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Clinical Research Associate
Il y a 2 mois
About Withings
Withings is a leading innovator in clinical-grade smart health devices, dedicated to providing accurate, real-world data to innovators in the healthcare industry.
Job Summary
We are seeking a Clinical Research Associate to join our Clinical Operations team, responsible for participating in the design phase of clinical investigations, assisting in the development of clinical trial protocols, and ensuring regulatory compliance.
Key Responsibilities
- Participate actively in the design phase of clinical investigations by becoming an expert on the device to be tested.
- Assist in the development of clinical trial protocols for studies sponsored by Withings, ensuring alignment with regulatory and ethical guidelines.
- Stay updated on regulatory requirements and assist in preparation of regulatory package.
- Perform Site Selection visits to evaluate if the site is suitable for the study conduction.
- Conduct site initiation visits to ensure sites are adequately equipped and trained for data collection and management.
- Oversee the day-to-day data consistency check monitoring for ongoing clinical studies.
- Collaborate with study sites to identify and recruit eligible participants for the trials, ensuring study protocol compliance.
- Conduct regular site visits to monitor the progress of Withings trials, ensuring adherence to protocols and data collection standards.
- Oversee the collection, management, and quality control of e-health data, including remote monitoring and patient-reported outcomes.
- Participate in design, development, and execution of databases to collect data for clinical research projects.
- Assist in the preparation of clinical trial reports.
- Collaborate with data analysts and statisticians to facilitate data analysis for Withings sponsored studies.
- Ensure that trials are conducted in accordance with Good Clinical Practice (GCP) and all relevant Withings standards.
- Foster effective collaboration with cross-functional teams to ensure successful e-health trial implementation.
Requirements
- A minimum of a BA or BS degree in Life Sciences, or related scientific field (or equivalent experience) is required with an additional CRA certification.
- 2 years' successful experience in clinical research within biotech, pharma or CRO industry is preferred.
- Regulatory compliance, knowledge of pharmaceutical regulations, good clinical practices, and clinical trial methodology.
- Familiarity with electronic data capture (EDC) systems and e-PRO (patient-reported outcomes) tools.
- You are a dynamic problem-solver with excellent communication skills and a relentless attention to detail.
What We Offer
- Join an international company with teams based in multiple locations.
- Participate in the continuous improvement of our products and services.
- Benefit from numerous advantages, including stock options, smartphone and computer of your choice, discounts for cultural and sports activities, company restaurant, and more.
- Participate in the Withings Med Academy by attending lectures by healthcare professionals to strengthen your knowledge in the medical field.
- Collaborate with passionate colleagues and celebrate each of our successes together.
About Us
We know that diversity, equity and inclusivity are paramount to fostering innovation. We rely on the unique skill sets, life experiences and perspectives of each team member to accomplish our mission—creating technology that people love, to make better health part of everyday life.
