities

• Submission & Amendment Support : Assist with regulatory and ethics committee submissions, including amendments.
• Regulatory Reporting : Manage regular safety reporting and other required submissions to Swiss ethics committees and Swissmedic.
• Pre-activation & SIV Support : Contribute to site readiness and conduct / support Site Initiation Visits (SIVs).
• Monitoring & Site Management : Perform on-site and remote monitoring to ensure data integrity, subject safety, and protocol compliance.
• Documentation & Closeout : Maintain eTMF documentation and oversee site closeout activities in compliance with Swiss regulations and sponsor SOPs.

Qualifications

• Experience : Minimum of 5 years of independent clinical monitoring experience, preferably within Switzerland and within a CRO, biotech, or pharmaceutical company.
• Education : Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or equivalent.
• Knowledge : Solid understanding of ICH-GCP, Swiss regulatory environment
• Technical Skills : Familiarity with CTMS, eTMF systems, and remote monitoring tools.
• Language : Fluency in English and Germanisrequired
• Communication : Strong interpersonal skills, with the ability to collaborate effectively with investigators and sponsor representatives.

What We Offer

• Opportunity to collaborate with a world-class sponsor on cutting-edge research
• A supportive, quality-driven culture with focus on professional development

Why TFS HealthScience?

Founded over 27 years ago in Lund, Sweden, TFS HealthScience is now a global CRO with more than 800 employees across over 40 countries. We specialize in providing tailored clinical development and strategic resourcing solutions across key therapeutic areas such as Dermatology, Neuroscience, Oncology, and Ophthalmology.

Our values — Trust, Quality, Passion, Flexibility, and Sustainability — are at the heart of how we work, both internally and with our clients. They guide our decisions and help us build long-term relationships rooted in mutual respect and shared purpose.

Make a Difference with Us

Join TFS HealthScience and be part of a dedicated team that’s driving medical innovation and improving lives worldwide.

Apply now to take the next step in your clinical research career in Switzerland.