GENERAL PURPOSE:

　　Plans, directs and coordinates clinical studies ranging from phases I through IV to be compliant with FDA and NIH requirement, as needed. Manages multi-center and single center clinical studies and trials with extensive responsibility for staff supervision, oversight of study startup, maintenance and closeout activities, SOPs, training, and regulatory compliance with considerable latitude for the exercise of independent judgement and initiative.

　　JOB DUTIES AND RESPONSIBILITIES:

　　Plans and implements study management for research projects to ensure objectives outlined in the project will be accomplished in accordance with prescribed priorities, time limitations, and funding conditions through initiation and oversight of team meetings and activities.

　　Supervises and ensures study operations comply with government reporting and funding regulatory requirements including preparation of study activities, protocol, consents, SOPs, INDs and IDEs

　　Coordinates administrative efforts and trains investigators and coordinators at participating centers. Supervises on-site monitoring of participating centers, if applicable.

　　Plans and implements a comprehensive data management and information systems in conjunction with the IT/computer programming staff. Develops eCRFs and assists with data collection, data reports, and analysis.

　　Initiates and participates in meetings, evaluates enrolling centers, and confers with sponsor, regulatory agencies, IRBs and University administration.

　　Hires, trains, supervises, and evaluates CCRC staff with regard to performance and study responsibilities.

　　Maintains a good working knowledge of the cardiovascular research literature and regulatory compliance issues both in general and as it relates to the specific tasks assigned through attendance at national meetings and interactions with study sponsors.

　　QUALIFICATIONS:

　　Bachelor’s degree and 5 years of experience in clinical research, preferably management experience; or an equivalent combination of education and experience required.

　　5-7 years of experience in industry sponsored clinical research requiring FDA/ISO compliance highly preferred. Prefer clinical background in nursing or other clinical specialty.

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　　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: $75,650 - $113,464 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.

　　Location: School of Medicine & Dentistry

　　Full/Part Time: Full-Time

　　Opening: Full Time 40 hours Grade 055 CCRC

　　Schedule: 8:30 AM-5 PM