Clinical Research Specialist

Description

Our mission is to provide intelligent technology that is friendly, caring and more human.We build AI systems to understand human behavior through wearable sensors. Our technology empowers thousands of patients, clinicians and researchers with real-time human insight, driven by physiological and behavioural biomarkers.We design and develop medical-quality wearable devices aimed to improve people's emotional well-being and save lives. Embrace2, our hero product, is the only wrist-worn seizure monitor cleared by the FDA. We believe in a work environment that fosters autonomy, mastery and purpose. Each employee at Empatica is mentored and supported in their personal and professional development goals. We are a team of passionate people from all over the world bringing high levels of creativity to our everyday work.Watch the recent TEDx talk delivered by our Co-Founder and Chief Scientist Rosalind Picard to learn more about the history of Empatica and what drives our commitment to great work: https://www.ted.com/talks/rosalind_picard_an_ai_smartwatch_that_detects_seizures_and_saves_lives

We build AI systems to understand human health through wearable sensors. Our technology empowers thousands of patients, clinicians and researchers with real-time human insight, driven by physiological and behavioral biomarkers.We are continuously involved in clinical trials for the validation of our devices on new indications for use. We are looking for an experienced clinical research specialist who will help us expanding further opportunities in the clinical study field.

You will:

• Assist in writing, reviewing, and amending clinical study protocols.
• Provide quality-control support as needed including clinical and regulatory documents that will be used for IRB approvals.
• Coordinate clinical trial activities in compliance with federal regulations, GCP guidelines & internal policies.
• Assist site-specific research teams with facilitating enrollment and data collection of subjects through Empatica products.
• Create instructions for use, consent forms, case report forms and other clinical study documents in collaboration with other cross-functional team members.
• Configure study-specific tools to ensure protocol compliance.
• Prepare and process research kits as required.
• Contribute to problem resolution by collaborating with other teams to respond quickly and appropriately to remote users and sites
• Lead and perform clinical data management tasks for assigned studies in accordance with Empatica policies and practices including data collection, review, organization and summarization.
• Efficiently generate routine and ad-hoc reports using internal and external data sources and tools to complete data requests from other team members.
• Assist in the initiation and approval of the building, testing and validation of clinical databases, subsequent changes in clinical databases and data validation activities.
• Adhere to procedures surrounding retention of data, records, and information for clinical studies.
• Read/interpret scientific and medical literature for use in clinical documents and assist in clinical team decisions.
• Provide scientific support of scientific data disclosures (manuscripts, abstracts, conference posters).
• Effectively communicate with management and teammates in all stages of work.

Requirements

The ideal candidate for this role

• Bachelor degree in a scientific discipline
• 2 years of experience in clinical research or having conducted a clinical trial
• Knowledge of good clinical practices
• Knowledge of quality systems and or ISO 13485:2016
• Knowledge of FDA regulations and guidance documents around 510(k) and Clinical Trials
• Knowledge of IRB approval processes
• Good project management skills
• A basic knowledge of data bases and SQL is preferred
• A basic knowledge of scientific software development environments is preferred

The ideal candidate for Empatica

• Is a very quick learner
• Is a very quick learner (it’s not a typo)
• Is fun and easy to work with
• Has an excellent execution mindset
• Is a hard-worker and collaborative
• Has outstanding planning, time management and multitasking skills
• Is focused on quality and excellence
• Is flexible in terms of working time and ability to travel
• Is a problem-solving hustler who can take on any big or small project
• Is passionate about our products and our mission
• Is proficient in English (mother tongue is highly appreciated)

Benefits

• Competitive salary
• We have offices in Milan City Center (where this position is based), Downtown Boston. And every summer, we hold an amazing beach retreat in Sardinia, Italy!
• Free lunch - yes, being in Italy, it's something you should care about!
• Organic fresh fruit
• Your personal MacBook
• Flexible work hours
• Free, superior Italian coffee - of course
• Free cookies, if you deserve them
• Much more...