USA
3 days ago
Sr. Clinical Trials Project Mgr.
As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive. **Job Location (Full Address):** 265 Crittenden Blvd, Rochester, New York, United States of America, 14642 **Opening:** Worker Subtype: Regular Time Type: Full time Scheduled Weekly Hours: 40 Department: 400119 Surgery-Cancer Control Work Shift: UR - Day (United States of America) Range: UR URG 112 Compensation Range: $70,197.00 - $105,295.00 _The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations._ **Responsibilities:** GENERAL PURPOSE: The Sr. Clinical Trials Project Mgr. role supports the URCC NCORP Research Base, a large, national clinical trials network that spans over 700 sites and engages thousands of research personnel across the country. This position requires independence, proactivity, attention to detail, and top-level professionalism and discretion. As a strategic partner to the Executive Director, the Assistant Director ensures efficient operations, effective communication, and seamless management of priorities and projects. Responsibilities include overseeing day to day operational activities, leading cross-functional team initiatives and works closely with the Executive Director to ensure projects are aligned with strategic priorities. This job requires the individual to be on-site during regular business hours, Monday – Friday, approximately 8:30am – 5:00pm. This role may involve occasional evening or weekend work and infrequent travel to meet organizational needs and support research operations effectively. **ESSENTIAL FUNCTIONS** **Administrative and Operational Leadership and Support for Executive Director** + Serve as strategic partner to the Executive Director, providing high-level support in managing priorities, decision-making, and operational initiatives. + Oversee day to day operations of the URCC NCORP Research Base, ensuring smooth coordination across departments, research sites, and partner organizations. + Act as a liaison between the Executive Director and internal/external stakeholders, ensuring effective communication and follow-through on critical initiatives. + Lead cross-functional initiatives and special projects, driving execution on operational goals, strategic planning, and research objectives. + Supervise, coach, and mentor team managers and staff, fostering a collaborative, high-performance culture. + Monitor compliance with program guidelines, deadlines, and regulatory requirements, ensuring accountability across the Research Base. + Work collaboratively across functional teams to prepare reports for Executive Director on key updates, metrics, and milestones. + **Manage sensitive and complex situations** on behalf of the Executive Director, using sound judgment, high-degree of discretion, and professionalism. + **Provide comprehensive administrative support** **,** including calendar management, meeting coordination, agenda preparation, and tracking action items. + **Prepare high-quality reports, data, and visual materials** for presentations and communications for submissions to NCI, Department of Surgery, Wilmot Cancer Institute, etc. + **Coordinate travel arrangements, expense reporting, and financial processes, time off requests, timecards, and position management** through Workday and MyURHR. + **Prioritize and streamline incoming tasks and correspondence** , optimizing the Executive Director’s time and ensuring seamless workflow. **Research Grant and Publications Management** + Coordinate renewal grant applications, gathering and analyzing information from multiple sources, proofreading, and editing submissions. + Assist the Executive Director in preparing and submitting NIH grants (via ASSIST) and progress reports (via eRA Commons); maintain faculty CVs, Biosketches, and Other Support documents. + Support project budgeting, financial reporting, and expenditure tracking. + Assist with grant reviews, including downloading PDFs, reviewing scoring sheets, and uploading submissions. + Track abstracts, manuscripts, and authorship using spreadsheets; proactively manage submission timelines for upcoming scientific conferences (e.g., ACSM, ASCO, SBM). + Submits abstracts and papers to NCI for review and approval. + Solicit faculty contributions for publications and update tracking accordingly. + Support manuscript submissions to NIHMS, ensuring compliance with federal regulations. + Manage all publications in Endnote, maintain comprehensive library of all publications connected to the Research Base. Provides data and lists regarding publications as needed for grant proposals, presentations, and meetings. **NCORP Research Base Membership and Rostering Coordinator** + Manage and maintain up-to-date records for NCORP Research Base faculty and staff across multiple NCI systems, including the NCI Regulatory Support System (RSS) and NCORP-SYS, ensuring accuracy and compliance. + Oversee both internal and external rostering in NCI databases, coordinating with NCORP affiliate sites to ensure all personnel are properly credentialed and documented. + Collect, verify, and maintain NCI-required credentialing documentation from Research Base personnel and external collaborators, including CITI GCP, HSP certificates, COI forms, Biosketches, FDA Form 1572, and other regulatory documents. + Serve as the primary liaison with NCI for any rostering discrepancies or updates, ensuring that faculty and staff credentialing meets the latest NCI and federal guidelines. + Coordinate and track annual credentialing renewals and onboarding processes for new staff across multiple institutions, working closely with human resources, regulatory, and compliance teams to streamline efforts. + Proactively update the NCORP Research Base website with current roster information and collaborate with leadership to ensure publicly accessible data is accurate and comprehensive. + Support Research Base staff with technical guidance related to NCORP-SYS, NCI databases, and regulatory platforms, providing troubleshooting assistance as needed. **Website Content Management and Communications** + Collaborate with IT to oversee and maintain the URCC NCORP Research Base website, ensuring accurate and timely updates. + Plan, prepare, and post announcements, updates, and program highlights to keep the website current and aligned with research activities and achievements. + Coordinate with internal teams and stakeholders to gather content, ensuring messaging is clear, consistent, and relevant for external and internal audiences. + Monitor website analytics and user feedback, making recommendations to improve content engagement and functionality. + Ensure all website content complies with organizational policies, brand guidelines, and privacy requirements. **Research Base Event Planning** + Lead coordination of multiple Research Base events, including the URCC Annual Meeting, the URCC Cabinet Retreat, and the URCC Mid-Year Virtual Meeting, ensuring all arrangements are completed on schedule. + Assist the Executive Director and MPIs with agenda planning. + Work with IT to set up meeting web pages, polling, registrations, and reports to monitor registrations. + Coordinate the arrangement and preparation of event materials. + Prepare travel arrangements for invited guests. + Prepares event menus, ensure all dietary restrictions are accommodated. + Works directly with event personnel at venues to manage all meeting logistics, communicating relevant information to all stakeholders. **Mandated Federal Reporting (ClinicalTrials.gov, Cancer.gov, NIH Human Subjects)** + Serve as the primary point of contact for all NCORP protocols in Cancer.gov and ClinicalTrials.gov, coordinating with Study Chairs and staff to ensure compliance. + Register and update Research Base trials on ClinicalTrials.gov. + Ensure accuracy in post-submission Human Subjects reporting for the NCORP grant, resolving discrepancies between Cancer.gov and ClinicalTrials.gov. **Other projects and job duties as assigned** **QUALIFICATIONS** + Bachelor's degree and 5 years of relevant experience required. + Or equivalent combination of education and experience required. + Master's degree preferred. + At least 5 years of relevant experience (e.g., clinical research operations, research administration, or other directly relevant experience)required. + Prior management experience preferred. + Leadership and Operational Management: Proven ability to oversee daily operations, manage cross-functional teams, and execute strategic initiatives preferred. + Project Management Skills: Experience using tools like WRIKE, Doodle Poll, and SurveyMonkey to plan, coordinate, and track progress on projects and events preferred. + Communication and Interpersonal Skills: Exceptional verbal and written communication skills with a professional tone in all correspondence preferred. + Administrative Expertise: Strong background in scheduling, travel coordination, expense reimbursement, and calendar management. + Technology Proficiency: Skilled in Microsoft Word, Excel, PowerPoint, Zoom, and other virtual collaboration platforms preferred. + Event Planning and Logistics: Experience organizing meetings, retreats, and events, including arranging travel, managing food orders, and coordinating housing for international speakers preferred. + Attention to Detail and Discretion: Ability to manage sensitive information and complex situations with sound judgment and confidentiality preferred. + HR and Compliance Coordination: Familiarity with HR forms and regulatory requirements for credentialing and reporting (e.g., ClinicalTrials.gov) preferred. + Research Operations Knowledge: Understanding of the structure and demands of clinical trials and multi-site research networks. + Proactive and Independent Problem-Solving: Ability to anticipate needs, follow up on tasks without prompting, and manage competing priorities effectively preferred. + Flexibility and Time Management: Ability to adapt to changing priorities, work occasional evenings or weekends, and travel as needed to support research operations preferred. + CCRP - Certified Clinical Research Professional upon hire preferred. + Certified Project Management Professional (PMP)-PMI upon hire preferred. **EOE Minorities / Females / Protected Veterans / Disabled:** The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion to advance the University’s mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other status protected by law. This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations. Notice: If you are a **Current** **Employee,** please **log into myURHR** to search for and apply to jobs using the Jobs Hub. Your application, if submitted using this portal, cannot be moved forward. **Learn. Discover. Heal. Create.** Located in western New York, Rochester is our namesake and our home. One of the world’s leading research universities, Rochester has a long tradition of breaking boundaries—always pushing and questioning, learning and unlearning. We transform ideas into enterprises that create value and make the world ever better. If you’re looking for a career in higher education or health care, the University of Rochester may offer the perfect opportunity for your background and goals At the University of Rochester, we commit to diversity, equity, and inclusion and united by a strong commitment to be ever better—Meliora. It is an ideal that informs our shared mission to ensure all members of our community feel safe, respected, included, and valued.
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