Clinical Operations Associate
PicnicHealthAbout the role
PicnicHealth is simplifying clinical research with AI, making it faster and cheaper to get new treatments to patients. We’re bringing a patient-centered, AI-first approach to a $100b market otherwise dominated by old-school, services-driven incumbents. We’re 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. We've gained real traction in a conservative industry: 12 of the top 20 pharma companies use PicnicHealth, we've 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, we’re transforming how real-world data powers research through technology and patient-centered design. As our Clinical Operations Associate, you’ll be the operational lead for site-based research—owning 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, you’ll play a role in shaping and evolving how we work with sites, testing new approaches, and refining our playbooks as we grow. You’ll thrive if you’re 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 we’re looking for:
We’re 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. You’re 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. You’re 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.
You’ll 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 Bachelor’s 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 reusab
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