Role Description The primary responsibility of the Clinical Research Associate I (CRA I) is support of the research team in the conduct of department research projects. - Perform study startup, implementation, and closeout activities - Assist research team with coordination and entry of research data - Assist with regulatory submissions to the Institutional Review Board, and maintain compliance with all federal and local agencies in accordance with Good Clinical Practice guidelines - Interact with patients and families for securing informed consent, scheduling research visits, and collection of data - Maintain documentation for regulatory binder, adverse event reporting, and communications between sponsors and sites - Other special skills specific to assigned research area may include phlebotomy, sample collection, processing or shipping, ECGs, chart abstraction or other duties as assigned - Manage personal career development and administrative tasks Qualifications - Baccalaureate degree or at least 4 years relevant clinical research, professional experience - High attention to detail with strong written and oral communication skills - Strong computer skills beyond basic familiarity with the most common hardware and software systems - Ability to assist staff working on multiple projects - Experience working with pediatric populations (preferred) Requirements - Promotion to next higher level, typically CRA II, is determined by the Clinical Research Program Manager through performance reviews that take into account both experience carrying out the department's job-related duties/tasks, as well as a demonstrated commitment to professionalism in carrying out those tasks in line with Children's values and organizational policies and procedures. Benefits - Medical, dental, vision, retirement, and other fringe benefits - Positions that require night, weekend or on-call work may be eligible for shift differentials or premium pay

Role Description The PRN Clinical Review Specialist provides clinical review support on an as needed basis to assist with an increase in inventory and client demand. This role is responsible for reviewing medical records for medical necessity, level of care, authorization compliance, and payer guideline alignment across inpatient and outpatient services. The position supports timely appeal submissions and inventory management while maintaining quality and compliance standards. Essential Duties and Responsibilities - Perform clinical reviews for medical necessity, level of care, and authorization-related denial. - Review inpatient and outpatient medical records to support appeal submissions. - Apply payer-specific guidelines (CMS, Medicaid, commercial) and internal policies. - Identify documentation gaps and support clear, defensible clinical narratives. - Meet assigned turnaround times while maintaining quality standards. - Document review findings accurately in designated systems. - Collaborate with clinical leadership as needed for escalations or complex cases. Qualifications - Active, unrestricted RN license (compact preferred). - Minimum 4–5 years of clinical experience. - 4+ years of Utilization Review, Appeals, or Clinical Review experience. - Strong knowledge of medical necessity criteria and payer guidelines. - Experience reviewing inpatient and/or outpatient hospital claims. - Proficiency with EMRs and review platforms (Epic preferred). - Strong written clinical documentation and time management skills. Preferred Qualifications - Experience with payer appeals (medical necessity, no-auth, readmissions). - Familiarity with InterQual, MCG, or payer-specific criteria. - Prior remote clinical review experience. - Multi-client or vendor-side experience. - Knowledge of Medicare, Medicaid, and commercial payer processes. Work Expectations - Remote, independent work with defined productivity expectations. Performance Expectations - Timely completion of assigned reviews. - Accurate application of clinical criteria and payer policy. - Clear, compliant documentation. - Ability to adapt to changing inventory and priorities. Physical Demands Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions as described. Regular eye-hand coordination and manual dexterity is required to operate office equipment. The ability to perform work at a computer terminal for 6-8 hours a day and function in an environment with constant interruptions is required. At times, Team Members are subject to sitting for prolonged periods. Infrequently, Team Members must be able to lift and move material weighing up to 20 lbs. Team Members may experience elevated levels of stress during periods of increased activity and with work entailing multiple deadlines.

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.