Study Start Up Operations Manager - Full Time - Wolf River - Registered Nurse (RN)/ Licensed Practical Nurse (LPN) Experience Required

<p><strong>Job Title: </strong>Manager, Study Start Up Operations</p> <p><strong>About Us</strong></p> <p>At West Cancer Center, we are committed to advancing innovative cancer research while delivering compassionate, patient-centered care. Our research teams play a critical role in expanding treatment opportunities and improving outcomes for patients through cutting-edge clinical trials and collaborative research initiatives.</p> <p><strong>Position Overview</strong></p> <p>The Manager, Study Start Up Operations is responsible for the strategic oversight, leadership, and operational management of all clinical trial study start-up activities across the research program. This role supervises the Study Start-Up Specialist and Research Specialist positions and serves as the primary operational lead for feasibility, site activation, sponsor communication, start-up timelines, and cross-functional coordination with regulatory, contracts/budgets, data services, and clinical research teams. The Manager ensures efficient activation of clinical trials while maintaining compliance with FDA regulations, GCP guidelines, sponsor requirements, and organizational policies. This position requires a licensed nurse with clinical research experience, leadership ability, and expertise in research processes.</p> <p><strong>Key Responsibilities</strong></p> <ul> <li>Directly supervises Study Start-Up Specialists and other assigned research start-up personnel</li> <li>Provides leadership, mentorship, training, and performance management for study start-up staff</li> <li>Develops departmental workflows, SOPs, and best practices related to study activation and feasibility processes</li> <li>Serves as escalation point for sponsors, CROs, investigators, and internal departments regarding study start-up issues or delays</li> <li>Collaborates with Research Leadership to establish departmental goals, activation metrics, and operational priorities</li> <li>Participates in strategic planning for research growth and study portfolio development</li> <li>Oversees all study start-up activities from initial feasibility through site activation and handoff to study conduct teams</li> <li>Reviews and assigns feasibility requests and ensures timely completion of sponsor-required questionnaires</li> <li>Oversees Confidential Disclosure Agreements (CDAs), protocol review workflows, and study routing processes</li> <li>Coordinates Research Steering Committee (RSC) and Disease Research Group (DRG) review processes</li> <li>Monitors study activation timelines and proactively addresses barriers to activation</li> <li>Oversees Site Qualification Visits (SQVs), Site Evaluation Visits (SEVs), and Site Initiation Visits (SIVs)</li>