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 an experienced and adaptable Clinical Research Operations Specialist to oversee the planning, implementation, and management of oncology clinical trials across multiple trial sites within the N-Power Network. This role serves as a key operational bridge between internal teams, trial site personnel, and external pharma or CRO partners, ensuring streamlined communication, executional excellence, and a superior experience for all stakeholders. This role will proactively identify potential barriers to successful implementation of the trial work plan and develop strategic solutions to mitigate those challenges, while driving efficient resource allocation, regulatory and protocol adherence, and timely delivery of study milestones. This customer-facing role requires expertise in clinical trial management, site operations, stakeholder engagement, and process optimization. This is a highly visible and impactful position within a dynamic, rapidly evolving organization—ideal for someone who excels at creative problem solving, thrives in ambiguity, and brings both rigor and flexibility to clinical trial operations. This position is remote within the United States. Objectives and Responsibilities - Oversee the end-to-end implementation and execution of assigned oncology studies across multiple Network sites, ensuring compliance with study protocols, timelines, and regulatory requirements. - Act as a strategic liaison between pharma sponsors, contract research organizations (CROs), clinical sites, and internal teams to ensure alignment and execution of study objectives. - Proactively identify operational risks and implement creative, timely solutions (SOPs, tools, and best practices) to optimize clinical trial workflow, patient recruitment, and data quality. - Collaborate with regulatory, data, quality, and site teams to ensure compliance with applicable regulations and internal SOPs. - Monitor trial progress, identify bottlenecks, and proactively address identified operational challenges. - Review and provide input on essential study documents (e.g., protocols, informed consents, site training materials). - Oversee trial-specific training for internal stakeholders and site teams. - Responsible for operational input and oversight in designing, planning, initiating and completing clinical trials across assigned disease teams. - Lead clinical study and cross functional team to make key decisions related to strategy and issue resolution. - Participate in initiatives to establish best practices for optimizing patient enrollment in clinical trials. - Collaborate with stakeholders to develop and implement trial specific training programs. - Innovate and implement novel patient enrollment strategies to maximize clinical trial participation. - Identify and integrate new tools, workflows, and methodologies to improve protocol implementation and patient enrollment processes. - Perform additional duties and responsibilities as required. Compliance & Quality Assurance - Ensure all trial activities comply with Good Clinical Practice (GCP), Institutional Review Board (IRB) guidelines, FDA regulations, and health system policies. - Work closely with other N-Power teams to support submissions, audits, and inspections. Performance & Reporting - Track key performance indicators (KPIs) related to trial enrollment, retention, protocol adherence, and data integrity. - Provide regular updates and reports to senior leadership, sponsors, and other key stakeholders. - Utilize data-driven insights to recommend operational improvements and enhance trial efficiency. Qualifications - 5+ years in clinical trial operations, with experience in a health system setting preferred. - Bachelor’s degree in life sciences, healthcare administration, or a related field required; Master’s degree (MPH, MBA, MS) or clinical background (RN, PharmD) preferred. - 2+ years in oncology clinical trial experience preferred. - Strong understanding of clinical research protocols, regulatory requirements, and site management best practices. - Exceptional project management and organizational skills. - Strong interpersonal and relationship-building abilities. - Ability to manage multiple priorities in a fast-paced environment. - Proven ability to navigate highly matrixed environments, managing multiple stakeholders and priorities. - Strong track record of successfully executing projects under tight timelines. - Exceptional interpersonal and communication skills, with the ability to engage and influence senior stakeholders, clinical teams, and technical experts. - Demonstrated ability to inspire teams, foster collaboration, and drive meaningful impact in clinical research. - Prior experience in management or leading cross functional teams is desirable. - Generous, Curious and Humble. Travel Requirements - Ability to travel, up to 10%, may be required. Pay Information - The expected salary range for this position is $108,000 and $143,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. - N-Power Medicine (NPM) offers equity at hire as well as a discretionary annual bonus which may be available based on Company performance. - This position is eligible for company benefits.

• Support site start-up activities, including creation of study templates, CRFs, study manuals, site shipments, investigator binders and investigational device accountability. • Support data entry, query tracking, and remote and on-site monitoring needs in collaboration with CRO and internal team members. • Support or lead IRB submissions. • Maintain essential documents in the Trial Master File (TMF) per regulatory and company standards. • Coordinate clinical trial logistics such as meeting scheduling, site communications, and shipping of study materials. • Collaborate with CRO, central reading centers and other vendors as needed. • Draft and distribute study-related communications, agendas, and minutes. • Ensure adherence to GCP, ISO 14155, and regulatory guidelines with supervision. • Assist in the preparation of clinical study reports, presentations, and regulatory submissions. • Contribute to the development of SOPs, templates, and internal workflows.

• Independently coordinate assigned study activities in compliance with protocols, SOPs, GCP, and regulatory requirements. • Screen and evaluate potential research participants for eligibility, documenting inclusion/exclusion criteria and escalating complex questions as needed. • Manage scheduling and execution of virtual and home-based study visits, assessments, and follow-up activities. • Collect, review, and enter study data accurately and in a timely manner using EDC systems and study tools. • Maintain complete, accurate, and audit-ready study documentation, including regulatory binders, participant records, and tracking logs. • Conduct or support informed consent discussions, ensuring proper documentation, version control, and regulatory compliance. • Serve as a primary point of contact for research participants and caregivers, addressing routine questions and coordinating logistics. • Prepare for and support sponsor, IRB, and regulatory monitoring visits, including responding to document requests and resolving findings. • Track and report study metrics such as enrollment, retention, deviations, and visit completion. • Identify operational risks or inefficiencies and proactively communicate improvement opportunities to research leadership. • Collaborate closely with investigators, care coordinators, and cross-functional teams to ensure a high-quality research experience. • Support onboarding and informal mentoring of junior research staff, as appropriate.

• Leads statistical support for post approval value evidence generation and reimbursement submissions. • Conducts post hoc analysis to support publications and presentations. • Reviews and authors abstract, manuscript, regulatory documents. • Collaborates with cross-functional team to support observational studies. • Develops statistical sections of study protocols and statistical analysis plans. • Collaborates with Data Management and Medical Research on design of eCRFs. • Provides statistical guidance on conduct of ongoing studies. • Accountable for the collaboration with Statistical Programming to implement statistical analysis of all clinical trial, registry, observational and non-interventional data supporting Medical Affairs needs. • Contributes to observational study reports and regulatory documents, e.g., DSURs, briefing documents, etc. • Contributes to scientific articles, summarizing data collected in sponsor studies. • Participates in other activities and meetings to support Biostatistics and the Medical Affairs team as needed.