Search for Jobs

1 Result
University of Rochester - Clinical & Translational Science Institute
Rochester, NY, United States (on-site)
21 days ago
University of Rochester - Clinical & Translational Science Institute
Rochester, New York, United States (on-site)
21 days ago

Description

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 the Office 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 the Office 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:

  • Develops a business model and staffing structure to support high-quality clinical research, with a defined fee structure to partially offset costs.  Manages and determines appropriate staffing and skill to adequately administer the OCR core functions. Develops and implements strategies to continuously improve employee engagement.  Monitors billing and financial operations for active clinical research trials, including routine stakeholder reporting, to ensure trials are not operating in unplanned/unapproved deficits. Oversees OCR analysis of study protocols, contracts and budgets to ensure regulatory compliance and fiscal sustainability. 
  • Coordinates clinical research operations, working in partnership with existing structures (e.g., OHSP, CTSI, ORPA) to ensure high quality and ethical clinical research is conducted within an environment enhances the scientific reputation of the University both nationally and internationally. Monitors and supports clinical research activities throughout the entire research lifecycle: from initial research capacity requests from sponsors and their CRO representatives to negotiation to initiation, operation and close-out activities.  Ensures that studies proceed according to timelines, including (as necessary) IRB submission, study initiation and progression, data collection and reporting, as well as study closeout activities. Serves as a resource for principal investigators, study coordinators and study sponsors. Serves as liaison for internal and external vendors. Conducts presentations to sponsors and organizations and participates in meetings and task forces pertinent to conducting clinical research. 
  • Oversees development and implementation of education and training programs for staff and physicians involved in clinical research, in partnership with CTSI, OHSP, ORPA and the Center for Experiential Learning (CEL), including federal regulations, approved policies, standard financial management, protection of human subjects and the ethical conduct in research. Assists with professional education programs to train and mentor study coordinators and investigators on how to conduct ethical and effective clinical research studies. Monitors sponsor and investigator satisfaction with metric-driven approaches.
  • Oversees development and implementation of an OCR-managed study feasibility assessment process. Works closely with stakeholders, including OCR Research Feasibility Analyst, stakeholders from departments conducting clinical research and the SMD Finance team. This crucial enterprise process will further enable University leadership to make data-driven go/no go decisions with knowledge of needed institutional resources and awareness of potential institutional risks. Identifies, evaluates, develops and delivers new services and operational capabilities to reflect investigator interests, institutional goals, sponsor needs, industry standards and the evolving scientific landscape.


Requirements

  • 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

Job ID: 245208

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 will select faculty and staff without regard to 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 non-discrimination in 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.

Job Information

  • Job ID: 69156724
  • Workplace Type: On-Site
  • Location:
    Rochester, New York, United States
  • Company Name For Job: University of Rochester - Clinical & Translational Science Institute
  • Position Title: Director of the Office of Clinical Research
  • Job Function: Director / Assistant Director
  • Job Type: Full-Time
  • Job Duration: Indefinite
  • Min Education: BA/BS/Undergraduate
  • Min Experience: Over 10 Years
  • Required Travel: 0-10%
Rochester , US

The University of Rochester’s mission is to Learn, Discover, Heal, Create—and Make the World Ever Better. One of the world’s leading research universities, the University of 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. The University of Rochester Medical Center (URMC) is one of the nation’s leading academic medical centers, forming the centerpiece of the University’s heal...

View Full Profile

Jobs You May Like
Filters
Workplace Type
Job Function
Industry
State