Study Start Up Operations Manager - Full Time - Wolf River

<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> <li>Ensures smooth transition of activated studies to Clinical team</li> <li>Maintains oversight of sponsor communications and manages sponsor expectations throughout the start-up process</li> <li>Oversees maintenance of staff training records, GCP documentation, and protocol-specific training documentation</li> <li>Collaborates with contracts/budget and regulatory teams to support timely study activation</li> <li>Monitors study start-up metrics including activation timelines, pending studies, feasibility outcomes, and sponsor responsiveness</li> <li>Works collaboratively with investigators, research nursing, regulatory, data management, pharmacy, laboratory, finance, and sponsor representatives</li> <li>Interfaces with pharmaceutical companies, CROs, and external research partners</li> <li>Participates in department meetings, sponsor meetings, and organizational initiatives</li> <li>Maintains professionalism, confidentiality, and ethical standards in all interactions</li> <li>Supports special projects and strategic initiatives as assigned by Research Leadership</li> <li>Performs all other duties as assigned</li> </ul> <p><strong>Qualifications</strong></p> <p><strong>Education &amp; Experience</strong></p> <p><strong>Required:</strong></p> <ul> <li>Minimum of two (2) years of clinical research experience required</li> <li>Strong knowledge of FDA regulations, ICH-GCP guidelines, and clinical trial start-up processes</li> <li>Experience with feasibility assessments, sponsor communications, and study activation workflows</li> <li>Excellent organizational, analytical, and problem-solving skills</li> <li>Ability to manage multiple projects and priorities in a fast-paced environment</li> <li>Strong verbal and written communication skills</li> <li>Proficient in Microsoft Office applications including Excel, Word, Outlook, and Adobe Acrobat</li> </ul> <p><strong>Preferred:</strong></p> <ul> <li>Experience with CTMS preferred</li> </ul> <p><strong>Credential/Licensure</strong></p> <p><strong>Required:</strong></p> <ul> <li>Current RN/LPN license required</li> </ul> <p><strong>Work Environment &amp; Physical Demands</strong></p> <ul> <li>Typical clinical and office environment with moderate noise level</li> <li>Ability to sit, stand, walk, reach, bend, and use hands/wrists for extended periods of time</li> <li>Ability to effectively communicate verbally and in writing</li> <li>Ability to lift up to 25 pounds</li> <li>Occasional travel for investigator meetings, sponsor visits, or conferences may be required</li> </ul> <p><strong>Why West Cancer Center is a Great Place to Work</strong></p> <ul> <li>Meaningful Impact: Play a direct role in supporting patients through one of the most challenging times of their lives.</li> <li>Collaborative Culture: Work alongside a multidisciplinary team of dedicated professionals committed to improving cancer care.</li> <li>Professional Development: Benefit from ongoing training, educational resources, and growth opportunities.</li> <li>Mission-Driven Environment: Be part of an organization guided by compassion, integrity, and innovation.</li> </ul> <p><strong>No nights, weekends, or holidays. Comprehensive benefits package.</strong></p> <p><strong>Join Us</strong></p> <p>If you are a detail-oriented clinical research professional with leadership experience and a passion for advancing oncology research operations, we encourage you to apply for the Manager, Study Start Up Operations position at West Cancer Center.</p>