Clinical Research Associate – Il Student Position (Part-Time)

• Provide operational and scientific support for global clinical validation and research studies under the guidance of the Director of Clinical & Scientific Affairs. Key responsibilities include supporting protocol development, study reports, scientific conference deliverables (posters and presentations), and regulatory documentation while collaborating cross-functionally to ensure rigorous and timely study execution.

• Proactively contributes to clinical study processes by supporting the execution and tracking of clinical operations, ensuring compliance with company SOPs, ICH-GCP guidelines, regulatory requirements, and patient safety standards.

• Assists in developing and writing clinical study protocols, study plans, Ethics/IRB submission packages, CRFs, and clinical study reports.

• Facilitates training for clinical study teams according to study protocols and maintains strong relationships with investigators and external experts to support effective project delivery.

• Supports data quality initiatives and helps implement activities required for timely, high-quality deliverables (e.g., collaborating with statisticians and data managers, participating in data review).

• Analyzes, interprets, and presents clinical study results to internal and external stakeholders, including contributing to scientific peer-reviewed publications.

Requirements:

• Graduate student in the advanced stages of PhD (optional MD) in Life Sciences, Biomedical Engineering, or a related discipline.

• Previous experience in conducting medical device or IVD clinical studies – Significant advantage.

• Knowledge of oncology, pathology, medical device/IVD clinical development, and a deep understanding of molecular pathways and biopharma development in oncology - Preferred.

• Experience contributing to research planning, study design, clinical operations, data handling, biostatistics, scientific posters, presentations, and manuscript drafting.

• Demonstrated ability to work both independently and collaboratively to execute complex study plans, protocols, methodologies, and study timelines under general guidance.

• Solid understanding of the clinical operations value chain, with a proven track record of supporting study planning, execution, data management, and clinical study reporting

*We are an equal opportunity employer and committed to creating a friendly, inclusive environment that is a pleasure to work in, and where there is an unbiased acceptance of others.