University of Rochester
Sr. Clinical Trials Project Mgr.
University of Rochester, Rochester, New York, United States, 14618
Sr. Clinical Trials Project Manager
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: 265 Crittenden Blvd, Rochester, New York, United States of America, 14642 Opening: 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.
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: 265 Crittenden Blvd, Rochester, New York, United States of America, 14642 Opening: 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.