Clinical Research Associate Senior M/W
Il y a 2 mois
About Fortrea
Fortrea is a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas.
Your Responsibilities
- Own all aspects of site management as described in the project plans.
- Ensure the study staff conducting the protocol receive all materials and instructions to safely enter patients into the study.
- Protect study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
- Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by diligently reviewing source documents. Monitor data for missing or implausible entries.
- Perform the required monitoring tasks in an efficient manner, according to SOPs and established guidelines; submit accurate and timely trip reports.
- Review progress of projects and initiate appropriate actions to achieve target objectives.
- Act as a primary contact for clinical trial suppliers and other vendors.
- Own the entire process of Serious Adverse Event (SAE) reporting.
- Generate queries and resolve issues according to data review guidelines on Fortrea or sponsor data management systems.
Requirements
- Solid independent monitoring experience in France as (Senior / Lead) CRA, with a focus on complex clinical trials (phases II and III).
- Proven experience in a variety of therapeutic areas, preferably including oncology.
- Awareness of applicable clinical research regulatory requirements such as local regulations, GCP / ICH, and the French regulatory authorities landscape.
- IT-literate, including Microsoft Word, Excel, PowerPoint, and preferably eTMF solutions such as Veeva Vault.
- 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.
- Excellent communication skills in both French and English - spoken and written - are a must.
About You
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. We strive for diversity and inclusion in the workforce and do not tolerate harassment or discrimination of any kind.
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