Director, Office of Clinical Research
Oversees clinical research operational tracking, including observational and interventional clinical research studies. Advances the operations and business practices for studies, significantly evolves the organization’s infrastructure and capacity to conduct national, multi-site clinical trials and clinical research. Ensures research is conducted in accordance with all governing laws, regulations and ethical standards. Responsible for integration of institutional support services and stakeholders. Evaluates the viability and appropriateness of proposed trials at the time of study submission (e.g., projected enrollment, finances, and strategic value); reports on clinical research activities (including maintenance of necessary databases). Coordinates with other partners and stakeholders.
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.
Works with stakeholders and University committees to maintain policies for governance of clinical research. 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. 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/nogo 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.
Other duties as assigned
Bachelor’s degree in Business or health related field required
Master’s or PhD preferred
10 years of clinical research administration experience, including 5 years of experience designing, leading and/or managing clinical research studies or clinical research teams required
4 years of managerial experience required
or equivalent combination of education and experience required
Knowledge of research administration, Good Clinical Practice (GCP) and clinical trials required
Substantial knowledge and understanding of federal regulations affecting clinical trials and medical research preferred
Comprehensive skills and training in clinical research and business administration, including financial management, personnel administration, program planning, development and implementation preferred
Knowledge of Clinical Trial Management System (e.g. Velos, OnCore, OpenClinica) software 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: $120,600 - $180,900 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 057 Clin & Trans Science Institute
Schedule: 8 AM-5 PM