Clinical Trials Proj Mgr II

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

400981 Neuro-Ctr Health & Tech/CTCC

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:

Coordinates all aspects of clinical research trials. 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.

Essential Functions

• Assists study team 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, such as protocols, amendments, study plans, DSMB reports, and 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 others within this capacity.
• Receives notices of serious adverse experiences, drug adjustments, drug disclosures, and study terminations from sites and appropriately reports.
  
  

Other duties as assigned.

Minimum Education & Experience

• Bachelor's degree and 2 years of relevant experience required
• Or equivalent combination of education and experience
• Clinical trials project management experience preferred
  
  

Knowledge, Skills And Abilities

• 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
  
  

LICENSES AND CERTIFICATIONS

• 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.