Clinical Research Associate

vor 11 Stunden

Zürich, Schweiz TFS HealthScience Vollzeit

**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).
- **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 German is required
- **Communication**: Strong interpersonal skills, with the ability to collaborate effectively with investigators and sponsor representatives.

**What We Offer**:

- Flexible contractor engagement
- 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.

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