Director of Clinical Research

The University of Rochester envisions itself as a community that welcomes, encourages, and supports individuals who desire to contribute to and benefit from the institution’s missions of teaching, research, patient care, performance, and community service. As a community, we are 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 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.

The University of Rochester’s Clinical and Translational Science Institute (CTSI) supports research teams to help them produce results better and faster – to ultimately improve the health of communities and populations. Our Vision is to cultivate a diverse and inclusive environment that guides and transforms our approaches to healthcare, education, research and community partnerships. Since its inception in 2006, the UR CTSI has invested over $20 million in research funding and trainee support at the University of Rochester through its commitment to funding innovative, early-stage research.

CTSI’s vision is to build a sustainable model for research across the translational spectrum that is responsive to community priorities and improves population health, conducted by transdisciplinary, patient and community-engaged teams. In support of that vision, CTSI is in search of an innovator to lead the Office of Clinical Research as its Director.

The Director of Clinical Research will evolve CTSI’s infrastructure and capacity to conduct national, multi-site clinical trials and clinical research, collaborating with partners and stakeholders across the institution. This will include evaluating the viability of proposed trials (e.g., projected enrollment, finances, and strategic value), and operational oversight of observational and interventional clinical research studies. The Director of Clinical Research will be a steward of high quality and ethical clinical research which enhances the scientific reputation of the University both nationally and internationally.

Primary responsibilities include:

  • Provides oversight and institution-level coordination of clinical research activities, with a focus on clinical trials, ensuring compliance with established federal, state, local and institutional guidelines.
  • Implements processes and procedures to improve compliance and the programmatic and fiscal integrity of clinical trials and research activities. Communicates with institutional stakeholders, investigators, research staff and study sponsors to facilitate research activities.
  • Develops a business model and staffing structure to support high-quality clinical research, with a defined fee structure to partially offset costs. Monitors billing and financial operations for active clinical research trials, including routine stakeholder reporting, to ensure trials are operating effectively.
  • Evaluates and delivers new services and operational capabilities to reflect investigator interests, institutional goals, sponsor needs and the evolving scientific landscape. Assists with professional education programs to train and mentor study coordinators and investigators on how to conduct ethical and effective clinical research studies.

EOE Minorities/Females/Protected Veterans/Disabled

CTSI embraces the importance and benefit of fostering a diverse research workforce. We are committed to creating an inclusive and welcoming environment for all. As part of the University of Rochester Medical Center, the UR CTSI wholeheartedly subscribes to the center’s ICARE values: Integrity, Inclusion, Compassion, Accountability, Respect and Excellence.…

Qualifications: Experience

  • 10 years of Clinical Research administration experience, including 5 years of experience leading and/or managing clinical research studies or clinical research teams.
  • Comprehensive experience in clinical research administration, including financial management, personnel administration, program planning, development and implementation. • Knowledge of Good Clinical Practice (GCP) and federal regulations affecting clinical trials and medical research.
  • Knowledge of Clinical Trial Management System (e.g. Velos, OnCore, OpenClinica) software preferred
  • Bachelor’s degree in Business or Health related field required. Master’s or PhD preferred.

Qualifications: Education
Bachelor’s degree

How to apply
Job ID: 226477
HRMS Direct Apply Link:…

Application Instructions
Applications and resumes must be submitted online.
REF JOB ID: 226477
HRMS Direct Apply Link:…