Senior Clinical Research Associate

vor 1 Monat

Winterthur, 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 (FSP) solutions, we’re looking for a talented Clinical Research Associate (CRA) contractor to join our team in Switzerland.

About the Role

As a Senior Clinical Research Associate with TFS HealthScience, you will be a vital part of our SRS/FSP team, working exclusively with a world-renowned global pharmaceutical/biotech sponsor. You will play a crucial role in ensuring the quality and integrity of clinical trials, driving them forward from start to finish.

Key Responsibilities

  1. Submission & Amendment Support: Assist with initial and ongoing submissions, including amendments to ethics committees.
  2. Regulatory Reporting: Manage periodic reporting to ethics committees, including the reporting of safety events.
  3. Pre-activation & SIV Support: Contribute to site pre-activation activities and support Site Initiation Visits (SIVs).
  4. Monitoring & Site Management: Conduct both onsite monitoring and periodic central monitoring to ensure trial integrity; manage site relationships and processes.
  5. Documentation & Closeout: Maintain the eTMF (electronic Trial Master File) and lead closeout visits, ensuring compliance and completeness.

Qualifications

  1. Experience: Minimum of 5 years of clinical monitoring experience within a CRO, biotech, or pharmaceutical environment.
  2. Education: A Bachelor’s degree in a related field (Life Sciences, Nursing, etc.).
  3. Regulatory Knowledge: Strong understanding of ICH-GCP guidelines and regulatory requirements in Switzerland.
  4. Technical Skills: Proficiency in clinical trial management systems (CTMS) and eTMF platforms.
  5. Communication: Excellent written and verbal communication skills with the ability to interact effectively with site staff and sponsor representatives.

What We Offer

We provide a competitive compensation package, comprehensive benefits, and the opportunity for both personal and professional growth within a supportive and rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a real difference in the lives of patients.

Make a Difference with Us

Join TFS HealthScience and be part of a team that’s making a real impact on global health. Apply now to take the next step in your career

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