Role Description The Clinical Refill Coordinator, RN plays a vital support role within our Obesity Medicine care team. You will manage the day-to-day clinical workflow around obesity medication refills, serve as a knowledgeable first point of contact for member clinical questions, and help ensure continuity of care across a high-volume patient population. This role is ideal for a clinically confident RN who thrives in a fast-paced, protocol-driven environment and is passionate about obesity medicine. - Refill management: Review and process refill requests for GLP-1 agonists and other obesity medications per standing orders and clinical protocols; escalate to prescribing providers as appropriate. - Member clinical support: Respond to inbound member inquiries via phone and secure messaging regarding medication side effects, dosing questions, injection technique, and general weight management guidance. - Care team collaboration: Partner closely with physicians, NPs, and PAs to flag clinical concerns, coordinate prior authorizations, and support seamless handoffs for members requiring elevated care. - Documentation: Maintain accurate, timely records of all member interactions and clinical decisions in the EHR in accordance with nursing standards and organizational policies. Qualifications - Active RN license under the Nurse Licensure Compact (NLC) - 2+ years clinical nursing experience - Experience with obesity medications (GLP-1s, Qsymia, Contrave, etc.) - Comfort with high-volume phone and messaging workflows - Proficiency with EHR platforms (Healthie a plus) Benefits - Fully remote environment – work from anywhere while maintaining meaningful collaboration with a distributed team - Comprehensive health benefits – medical, dental, and vision coverage to support you and your family - Paid time off – 2 weeks of PTO to rest, recharge, and take the time you need - Flexible floating holiday – one additional day each year to celebrate what matters most to you - Paid sick leave – 5 sick days so you can prioritize your health when needed - 11 paid company holidays throughout the year - 401(k) retirement plan to help you invest in your future - Healthcare and Dependent Care FSA options for additional tax-advantaged savings

Role Description The Senior Clinical Study Manager is responsible for clinical trial execution within the US and EU regions for Leica Biosystems. This role will specifically support Leica Biosystems, an operating company of Danaher Diagnostics. As the Senior Clinical Study Manager, you will independently lead end-to-end study planning and operational delivery, ensuring alignment with regulatory requirements, timelines, and quality standards. You will serve as the central point of accountability for study execution, collaborating cross-functionally and with external partners to drive progress, resolve issues, and achieve critical program milestones. This position is part of the Clinical Development team and will report to the Senior Manager, Clinical Programs and will be a remote role. In this role, you will have the opportunity to: - Provide strategic oversight into the operational planning and execution of complex programs and individual In Vitro Diagnostics (IVD) clinical studies from concept to close-out, ensuring adherence to protocols, Good Clinical Practice (GCP), and regulatory requirements. - Oversee site and vendor selection and management activities for clinical trial services, ensuring contracts, scope of work, and performance metrics align with study objectives and Standard Operating Procedures (SOPs). - Develop and implement comprehensive study operational plans, including timelines, budgets, resource allocation, and risk mitigation strategies to ensure efficient and successful study conduct. - Establish and maintain robust communication channels with investigators, site staff, internal stakeholders, and external partners to facilitate smooth study progress and timely issue resolution. - Conduct regular reviews of clinical study data, site monitoring reports, and operational metrics to identify trends, ensure data integrity, and proactively address any performance or quality issues. - Act as a key point of contact and actively support internal and external audits and regulatory inspections, ensuring timely provision of documentation and addressing any findings or observations. Qualifications - Bachelor’s degree in Life Sciences, Healthcare, or a related field with 8+ years work experience or Master’s degree with 6+ years of related experience. - Demonstrated comprehensive understanding of regulatory requirements, study execution, data integrity, strategic and tactical planning, written and verbal communication, and project management principles for clinical studies. - Experience working with all levels of management and consulting with key internal business stakeholders, with the proven ability to influence. - Direct experience with Immunohistochemistry (IHC) operational workflows. - Ability to work in a global environment. Requirements - Experience in study designs for in vitro diagnostic technologies (IVD) is highly preferred, specifically for Companion Diagnostics (CDx), Computational Pathology, Immunohistochemistry (IHC) and In Situ Hybridization (ISH). - Advanced degree in Science, Healthcare, or Regulatory/Clinical Affairs. - Professional certification in Clinical Research (e.g., SoCRA, ACRP). Benefits - Comprehensive package of benefits including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees. - Bonus/incentive pay eligibility.

Role Description The Clinical Trial Manager (CTM) II is responsible for the execution of operational activities for a study or group of studies at a regional level or within a small group of countries, including tracking progress and quality at clinical sites. The CTM II will lead the monitoring team and associated deliverables, including the clinical monitoring plan, site visit reports, etc. In addition, the CTM II works to ensure clinical trial timelines are being met and communicated to the Project Leader/Global Clinical Project Manager. The CTM II will independently oversee site management and site monitoring activities. Responsibilities - Possesses detailed knowledge of the study/protocol and its associated activities and timelines, leverages operational expertise to design operational strategy for trial execution. - Provides mentoring, training, and independent oversight for in-house Clinical Research Associates (CRAs), CRAs, and site management staff on assigned projects. - Leads operational implementation of a study, including management of tasks and oversight of clinical operations activities specific to each phase of the study lifecycle in accordance with corporate and project-level Standard Operating Procedures, study plans and any client/sponsor requirements or guidelines. - Establishes and maintains strong working relationships with clients, vendors, and internal collaborators. Communicates with internal and external collaborators regarding status of tasks and updates and is responsible for communication of status of activities to internal teams. - Under the guidance of the Project Leader/Global Clinical Project Manager, serves as the client/sponsor-facing point of contact for operational activities as outlined in the study’s Communication Plan. - Leads internal and external operational study calls and meetings, participates in other calls as required. - Escalates issues or concerns regarding study activities to line management and the department leadership as needed. - Leads the development and review of key study plans such as the Manual of Procedures (MOP), Clinical Monitoring Plan (CMP), Standard Operating Procedures (SOPs), pharmacy/lab manuals, TMF plan, etc. Provides operational review of the protocol if applicable. - Leads the development and review of key templates such as master informed consent form(s) and other participant-facing documents, site training materials, annotated report for each visit type conducted for the study, monitoring visit checklists, monitoring correspondence documents, etc. - Responsible for ensuring site document currency and ethics approvals, as applicable. - Ensures study timelines and deliverables are met by CRA staff, including, but not limited to, development of the clinical monitoring plan per the Statement of Work (SOW), evaluation of the risk-based monitoring strategy, monitoring visit frequency, monitoring visit report submission/approval timelines, study data collection timelines, and the annotated reports per the project SOW and/or Emmes SOPs. - Continuously evaluates current operational practices and recommends process improvements to ensure continued compliance with regulatory requirements and industry best practices. - Develops and maintains metrics related to site assessments, feasibility and selection, site activation and close out activities. - Tracks and reports on site performance metrics and quality. Stays up to date on overall study progress at the site(s) and proactively identifies and escalates risk (e.g. recruitment rates, missing data, investigational product inventory and expiration, protocol compliance, safety reporting, regulatory issues, etc.) while providing risk mitigation strategies. - Remains informed of data system progress and data management activities; may serve in a consultative role as it relates to the study protocol and operational guidelines, report development, data collection requirements, eCRF design, etc. - Maintains frequent communication with the safety/medical monitor to ensure adequate safety reporting information is included in key study documents (e.g., protocol, informed consent form) and that safety event reporting is occurring as required. Tracks reporting and follow-up of Adverse Events, Serious Adverse Events, and Suspected/Unexpected Adverse Events. - Responsible for study-level supplies and investigational product/device accountability, including coordination with vendors as applicable. - Tracks documentation and archiving of study documents. - Conducts observational, training, and co-monitoring visits with CRAs as applicable. - Assists with bid defense preparation and conduct and in the RFP/proposal process. - May assist with DSMB/DMC coordination and management. - Other duties as assigned. Qualifications - Bachelor's or a master’s degree, preferably in a science related field. - Typically possesses at least 7-8 years of relevant clinical research experience, including time as a CRA or in a clinical operations coordinating/leadership role. - Excellent team building and interpersonal skills. - Excellent organizational and analytical skills. - Excellent verbal and written communication skills. - Excellent ability to prioritize and handle multiple tasks. - Ability to work independently, as well as in a complex team environment. - Proficient with MS Office Suite. - Excellent computer and organizational skills. - High attention to detail required. - Ability to work on varying projects and exercise critical thinking. - Self-starter who can work independently and a team player who can work cross functionally with limited oversight. - Knowledgeable in clinical research operations, including interpretation and implementation of country-specific regulations/ICH guidelines, as required. - Demonstrated problem-solving skills, self-motivated, and adaptable to a dynamic environment. - Knowledgeable in prioritization, problem-solving, organization, critical thinking, decision-making, time management, and planning activities. - Ability to collaborate with internal and external colleagues and work well in a team-oriented setting. Benefits - Flexible Approved Time Off. - Tuition Reimbursement. - 401k Retirement Plan. - Work From Home Anywhere in the US. - Maternal/Paternal Leave. - Casual Dress Code & Work Environment.

Role Description We are looking for a Clinical Lead to own the quality and safety layer for Fabric's Medical Intelligence Team (MIT), the team that builds the clinical content, algorithms, and LLM-driven protocols at the heart of our platform. Your job is to make sure all of it meets a rigorous, evidence-based clinical bar before it reaches a patient or a clinician. This is a hands-on individual contributor role for a licensed clinician who has done formal clinical quality work and wants to define what quality looks like for AI-driven care. You will build the validation framework, set the evidence standard, run the review cadence, and be the clinical voice that says "this is safe to ship" or "this goes back." What You'll Do - Clinical Logic Creation: Partner closely with Medical Intelligence Team staff to outline necessary questions, reference sources, first line treatments for predicted diagnoses, appropriate triage routing for particular answers, and patient education drafts. - Clinical AI Creation and Governance: Partner closely with medical intelligence, product, and engineering to develop AI algorithms and quality assurance processes that ensure the Fabric product suite is addressing medicine's Quadruple Aim. - Clinical Oversight: Provide first-pass reviews of clinical logic, safety concerns from safety audits, and other clinical decision-making documents. Present findings and recommendations with evidence-based support to the next most senior medical leader for review, edits, and implementation, as appropriate. - Technical Expertise: Become proficient in the use of LLM and other AI tools to improve both the Medical Intelligence Team's efficiency and Fabric's products at-large. - Technical Maintenance: Assist the Medical Intelligence Team with data analyses, platform implementations, and other improvements as needed. - Client Representation: Professionally represent Fabric in meetings with current and prospective clients, showcasing our expertise and commitment to innovative care. - Deliver on Deadline: Produce deliverables with specific and sometimes short deadlines, including document creation, workflow reviews, and other work relevant to the successful completion of these responsibilities. - Ad Hoc Responsibilities: Expect to be responsive to a variety of requests relevant to supporting Fabric's clinical logic products, the growth of the overall business, or the response to the unexpected. Qualifications - 5+ years as an Advanced Practice Provider (e.g., NP, PA). - Commitment to standard of care through unwavering dedication to current, accepted clinical practice guidelines and regulatory requirements. - Expert in efficient literature review (differential diagnosis, indicated diagnostics, first line treatments, patient education, and triage), supporting all decisions with evidence whenever possible. - You have applied AI agentic workflows in clinical practice or, at a minimum, are already using LLM and AI applications in your work and professional life. - Aptitude for learning new technological tools to support sound clinical decision making. - Proven ability to work well in multi-disciplinary teams outside of direct clinical care. - Detail-oriented mindset with capacity to work deep in the weeds with big picture vision in mind. - Positive, proactive, and clear communicator who collaborates well with MIT and cross-functional team members. - Excellent verbal and written communication, comfortable with both synchronous and asynchronous collaboration. - Native-speaker level of fluency in English (written and verbal). Benefits - The national pay range for this role is $140,000.00 – $160,000.00 per year. - Actual compensation will be determined by factors such as the candidate's geographic market, experience, skills, and qualifications. - Certain roles may also be eligible for additional compensation, including a comprehensive benefits package such as medical, dental, vision, unlimited PTO, and a 401(k) plan, stock options, and bonuses. This Might Not Be The Right Fit If... - You prefer direct patient care over the deep-work tasks described above; without bedside time, this role may feel isolating. - You are uncomfortable with the evolving space of AI, where guidelines and tools change weekly, or with the ambiguity of a startup environment. - You find cross-functional critique of your clinical judgement calls difficult; this role requires your clinical logic to be stress-tested by product managers and engineers. - You prefer big-picture thinking only; this role requires in-the-weeds work, manually reviewing hundreds of logic strings, auditing AI outputs, and ensuring every clinical branch is correct. - You prefer a strict clock-out mentality; while we value work-life balance, the pace of a growing health-tech company often requires ownership and responsiveness beyond a traditional shift-work mindset.