Unblinded Clinical Research Associate

1 week geleden

Leiden, Nederland Fortrea Voltijd

If you are a CRA I or CRA II looking to deepen your expertise in investigational product management and gain specialized experience in unblinded clinical operations, this is the perfect next step in your career.

Join a high-impact team where your attention to detail and regulatory knowledge will directly support trial integrity and patient safety. This role offers hands-on collaboration with site pharmacies and supply logistics, opening the door to advanced clinical development opportunities. Step into a critical role that sets you apart in the clinical research field.

**Essential Job Duties**
- Owning all aspects of pharmaceutical site management as described in the project plans.
- Ensuring accurate pharmacy documentation.
- Maintaining investigational medicinal product (IMP) accountability.
- Ensuring blinded and unblinded site staff members can work in a coordinated manner without compromising the blinded monitors.
- Overseeing that IMP supplies are maintained in suitable storage conditions and are accurately reconstituted, dispensed, administered, returned and destroyed.
- Reviewing Case Report Forms (CRF), generating queries and resolving issues in accordance with established data review guidelines on Fortrea or client data management systems.
- Regular eTMF updates.
- Participating in regular team calls.
- Traveling within assigned country (travel is done locally).

**Experience**
- Minimum 6 months of previous monitoring experience in a comparable function (uCRA or CRA), including familiarity with applicable local regulations and authorities.
- Awareness of applicable clinical research regulatory requirements such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH).
- Working knowledge of Microsoft Word, Excel and PowerPoint.
- Effective time management and organizational skills and a keen attention to detail.
- Ability to establish and maintain effective, trustful working relationships with internal and external stakeholders o Business fluency in local language.

**Education/Qualifications/Certifications and Licenses**
- Degree in a relevant field such as life sciences, biology, pharmacology, (veterinarian) medicine, or an equivalent scientific or commercial Higher Vocational education (e.g. study nurse, study coordinator.

Learn more about our EEO & Accommodations request here.

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