Clinical Operations Associate
Clinical Operations Associate
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$ 100 - 130
1 Vacancy
Job Description
PicnicHealth is simplifying clinical research with AI making it faster and cheaper to get new treatments to patients. Were bringing a patient-centered AI-first approach to a $100b market otherwise dominated by old-school services-driven incumbents. Were creating a streamlined operating system for clinical research built on top of our AI for medical record data in trials and a personal health assistant that keeps patients engaged (NPS 76).
Founded in 2014 PicnicHealth has raised over $100 million from investors including YC Amplify Partners Felicis Ventures and B Capital Group. Our business running observational studies more than doubled last year and we expect to grow even faster this year. Weve gained real traction in a conservative industry: 12 of the top 20 pharma companies use PicnicHealth weve got 60 publications across 40 disease areas and we just had our first FDA approval that included our data in the submission.
The Opportunity
At PicnicHealth were transforming how real-world data powers research through technology and patient-centered design. As our Clinical Operations Associate youll be the operational lead for site-based researchowning the day-to-day execution of startup regulatory submissions onboarding and ongoing support across a portfolio of observational and low-interventional studies. At the same time youll play a role in shaping and evolving how we work with sites testing new approaches and refining our playbooks as we grow. Youll thrive if youre excited to roll up your sleeves to get the work done while also helping us figure out better tech-forward ways of doing it.
What were looking for:
Were looking for a self-starter that thrives in a dynamic start-up environment where processes evolve rapidly and who can take full ownership of outcomes. Youre energized by navigating ambiguity in the complex world of observational research and you know how to bring clarity for others while keeping projects moving. You balance speed with quality delivering work that meets high standards even under tight timelines. Youre comfortable juggling multiple priorities and you know when to zoom out to anticipate risks and when to dive into the details to unblock execution. Most of all you bring a collaborative mindset -building trust with sites sponsors and teammates - while holding yourself accountable for results.
Over the next 12 months you will be focused on:
- Centralizing site operations: Build and own scalable workflows for site startup (CDA/feasibility surveys selection contracting budgeting and IRB submissions).
- Streamlining onboarding: Lead creation of training materials scripts SOPs and study one-pagers; ensure every site understands objectives ICFs workflows and the PicnicHealth platform.
- Regulatory execution: Manage IRB submissions amendments and continuing reviews; track documentation in eTMF; own compliance handoffs.
- Ongoing site management: Conduct monthly check-ins oversee site payment processes distribute newsletters and ensure site and stakeholder engagement across the study lifecycle.
- Cross-functional coordination with influence: Collaborate with Project Managers Recruitment Managers Product and Delivery Leadership to operationalize observational studies at scale.
- Study closeout: Lead final site communications regulatory wrap-up and offboarding to ensure timely compliant closure.
- Drive innovation in site operations: Develop and test tech-forward approaches to site engagement pushing creativity in how we deliver consistently and efficiently with quality.
- Leverage AI in a historically low-tech space: Apply AI to site workflows in a part of the industry that has historically been underpowered by technology.
Youll be successful if you:
- Bring 5 years of clinical research operations experience with at least 2 years in site-facing roles (observational or non-interventional research strongly preferred).
- Have hands-on experience with site startup regulatory/IRB submissions and ongoing site management.
- Hold a Bachelors degree in life sciences public health nursing or a related field
- Operate with high autonomy and minimal supervision while maintaining exceptional standards for quality and compliance backed by strong expertise in Good Clinical Practice (GCP) HIPAA and site compliance workflows.
- Are adept at cross-functional coordination across delivery regulatory and quality and product teams.
- Excel in fast-paced scaling health-tech environments with a mindset for building reusable playbooks and processes.
- Possess excellent written and verbal communication skills with the ability to influence adapt and build trust with sites sponsors and internal stakeholders.
We expect all team members to be motivated to be amazing in their roles and ultimately to move the PicnicHealth mission forward.
Why will PicnicHealth win in Clinical Research
Trials are a major bottleneck in drug development and the promising advancements in biotech cannot achieve their full potential unless clinical research becomes more effective. The industry runs on outdated technology and manual processes. Research sites (hospitals academic centers doctors offices) are a major bottleneck and contract research organizations (CROs) spend most of their time wrangling sites and cobbling together vendor software.
PicnicHealth has built technology that uniquely positions us to run faster cheaper and more flexible studies without requiring sites:
- PicnicAI (trained on 350M clinician annotations over 100k patient records) is the only system that can effectively access and structure all participant EMR data trials need
- Our AI health assistant (NPS of 66 in 2024) guides participants through study activities and enables most to be done at home
- Were an integrated solution virtual site CRO and software platform with AI built in from the ground up initially focusing on observational research.
The other perks & benefits you get when you work at PicnicHealth
We pay competitive salaries. Everyone on the team is an owner: all full time employees get competitive equity.
Target Base Salary Range: $100K -$130K
The base salary PicnicHealth offers may vary depending upon the scope complexity and autonomy of the position and on the candidates job-related knowledge skills and experience.
Were a remote first company with teammates spread across the US. We support in-person gatherings including co-working spaces and multi-day onsites to build connections and move forward strategic initiatives. Expect to travel 2-4 times a year. For our team members in the Bay Area who prefer to work in person we can offer a hybrid set up to work from the SF office on a flexible schedule.
You also get:
- Comprehensive benefits including above market Health Dental Vision
- Family friendly environment
- Flexible time off
- 401k plan
- Free PicnicHealth account
- Equipment and internet funds for home office set up
- Wellness Stipend
PicnicHealth is committed to promoting an inclusive work environment free of discrimination and harassment. We value a diverse and balanced team where everyone can belong.
Required Experience:
IC
Employment Type
Full Time
