- Providing administrative support to Clinical Affairs;
- Providing administrative support to Medical Affairs and the Chief Medical Officer;
- Collecting, registering, and archiving information and documents per the applicable good clinical practice guidelines for clinical studies;
- Preparing investigator site files, trial master files (TMF), and, if applicable, electronic trial master files (eTMF) for the initiation of participating centers in clinical studies;
- Maintaining the complete documentation for the studies assigned and ensuring all study documentation is up to date;
- Performing periodic review of study files for completeness;
- Assisting with preparation, handling, and distribution of clinical trial supplies and maintenance of shipping information;
- Supporting regulatory submissions and site start-up;
- Acting as a central contact for the Clinical Affairs team for designated project communications, correspondence, and associated documentation.
- Assisting in submissions of the study to regulatory authorities and ethics committees.
- May support CRA to perform clinical data review query creation and query resolution upon completion of required training.
- Minimum 2 years of experience in a comparable role;
- Accurate, eye for detail, independent and pro-active attitude;
- Excellent communication skills, able to collaborate and build relationships with people across all levels;
- Fluent in English;
- Knowledge of Good Clinical Practice (ICH, ISO 14155), Data Protection (GDPR) and Clinical Research laws and regulations.
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Clinical Trial Assistant - Eindhoven, Nederland - Salvia BioElectronics
Beschrijving
ABOUT US
Salvia BioElectronics is a medical device company pioneering neuromodulation therapies for migraine. Salvia's unique, paper-thin implant is designed to reduce the frequency and intensity of migraine attacks by delivering gentle electrical pulses to the nerves associated with the condition. The company is currently in the clinical stage of development. In addition, Salvia is considering potential opportunities the device creates for the treatment of cluster headache and other neurological disorders. Salvia has received the Breakthrough Device Designation from the United States Food and Drug Administration (FDA), which facilitates expedited market access for devices that treat life-threatening or irreversibly debilitating conditions.
THE CHALLENGE
Salvia is a fast-growing and dynamic company; we are driven to make a difference for people living with severe migraine. With a focus on ongoing development, we are currently looking for a Clinical Trial Assistant. You will be part of the clinical team and able to work on clinical studies at various stages. The CTA is responsible for operational and administrative support throughout a clinical study. You work with great attention to detail; you embrace organization and dedication, and you have a passion for clinical research.
RESPONSIBILITIES
YOUR PROFILE
