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 111 Compensation Range: $63,815.00 - $95,723.00 _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 Clinical Trials Project Manager II is responsible for leading the planning, implementation, and monitoring for multiple, large, national, multi-site clinical research protocols in a network of over 600 community sites. Under oversight of the Sr. Clinical Research Project Manager, the CRPM will manage multiple studies’ day-to-day operations, carry out project management for clinical trials run through the URCC NCORP network from protocol development and initiation to study close-out according to regulatory/NCI guidelines, and ensure each study’s integrity. S/he will monitor and maximize adherence to research standards, regulatory guidelines, and approved operational procedures; work closely with study team members and other staff/faculty/study sites from all cross functional teams to ensure study participant safety and adherence to study protocol; manage study-related tasks; and facilitate across-the-board flow of information, orchestrating study activities and personnel. The CRPM will facilitate excellent customer service and guidance to clinical and study teams in the clinical trials environment. **ESSENTIAL FUNCTIONS** **Manage all aspects of assigned high volume, multisite clinical research projects including:** + Serve as the primary contact for protocol and data-related questions and issues from off-site locations. The URCC NCORP Research Base has 30+ members, each of which are comprised of many community sites, over 600 in total. + Ensure off-site investigators and their clinical research staff understand and adhere to all aspects of assigned protocols, procedures, interventions, and standards for documentation and communication + Train sites research staff on details of study activities, including inclusion and exclusion criteria, informed consent procedures, process for source documentation and case report form (CRF) completion, and adverse event reporting + Assist with monitoring the studies regularly for conformity with standard operating procedures, and verify data to ensure compliance with requirements of the protocol, Research Base, IRB, University and federal regulations + Track study-specific metrics (i.e., overdue data, open queries, etc.) and ensures issues are addressed promptly. + Learn and maintain working knowledge of software and/or specialized equipment, procedures and interventions used in each project + Develop and maintain workflow, records of research activities, and prepare periodic and ad hoc reports, as required by investigators and/or regulatory bodies. + Ensure protocol timelines are met-patient, study, data + Ensure proper reporting of adverse events to PI and Research Base Administration + Attend and present updates at weekly study management team meetings **Maintains oversight of high-volume study data for the assigned projects:** + Work with Data Management, IT and Biostatistical teams to establish appropriate data handling procedures, methods for collection, databases, coding keys, storage, and tracking of data for assigned projects. + Oversee receipt and verification of incoming data received from our community sites in multiple formats, i.e., REDCap, scannable paper forms, activity trackers, electronic cognitive assessments, heart rate monitors and audio recordings of treatment sessions. + Works collaboratively with Data Management to provide the study team and URCC leadership with accurate reports on status of data for assigned projects including – data processing status, outstanding data, and trends. + Analyze and suggest improvements in flow of information, error detection/correction, etc., + Maintain database integrity; review and evaluate patient data for statistical analysis, work with biostatistics team to resolve discrepancies or problems + Develop and produce reports of study data for project staff and stakeholders, including study deviations and adverse events. Contributes meaningful information to enhance publications or grant applications **Study Development:** + Manages the assigned project during the critical development and launch period, and is responsible for working with the Principal Investigator(s) and all cross functional teams to assess the scope of work, deliverables, timelines, milestones and relevant metrics to track progress and ensure all deadlines are met successfully. + Work with Principal Investigator(s) and study team in the development of protocols, data collection forms, training materials, and determining what study supplies will be needed and ordered on schedule as outlined at project kick off, evaluating any changes in plans and needs for adaptation. + Review and edit the protocol and data forms with a high degree of attention to detail for new projects under development. Works across all teams to ensure all requirements are met, questions resolved and URCC policies and procedures are met. **Study Agents, Supplies and Equipment:** + Ensures Investigational Drug Service distributes study agent to off-site locations as applicable. + Works with the URCC Biobank to design and build biospecimen collection kits and laboratory manuals and training materials, and to obtain reports as needed of status of specimen receipt and quality from community sites. + Receive requests for and ship study-specific drug, supplies and equipment (e.g., devices such as activity trackers, heart rate monitors TENS units, recording equipment, training materials, manuals) for active clinical trials + Maintain shipping logs and database, track expiring supplies and communicate with sites, replace with in-date supplies + Produce laboratory reports **Miscellaneous:** + Serve as site auditor, primarily reviewing selected patient cases to ensure compliance with protocol; assist Lead Auditor in compiling information gathered during the audit for the final report to the NCI + Provide support and backup for projects assigned to other URCC CRPMs as needed. + Maintains current working knowledge of clinical research best practices, updates to federal regulatory, Good Clinical Practice, current industry standards for clinical research and project management professionals by regularly attending training sessions, meetings and conferences. + Needs to be available approximately 1-3x/year to travel overnight for meetings and/or conferences. **Other duties as assigned** **QUALIFICATIONS** + Bachelor's degree in health or social science field and 2 years of relevant experience required + Or equivalent combination of education and experience required + 2-3 years of clinical trials experience required + Or equivalent combination of education and experience required + Knowledge of Good Clinical Practice, protocol planning, implementation, coordination, evaluation, and reporting of clinical trials required. + Strong communication skills, interpersonal skills, attention to detail, and organization skills required + Excellent communication and organizational skills; attention to detail and problem-solving skills are essential required. + Ability to handle several projects simultaneously, prioritize and shift priorities quickly required. + Knowledge of computer databases, word processing, spreadsheets and graphics packages are important required. + Clinical trials project management experience 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.