Vitalief

Title: Director, Clinical Research Operations Transformation Location: Orange, NJ Full Time Hybrid Job Description: ABOUT VITALIEF Vitalief is a trusted partner to Sponsors, CROs, and Sites across the research and clinical trials landscape. By blending deep subject matter expertise with strong business acumen, we deliver Consulting and Functional Service Provider (FSP) solutions that empower organizations to do more with less, streamlining operations, reducing costs, and accelerating breakthroughs that ultimately benefit patients.​ POSITION OVERVIEW We are seeking a highly experienced, strategic yet hands-on Clinical Research Operations Leader to join our delivery team as a full-time, fully benefited employee. In this role, you will partner with a multi-location community hospital system to transform its research enterprise into a scalable, high-performing, world-class clinical research operation. As the primary subject matter expert (SME), this leader will collaborate closely with the Vitalief delivery team to design and implement enterprise-level operational initiatives, with a strong emphasis on Non-Oncology programs and enhancing cross-system communication and coordination. A central focus of the role will be leading the operational build-out and execution of a Cardiovascular clinical trials pilot, including infrastructure development, staffing strategy, workflow optimization, and technology deployment. WHY VITALIEF? - Professional Growth: Join a team of experienced practitioners who bring both business acumen and domain expertise. - Impactful Work: Contribute to scientific advancements that directly improve patient lives. - People-First Culture: Thrive in an environment that fosters growth, innovation, and collaboration. - Comprehensive Benefits: Enjoy 20 PTO days, 9 paid holidays, company-paid life insurance, short- and long-term disability, a 401(k) retirement plan, and robust healthcare options. - Flexible Work Location: Hybrid role with 2–3 days per week onsite in the Orange, NJ area. - Competitive Compensation: Base salary, performance bonus, and equity incentives. KEY RESPONSIBILITIES - What Success Looks Like: - Successful design, launch and operational stabilization of a scalable Cardiovascular research pilot across multiple hospital campuses and ambulatory sites. - Aligned research strategy with institutional priorities through close partnership with executive, clinical, and administrative leadership. - Established standardized workflows, SOPs and enterprise-wide performance metrics for research operations. - Strengthened investigator engagement and increased research participation across service lines. - Established scalable infrastructure and service line activation frameworks, in collaboration with investigators and sponsors, to reduce study activation timelines, enhance start-up predictability, and support sustainable research growth. - Successfully managed cross-functional initiatives within matrixed reporting environments and complex academic-clinical governance structures. - Transition from opportunistic research conduct to a deliberate, strategic, and scalable clinical research enterprise. QUALIFICATIONS - Bachelor’s degree required; Master’s degree in Clinical Research Administration, Public Health, Nursing, or related field strongly preferred. - Minimum of 7 to 10 years of progressive clinical research operations experience, including 3 to 5 years in leadership or management roles. - Experience building and launching a clinical research multi-location operation from scratch, enabling timely initiation of multiple studies across diverse therapeutic areas. - Demonstrated experience leading and supporting complex multi-site clinical research settings, including academic medical centers, affiliated and non-academic health systems, and disparate research locations. - Demonstrated experience managing complex drug, device, adaptive, or multi-arm trials. - Cardiovascular clinical research experience strongly preferred. - Expertise in study start-up optimization, IRB processes, and regulatory compliance. - Experience with CTMS platforms (e.g., OnCore) and Epic research integration. - Strong knowledge of research billing compliance and Medicare clinical trial requirements. - Proven ability to develop SOPs, quality systems, and performance dashboards. - Experience strong relationships with sponsors and CRO partners to enhance site reputation and repeat business opportunities. - Strong executive presence with the ability to influence across matrixed environments. - Demonstrated success leading operational transformation or research program development initiatives. PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs. IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis.

Title: Associate Director of Oncology Clinical Trials Nursing Location: New Brunswick, NJ Full Time Senior Manager/Supervisor Job Description: ABOUT VITALIEF Vitalief partners with Sponsors, CROs, and research sites across the clinical trials ecosystem, delivering consulting and workforce solutions that improve efficiency, reduce costs, and accelerate patient-impacting innovation. By embedding highly skilled professionals directly into client teams—while maintaining them as Vitalief employees—we provide flexible, seamless access to expertise without increasing internal headcount. POSITION OVERVIEW We are seeking an experienced Oncology Nurse Leader with clinical research experience to join Vitalief as a full-time, fully benefited employee. In this role, you will support a premier clinical research site in New Brunswick, NJ, in building a high-performing centralized clinical research nursing structure. This is a high-impact leadership role responsible for strengthening operations, elevating clinical quality, and shaping the future of oncology research nursing. This resource will manage and lead 20 research nurses and help advance innovative care models, including telehealth and remote consenting initiatives. BENEFITS OF WORKING AT VITALIEF - Professional Growth: Opportunity to lead a team of ~20 research nurses; Potential expansion into multi-site or statewide leadership roles. - Impactful Work: Contribute to scientific advancements that directly improve patient lives. - People-First Culture: Thrive in an environment that fosters growth, innovation, and collaboration. - Comprehensive Benefits: Enjoy 20 PTO days, 9 paid holidays, company-paid life insurance, short- and long-term disability, a 401(k) retirement plan, and robust healthcare options. - Work Location: Four days on-site in New Brunswick, NJ and one day remote weekly. - Salary Range: $150,000 to $175,000 (depending on experience level). RESPONSIBILITIES - Reporting to the Executive Director of Clinical Research, provide leadership and oversight of Oncology Clinical Research Nurses (~20 direct reports). - Ensure high standards of clinical quality, protocol adherence, and patient safety. - Assess and maintain clinical competency across the nursing team. - Mentor, coach, and develop nursing staff at varying levels of experience. - Address clinical and operational issues, including documentation and patient assessments. - Lead and support strategic initiatives, including Remote consenting workflows; Telehealth integration in clinical research; Health literacy and patient engagement programs. - Help establish a more centralized and structured research nursing model. - Partner with leadership to advance the role and visibility of research nursing within the organization. QUALIFICATIONS - Minimum of 8 years of combined experience in healthcare and clinical research as a Registered Nurse, including leadership or nurse management experience. - Active RN license. - BSN degree required. Master’s or Doctoral degree is strongly preferred. - Current American Heart Association Basic Life Support (BLS) certification is required. - 3 years of experience in a nursing leadership or supervisory role within an inpatient or outpatient care setting. - 2 or more years of oncology nursing experience. - Minimum of 1 year of clinical research environments or clinical trials. - Strong leadership presence with the ability to mentor, guide, and inspire clinical teams. - Strategic, innovative mindset with a passion for advancing oncology research, program development, and improving patient care delivery. - Excellent communication and organizational skills, with strong attention to detail and the ability to manage multiple priorities and stakeholders effectively. - Proficiency and working knowledge of database and reporting tools such as Microsoft Word, Excel, Access, Teams, Planner, and PowerPoint. Working knowledge of Advarra OnCore is preferred. PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs.

• Serve as the lead Clinical Research SME for the engagement, guiding all aspects of the operational assessment and change management strategy. • Conduct in-depth interviews with clinical research staff and stakeholders across the clinical trial lifecycle to identify operational gaps, bottlenecks, communication challenges, and improvement opportunities across Oncology and Non-Oncology programs. • Partner with executive and operational stakeholders to assess organizational readiness for change and recommend sustainable transformation strategies. • Collaborate with the Vitalief team to design effective interview templates, assessment methodologies, and change management frameworks. • Evaluate current-state workflows, governance structures, staffing models, and technology utilization to identify opportunities for operational alignment and standardization. • Compare Oncology and Non-Oncology operations to identify transferable best practices and opportunities for cross-functional integration. • Develop prioritized, actionable recommendations that address immediate operational challenges while supporting long-term scalability and organizational adoption. • Create and present a clear transformation roadmap focused on operational excellence, stakeholder engagement, process optimization, and effective cross-system coordination. • Provide regular project status updates to executive stakeholders, ensuring alignment, transparency, and on-time delivery of engagement milestones. • Deliver executive-level presentations summarizing findings, recommendations, change impacts, and measurable next steps.

• Develop, build, and finalize clinical trial budgets for industry-sponsored studies (oncology and non-oncology) • Perform detailed Medicare Coverage Analyses (MCA) to accurately distinguish routine care vs. research-related costs • Configure and maintain study calendars, budgets, and billing grids within OnCore • Support clinical trial start-up by ensuring accurate budget setup, billing designation, and downstream readiness • Lead or support budget negotiations with sponsors and CROs • Partner closely with investigators, study coordinators, finance, and revenue cycle teams to validate assumptions • Conduct ongoing budget tracking, reconciliation, and variance analysis • Identify and address billing compliance risks • Assist in audit readiness activities • Standardize and improve budgeting and coverage analysis workflows • Serve as a subject matter expert for clinical trial budgeting, billing compliance, and OnCore functionality • Provide hands-on support across multiple client engagements

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description We are seeking a full-time, fully benefited Vitalief employee to serve as a Clinical Trials Coverage Analyst in a fully remote capacity, supporting a leading academic clinical research center in Chicago. The ideal candidate brings strong expertise in Medicare billing guidelines, clinical trial operations, experience working on Oncology protocols, and OnCore calendar builds, and will ensure compliance while supporting clinical trial billing operations and advising key stakeholders. Key Responsibilities - Conduct Medicare Coverage Analyses (MCA) for a mixture of oncology and non-oncology clinical trial protocols identifying which procedures and services are billable to Medicare versus those considered research related. - Review clinical trial protocols, schedules of events, and informed consent forms to ensure billing compliance with CMS regulations. - Develop, maintain, and validate OnCore calendar builds for clinical trial visits, procedures, and study milestones. - Collaborate with cross-functional teams including Clinical Operations, Finance, Regulatory, and Study Teams to provide guidance and clarification on coverage decisions. - Prepare and maintain coverage analysis documentation, summary tables, and billing justification reports for both internal and external stakeholders. - Serve as a subject matter expert for Medicare coverage rules, assisting study teams in identifying potential billing risks and providing actionable recommendations. - Support internal and external audits, ensuring all coverage decisions are well-documented and compliant with federal and sponsor requirements. - Keep current with CMS updates and industry best practices, applying knowledge to optimize coverage analyses and study operations. Qualifications - Bachelor’s degree in Healthcare Administration, Medical Coding, Auditing, Finance, Accounting, Nursing, or a related field. - Minimum 3 years of Medicare Coverage Analysis experience in clinical research or healthcare billing. - Must have experience working on oncology clinical trial protocols. - Hands-on experience developing, maintaining, and validating OnCore calendar builds for clinical trial visits, procedures, and study milestones is preferred – but not required as training will be provided. - Strong understanding of CMS guidelines, Medicare billing compliance, and clinical trial operations. - Demonstrated ability to work independently and manage multiple protocols and deadlines simultaneously. - Exceptional attention to detail, analytical skills, and problem-solving abilities. - Strong written and verbal communication skills, with the ability to explain complex billing concepts to non-technical stakeholders. - Comfortable working in a fully remote environment, collaborating effectively with distributed teams across multiple locations. - Proficiency in document and data management tools, including Microsoft Word, Excel, PowerPoint, Adobe, Teams, and SharePoint. Physical Demands - Standing, sitting, walking, visual perception, talking and hearing. - Lifting up to 20lbs. Important Note Vitalief partners with clients such as major medical centers and academic institutions that often require all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description We are seeking a full-time, fully benefited Clinical Trials Contracts Specialist to join Vitalief in a fully remote position supporting our client, a leading academic clinical research center in New Jersey. The ideal candidate will bring extensive experience in clinical research contract review and negotiation, along with a strong understanding of regulatory, legal, and operational requirements. In this role, you will develop and sustain strategic partnerships with industry sponsors while ensuring the timely and effective review, negotiation, and management of clinical trial agreements and related research contracts. Qualifications - Bachelor’s degree in Paralegal Studies, Law, or related field required; JD preferred. - Minimum of 3 years of clinical trial agreement review and negotiation experience, including at least 2 years within an academic medical research environment. - Demonstrated experience negotiating both industry-sponsored and non-industry clinical trials. - Strong knowledge of clinical research regulations and institutional policy frameworks. - Excellent written and verbal communication skills, with the ability to convey complex information clearly and effectively. - Proven ability to manage multiple priorities independently, exercise sound judgment, and collaborate effectively across departments. - Detail-oriented, proactive, and committed to delivering exceptional customer service. Requirements - Independently review, interpret, negotiate, and process clinical trial agreements, nondisclosure agreements, and related contracts from legal, business, and technical perspectives, ensuring alignment with institutional policies and sponsor requirements. - Develop and execute negotiation strategies that align with institutional policies, regulatory requirements, and sponsor expectations. - Provide guidance on contract terms, risk assessment, and industry best practices. - Collaborate with General Counsel, Risk Management, Research Commercialization, finance, and other internal stakeholders to resolve legal and business matters. - Maintain proactive communication with sponsors and internal teams, providing timely updates and resolving contractual issues. - Ensure contract packages are complete, accurate, and properly maintained, including electronic files and negotiation histories. - Support timely study start-up by coordinating executed agreements and distributing required documentation upon SRB approval. - Serve as a subject matter expert in clinical research contract management and maintain compliance with institutional, federal, and state regulations. - Participate in performance improvement initiatives and ongoing training to remain current on regulatory and institutional requirements. Benefits - Work remotely while supporting high-impact clinical trials. - Standard work hours: 8:00am to 4:30pm EST zone. - Contribute to advancing scientific discoveries that improve patient lives. - PEOPLE FIRST culture with opportunities for growth and innovation. - Competitive benefits include 20 PTO days + 9 paid holidays; Company-paid life insurance and short/long-term disability; 401(k) retirement program; Comprehensive healthcare plans. - Market-competitive salary: commensurate with experience. Physical Demands - Standing, sitting, walking, visual perception, talking and hearing. - Lifting up to 20lbs. Important Note Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis.

We are seeking a full-time, fully benefited Vitalief employee to serve as a Medicare Coverage Analyst in a fully remote capacity, supporting a leading academic clinical research center in Chicago. The ideal candidate brings strong expertise in Medicare billing guidelines, clinical trial operations, and OnCore calendar builds, and will ensure compliance while supporting clinical trial billing operations and advising key stakeholders. Conduct Medicare Coverage Analyses (MCA) for clinical trial protocols, identifying which procedures and services are billable to Medicare versus those considered research related. Review clinical trial protocols, schedules of events, and informed consent forms to ensure billing compliance with CMS regulations. Develop, maintain, and validate OnCore calendar builds for clinical trial visits, procedures, and study milestones. Collaborate with cross-functional teams including Clinical Operations, Finance, Regulatory, and Study Teams to provide guidance and clarification on coverage decisions. Prepare and maintain coverage analysis documentation, summary tables, and billing justification reports for both internal and external stakeholders. Serve as a subject matter expert for Medicare coverage rules, assisting study teams in identifying potential billing risks and providing actionable recommendations. Support internal and external audits, ensuring all coverage decisions are well-documented and compliant with federal and sponsor requirements. Keep current with CMS updates and industry best practices, applying knowledge to optimize coverage analyses and study operations.

• Collaborate with clinicians, researchers, and cross-functional teams to design and implement data science solutions that advance clinical research goals. • Conduct real-world evidence studies leveraging EHR data and unstructured clinical text mining. • Analyze large and complex clinical datasets using advanced statistical methods. • Develop predictive models and apply machine learning (ML) techniques to identify patterns, biomarkers, or risk factors in patient data. • Create visualizations and dashboards that effectively communicate complex findings to both technical and non-technical stakeholders. • Conduct data cleaning, preprocessing, and transformation to prepare datasets for analysis. • Apply Natural Language Processing (NLP) to extract insights from unstructured data such as clinical notes and patient narratives. • Work with large-scale healthcare data environments using big data frameworks and cloud computing platforms. • Ensure data integrity, security, and compliance with HIPAA and other relevant regulations. • Stay current with emerging technologies and methodologies in the data science and healthcare domains.