We are a human-centered digital health company that seeks to radically improve brain health outcomes by leveraging cutting-edge technology and machine learning to unlock precision brain health for as many people as possible. While we are steadfastly focused on individuals’ brain health, we believe that meaningful outcomes can only be achieved within an ecosystem of care that actively includes and engages physicians, professionals and caregivers. We are a team of 50+(and rapidly growing!) and are embarking on an exciting period of accelerated growth. We invite collaborative, self-driven and impact-oriented professionals to join our dynamic and fast-growing team.
Does this sound like an innovative & disruptive start-up where you could see yourself? Do the following values resonate with you?
Be A Team
Be Masters of Our Craft
Think Big and Act Bold
If so, please continue reading..
Please note that we are building our hubs across Toronto, Boston & San Diego so those are the preferred locations for this role. Unfortunately, we are not able to provide sponsorship at the moment for any of our openings.
What You’ll Do:
- Ensure protocol compliance and proper data acquisition
- Manage data collection and report adverse events
- Prepare submission of protocol revisions and safety reports to the IRB; ensure annual IRB renewal process
- Resolve data discrepancies
- Responsible for the direct management of the company’s clinical trials
- Help manage relationships with vendor partners and site personnel including CROs, Investigators and Site Coordinators
- Liaise with the Principal Investigators, clinical operations staff and sponsor representatives
- Perform pre-study initiation, interim monitoring and close out visits
- Monitor clinical trials to ensure adherence to Good Clinical Practice, Federal Regulatory Requirements, and study procedures
- Manage sites to ensure proper adherence to protocols and verify data entries
- Develop, review and edit clinical trial related documentation including but not limited to; case report forms, informed consent forms, study specific handbooks, guidelines, and checklists
- Design, develop and/or review study protocols
- Complete and compile all necessary research, documentation, and information to gain appropriate regulatory and ethical committee approval where required
- Provide first level technical support to study sites
- Participate in data analysis
- Bachelor’s degree in biological sciences or a related field.
- Clear understanding of Medical Device Regulations
- Work experience within a contract research organization or medical device/digital health company
- Ability to independently perform all necessary study visits
- Excellent communication and presentation skills
- Ability to build a strong rapport with Principal Investigators and study teams
- Willingness and ability to travel at least 30% of the time
Nice To Haves:
- Prior Clinical Research Associate Experience in medical device / digital health trials
What We Offer:
- As a health and wellness company, an opportunity to have a lasting impact on the way people and communities engage with brain and mental health, and even to affect the prognosis of people’s mental and brain health trajectory(pretty powerful stuff if you ask me!)
- A mission driven environment where all 50 employees(and counting) strive to exemplify our core values every day
- Competitive compensation packages that include an annual discretionary target bonus incentive as well as valuable equity
- Unlimited PTO -- We know this can work both ways, however our leadership team does an excellent job at encouraging people to take PTO
- A peer-to-peer recognition program: Celebrating our employees hard work and success is in our DNA!
- Employee Referral Incentive program
- A robust healthcare package that includes medical, dental & vision benefits as well as a 401(K) program where Linus will match up 6%
Linus Health is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, religion, color, national origin, sexual orientation, gender, gender identity or expression, age, genetic information, disability or any characteristic protected by law. We believe that diversity is critical to the growth of our company and understand the importance of fostering an environment where everyone has a voice. We are also committed to providing reasonable accommodations for candidates with disabilities during the recruiting process. If you are in need of assistance due to a disability, please contact us.