- Supporting study site selection and qualification;
- Developing and/or reviewing study documents for compliance with local and national clinical study requirements;
- Supporting regulatory submissions and site start-up (including preparation of study materials);
- Monitoring the study throughout its duration (initiation, interim, close-out), which involves visiting the study sites regularly;
- Reviewing study case report forms (CRF) completed by the sites towards the source data (SDR/SDV activities), and validating accurate source documentation to support CRF entries;
- Collaborating with study sites to ensure timely data entry and data cleaning;
- Regular remote monitoring to proactively identify potential risks and/or issues;
- Documenting site visits and issues in applicable reports and follow-up letters to the site;
- Supporting protocol and other study-related site training to ensure compliance and quality;
- Ensuring accurate and up-to-date study documentation (including TMF and study binders);
- Ensuring timely and compliant documentation and reporting to Regulatory Authorities and Ethics Committees/Institutional Review Boards (e.g. adverse event and device deficiency reporting);
- Ensuring compliance with all applicable local and national regulations; GDPR, GCP, company SOPs, study protocols, and relevant manuals.
- Minimum 2 years of experience in a comparable role.
- Fluent in Dutch and English.
- Frequent international travel required.
- Accurate, eye for detail, independent and pro-active attitude.
- Excellent communication skills, able to collaborate and build relationships with people across all levels.
- Bachelor's or master's degree in life sciences or relevant experience
- Knowledge of Good Clinical Practice (ICH, ISO 14155), Data Protection (GDPR) and Clinical Research laws and regulations.
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Clinical Research Associate - 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 migraines. With a focus on ongoing development, we are currently looking for a Clinical Research Associate. You will be part of the clinical team and able to work on clinical studies at various stages. The CRA plays a crucial role in ensuring the successful conduct of clinical trials by maintaining high standards of quality, compliance, and patient safety. You are passionate about clinical research and your dedication ensures our clinical studies are conducted with the highest quality and compliance.
RESPONSIBILITIES
YOUR PROFILE
