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Job Location (Full Address):

220 Hutchison Rd, Rochester, New York, United States of America, 14620

Opening:

Worker Subtype:

Regular

Time Type:

Full time

Scheduled Weekly Hours:

40

Department:

910088 Pediatrics Neonatology

Work Shift:

UR - Day (United States of America)

Range:

UR URG 113

Compensation Range:

$77,216.00 - $115,824.00

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

Directs and coordinates all aspects of clinical research trials and acts as a liaison to study leadership and sponsor(s). Ensures study activities are meeting deadlines and manages overall study timeline. Provides oversight and mentoring to junior members of the study team in addition to manages senior members of the team in a supervisory capacity.

ESSENTIAL FUNCTIONS

• Directs the development and execution of clinical trial activities for multi-center industry sponsored trials, including developing and revising study timelines. Engages with Finance for budget development and budget management. May be asked to manage more complex protocols and/or larger scale industry sponsored trials.

• Mentors, trains, and manages staff, including developing career plans and delivering performance appraisals.

• Leads internal and external meetings and provides professional direction within clinical trials team. Monitors progress toward meeting team goals and completing action items.

• Serves as liaison to the Principal Investigator, study leadership, vendors, and sponsor. Oversees entire study team, internal and external, including clinical trial sites, clinical and research laboratories, study medical monitors, biostatistics core, and data management team. Represents study team in meetings.

• Drafts and/or completes internal review of study protocol and final study documents for review and approval by study leadership. Drafts requests and reports to regulatory agencies, such as IND application, annual IND update to FDA, etc.

• Plans large scale external meetings. Presents at external study meetings as well as other professional meetings.

Other duties as assigned.

MINIMUM EDUCATION & EXPERIENCE

• Bachelor's degree and 6 years of relevant experience required

• Master's degree preferred

• Or equivalent combination of education and experience

• Previous leadership experience required

KNOWLEDGE, SKILLS AND ABILITIES

• Clinical trials project management experience including extensive knowledge of protocol planning, implementation, coordination, evaluation, and reporting of clinical trials required

• Strong communication skills, interpersonal skills, attention to detail, and organization skills required

LICENSES AND CERTIFICATIONS

• 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 an inclusive and welcoming culture 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 characteristic protected by federal, state, or local law (Protected Classes). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates for all persons consistent with our values and based on applicable law.

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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.