GENERAL PURPOSE: The Clinical Project Manager II assists with coordinating all aspects of multi-center clinical research trials in a Contract Research Organization (CRO) environment. This individual serves as a liaison with clinical trial sites to address protocol questions and relay study related information. Assists with development and execution of trial activities, including maintenance of study timelines and development of study related documents. **JOB DUTIES AND RESPONSIBILITIES:** + Assists study team lead with development and execution of trial activities, including development and maintenance of study timeline. + Communicates with sites to address protocol questions, escalating when necessary. Conveys protocol clarifications to sites. Conducts investigator and site qualification visits of selected community-based physicians. + Drafts study documents with assistance from more senior Clinical Project Coordinators (e.g., protocols, amendments, study plans, DSMB reports, grant submissions). + Assists in leading internal meetings, and monitors progress toward meeting team goals and completing action items. Drafts agendas and disseminates project information to all appropriate parties. + Oversees the development, collection and storage of regulatory documents and maintenance of trial master file. May oversee work of junior staff in this capacity. + Receives from sites and appropriately reports notices of serious adverse experiences, drug adjustments, drug disclosures, and study terminations. Other duties as assigned **QUALIFICATIONS:** + Bachelor’s degree required. + 2 years of relevant experience 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. + Clinical trials project management experience preferred. + CCRP - Certified Clinical Research Professional upon hire preferred. + Certified Project Management Professional (PMP)-PMI upon hire preferred. 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. **How To Apply** All applicants must apply online. _EOE Minorities/Females/Protected Veterans/Disabled_ **Pay Range** Pay Range: $63,815 - $95,723 Annually _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._ Apply for Job + Careers + Sign In + New User **Location:** School of Medicine & Dentistry **Full/Part Time:** Full-Time **Opening:** **Schedule:**