Clinical Trial Associate at Linus Health
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 75+(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:
- Assist in planning, coordinating, and overseeing clinical study set-up, active study management, data analysis and reporting, and close-down for one or more clinical studies
- Assist with all clinical study guidance documents, including, but not limited to: clinical elements of the Investigator Brochure study protocol, ICF, and the various study plans, e.g., study manual, data management plan, regulatory plan, safety plan, statistical analysis plan
- Participate in the preparation and review of SOPs and other essential documents
- Assist with preparing and delivering study team protocol-specific training materials
- Assist with budget management
- Coordinate cross-functional project-related activities
- Develop and manage study trackers and provide metrics as needed
- Organize and prepare study files related to study tracking and reporting and submit to the Trial Master File within established guidelines
- Ensure inspection readiness and provide support to sites to prepare for clinical audits/inspections.
- Ensure documentation is completed in accordance with GCP regulatory requirements and is consistent with the study protocols
- May need to assist in monitoring visits with investigative sites to confirm that the protocol is being followed and that the data is being recorded in a timely manner
- BS/BA degree
- 2+ years of experience working in clinical operations with keen attention to detail and the ability to work independently
- Knowledge of medical device and software, clinical operation processes and documentation including study start-up procedures, maintenance phase, and study closeout procedures
- Knowledge and implementation of the processes involved in clinical studies following Good Clinical Practice (GCP) and ICH guidelines
- Experience with eTMF; ability to directly apply essential document knowledge to file documents
- Effective communication, organizational and interpersonal/team skills
Nice To Haves:
- Medical Device or digital health experience
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 75 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 sincere and deep appreciation for the importance of mental health. We have recently implemented a “monthly flex day” where employees are encouraged to take time away from work to rest, recharge & reset.
- 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.