Manager of Clinical Trials

GENERAL PURPOSE:.

Under general direction from the Program Administrator, and with considerable latitude for the exercise of independent judgment, manages the technical/administrative, financial, quality, and personnel management functions of the Clinical Trial Office. The Manager of Clinical Trials Research has final responsibility to faculty and administration for the functional performance of the clinical trials staff, adherence to regulatory and compliance governing bodies (internal/external); and fiscal management related to clinical trials studies under the Department of Urology.

SPECIFIC RESPONSIBILITIES:

• Oversees all human subject research activities across all patient care locations both in the ambulatory setting and surgical. Develops, implements and evaluates study subject requirement strategies, information and data systems and study management systems. Creates, plans, develops, implements and manages study design, budgets, protocols, consent forms, processes and policies that may include multiple therapeutic areas. Creates, develops, reviews and approves case report forms and study-specific procedures, manuals and documents.

• Represents sites, providers, study team, patients, study participants and the University to establish, develop, oversee, monitor and maintain working relationships, positive communications and effective results. Responsible for supporting the contacts and relationships between and among Principal Investigators (PI), clinical nursing staff, research staff, study sites and sponsoring and regulatory agencies.

• Manages research coordinators of various levels. Develops, delivers and monitors efficacy of training on the conducting of human subject research in accordance with approved protocols and in compliance with the Good Clinical Practices (GCPs), including training on policies and practices used by sponsors for the purpose of meeting regulatory requirements.

• Defines, develops, and oversees operational measures to ensure compliance with study protocols in accordance with both University and External regulatory standards. Possess the expertise to define study acuity levels and have the independent judgment to recommend and support standard operating procedures (SOP) to provide the necessary actions required to perform clinical trials for phase I, II, & III trials.

• Designs, develops, implements, monitors and manages systems and methods to ensure quality, safety, efficiency and consistency in the processing of data. Reviews study progress, including data, finances, timeframes, documentation and reporting deliverables. Manages, implements and monitors systems for tracking and evaluating study progression.

• Keeps current with all federal, state, sponsor and institutional policies and laws, SOPs and guidelines. Manages and evaluates resulting study changes. Demonstrates accountability for continuous learning in accordance with GCPs. Keeps current with industry standards, best practices and trends in therapeutic areas relevant to research studies.

Other duties as assigned

REQUIREMENTS:

• Bachelor’s degree required

• Licensed and registered by the New York State Education Department (NYSED) as a registered professional nurse (RN) preferred

• 5 years of experience in clinical research required

• or equivalent combination of education and experience required

• Experience as Sr. Human Subject Research Coordinator preferred

• Word processing and data analysis software required

• Professional Research Coordination certification (SoCRA or ACRP) 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: $68,400 - $102,600 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 Urology M&D