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University of Rochester Director, Office of Clinical Research - 226477 in Rochester, New York

Director, Office of Clinical Research Job ID 226477

Location

School of Medicine & Dentistry

Full/Part Time Full-Time

Favorite Job

Regular/Temporary Regular

Opening

Full Time 40 hours Grade 057 Clin & Trans Science Institute

Schedule

8 AM-5 PM

Responsibilities

GENERAL PURPOSE:

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 across the institution.

SPECIFIC RESPONSIBILITIES:

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.

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.

Develops or implements 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.

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. Provides operational leadership and effective management for the Office of Clinical Research (OCR).

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. 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.

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.

Oversees OCR analysis of study protocols, contracts and budgets to ensure regulatory compliance and fiscal sustainability.

Other projects and job duties as needed.

REQUIREMENTS:

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

At least 4 years of demonstrated leadership and managerial experience.

Knowledge of research administration, Good Clinical Practice (GCP) and clinical trials

Substantial knowledge and understanding of federal regulations affecting clinical trials and medical research preferred.

Strong presentation, interpersonal, and communication skills, including strong writing ability.

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

Prior project management experience desirable

Equal Opportunity: Respect for each individual is fundamental, and diversity within the University community advances the University's Mission to Learn, Discover, Heal, Create – and Make the World Ever Better. The University is committed to the goals of equal employment opportunity as supportive of University values and those of our society. The University is committed to selecting 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. In recruitment, the University makes special efforts to solicit the candidacy of underrepresented group members, veterans, and disabled persons, in furtherance of its Affirmative Action obligations. The University complies with all applicable non-discrimination laws in the administration of its policies, admissions, employment, and access to and treatment in University programs and activities.

How To Apply

All applicants must apply online.

EOE Minorities/Females/Protected Veterans/Disabled

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