Clinical Trial Associate

| San Diego, CA | Hybrid
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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 Real

Be Wise

Be Noble 

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

About You:

Must Haves:

  • 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.

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Technology we use

  • Engineering
  • Product
  • Sales & Marketing
  • People Operations
    • JavascriptLanguages
    • SwiftLanguages
    • TypeScriptLanguages
    • ReactLibraries
    • DockerFrameworks
    • GraphQLFrameworks
    • Node.jsFrameworks
    • React NativeFrameworks
    • TerraformFrameworks
    • PostgreSQLDatabases
    • AWS (Amazon Web Services)Services
    • FigmaDesign
    • IllustratorDesign
    • PhotoshopDesign
    • SketchDesign
    • ConfluenceManagement
    • Google DocsManagement
    • JIRAManagement
    • SmartsheetManagement
    • DocuSignCRM
    • HubSpotCRM
    • LinkedIn SalesNavigatorCRM
    • SalesforceCRM
    • MailgunEmail
    • Google HangoutsCollaboration
    • SlackCollaboration
    • ZoomCollaboration

An Insider's view of Linus Health

What projects are you most excited about?

One of the most exciting projects is our work with the Davos Alzheimer’s Consortium, a partnership between industry, academic, government and healthcare systems around the world. Here, the Linus smartphone research app will be used to bring together digital measures of cognition from up to 1 million participants from cohorts around the world.

Judy

Vice President, Strategic Engagements

What makes someone successful on your team?

Passion – One thing that I find all my teammates have in common is passion for what they do. Whether it's improving the product, or delivering the best experience to our customers, everyone is motivated by the same passion and determination. At Linus Health there is opportunity for success within every department and at every.

Sage

Program Manager, PRD

What unique initiatives do you have that encourage innovation?

An expert clinician knows by the way you’re walking if the pain is in the knee, back or hip. It’s similar for cognitive assessments; in the first few seconds, they know where you are going. Linus is not just “digital health”; we translate the compassionate eye of your best clinician into assessments and algorithms. And we’re only getting started.

Joyce

Vice President, Clinical Development

What projects are you most excited about?

I’m most excited about Linus Health’s exploration of remote and passive assessment technologies — from home-based EEG to eye tracking brain games — that will completely change how individuals keep their brains healthier as we age. Digital brain health is one of the most exciting areas of science and tech advancement happening today.

Sean

Director of Product - Senior Living

What are Linus Health Perks + Benefits

Linus Health Benefits Overview

1. 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.
2. We offer an employee referral incentive program as well
3. Peer to peer recognition program
4. Office Closure - We are a healthcare company, working hard on a mission to disrupt early detection brain health. To help deter and prevent burnout, we are testing a weeklong office shutdown this year from December 24th 2021 - January 3rd 2022
5. Home office stipend
6. Unlimited PTO and 10 paid holidays in 2022

Culture
Open door policy
OKR operational model
Team based strategic planning
Hybrid work model
Flexible work schedule
Remote work program
Diversity
Documented equal pay policy
Mean gender pay gap below 10%
Hiring practices that promote diversity
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability insurance
Dental insurance
Vision insurance
Health insurance
Mental health benefits
To help encourage our employees to reset and recharge when they need it, we have implemented a a "monthly flex day".
Financial & Retirement
401(K)
Employees are eligible to enroll in our 401K plan effective after 1000 hours of employer.
401(K) matching
We will match up to 6%.
Company equity
Performance bonus
Child Care & Parental Leave Benefits
Generous parental leave
Vacation & Time Off Benefits
Unlimited vacation policy
Generous PTO
Not only do we have have an unlimited PTO structure, we encourage employees to take the time when they need it. That message starts from the top!
Paid holidays
Paid sick days
Office Perks
Commuter benefits
Company-sponsored outings
Home-office stipend for remote employees
We will offer a one time stipend to ensure our employees have the remote office setup that they need to be productive.
Professional Development Benefits
Promote from within

Additional Perks + Benefits

We recently implemented a peer to peer recognition program: Celebrating our employees hard work and success is in our DNA!

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