Rutgers, the State University of New Jersey is seeking a motivated Executive Director for the Clinical Trials Office (CTO) within the Rutgers Institute of Translation Medicine and Science. Reporting to Vice Chancellor for Translational Medicine and Science, the Executive Director will oversee the Clinical Trials Office and its team of highly skilled and efficient clinical research and administrative staff. The Executive Director will provide strategic leadership, administrative and fiscal oversight for the CTO, as well as, establishing standard operating procedures. Expectations for the Executive Director include continued focus on increasing efficiencies, improving quality control, and providing a robust training and education program.
Among the key duties of this position are the following:
In partnership with the Vice Chancellor for Clinical and Translational Science, and serving as the administrative partner of the leadership of Trial Acceleration and Recruitment Office (TARO-CTSA), the Regulatory Core (CTSA) and the CRC/CRU, the Executive Director is responsible for the development, implementation and oversight of activities to support the mission of the CTO.
Establishes the office's functions, responsibilities, workflows, website, and communications. Hires staff.
Directs managers/supervisors in various units within the CTO and establishes SOPS and operative standards, monitors progress and compliance; provides guidance and leadership to subordinates.
Oversees and ensures successful delivery and execution of clinical trials review, processing and set-up.
Oversees strategic planning, organizing and oversight of the CTO, including patient recruitment, compliance, performance and QA, operational efficiency and employee engagement.
Administrative management of electronic systems to enhance and monitor clinical trial activity (Deep6 AI and OnCore CTMS).
Provides timeline and general status updates to PIs and study teams.
Leads or assists with on-going reviews of internal processes to streamline or create more efficient processes.
Analyzes and documents clinical research business practices to develop strong electronic workflow and procedural documentation.
Works with other offices or departments to ensure compliance with sponsor requirements, streamline workflows, and improve processes.
Minimum Education and Experience:
Masters degree in a relevant field (MS/MBA/MHA) with a minimum of ten years (10) of clinical research experience, including experience coordinating and managing clinical research programs and ten years (10) of progressive leadership and management experience within a large healthcare or academic organization, is required.
Effective management experience and oversight of a large and diverse staff, demonstration of analytical experience, management of large-scale, highly visible projects and the ability to present information in person and in writing are essential for this position.
Required Knowledge, Skills, and Abilities:
Proven ability to successfully deliver a wide range of projects within critical time frames and within budget.
Outstanding leadership skills.
Strong understanding of policy and practice governing clinical research within a large institution.
Demonstrated ability to lead efforts, and accomplish change within the organization.
Outstanding people skills; proven ability to create, motivate, and oversee teams with diverse skills sets.
Knowledge of how to accomplish superior performance in a unionized environment.
Extensive knowledge in clinical research operations and associated regulations governing clinical research.
Strong communication skills (verbal and written)
Ability to make decisions with significant, broad implications for the management and operations of a major department or multiple departments.
Ability to address problems that are broad, complex and abstract, often involving RBHS-wide issues and requiring substantial creativity, resourcefulness, staff engagement.
Ability to communicate complex information in English effectively in writing to all levels of staff, management and external partners across functional areas.
Ability to lead collaborative teams for larger projects or groups both internal and external to RBHS and across functional areas.
Ability to lead operational initiatives to meet or exceed customer service standards and expectations in assigned unit(s) and/or across multiple areas in a timely and respectful manner.
Working knowledge of cross-functional areas associated with clinical development and operational execution of trials.
Proven track record of meeting organizational milestones, timelines, and working closely with teams to ensure clinical program objectives are met.
Self-motivated, detail-oriented and capable of handling significant responsibility as well as shifting priorities; exercises discretion; takes initiative to resolve problems.
Anticipates needs, responds quickly, provides guidance and support, monitors and follows up as required
Demonstrated ability to supervise and motivate professional and administrative support staff, including interviewing, selection, training, performance reviews and disciplinary action.
Clear experience of managing a large financial portfolio of industry-sponsored and non-industry sponsored clinical trials
Must have expert knowledge of clinical research, including: Medicare coverage analyses, clinical trials budgeting, contracting; management of trials and subject accrual/retention; and federal guidelines/regulations pertaining to clinical research.
Must have the ability to analyze complex administrative and financial data, create reports and craft effective solutions to both long- and short-term problems.
Must have a passion for excellent customer service and commitment.
Bachelor of Science in Nursing, Business Management or equivalent.
Master’s in Organization, in Science or in Business with or without a CPA.
Certification in clinical research (CCRP, CCRC, CHRC, etc.)
Experience with Epic EHR system and OnCore CTMS.
Posting Number: 19ST4933
Location: Downtown New Brunswick
Internal Number: 106670
About Rutgers University
Rutgers, The State University of New Jersey, is a leading national public research university and the state's preeminent, comprehensive public institution of higher education. Rutgers is dedicated to teaching that meets the highest standards of excellence; to conducting research that breaks new ground; and to turning knowledge into solutions for local, national, and global communities. As it was at our founding in 1766, the heart of our mission is preparing students to become productive members of society and good citizens of the world. Rutgers teaches across the full educational spectrum: preschool to precollege; undergraduate to graduate and postdoctoral; and continuing education for professional and personal advancement. Rutgers is New Jersey's land-grant institution and one of the nation's foremost research universities, and as such, we educate, make discoveries, serve as an engine of economic growth, and generate ideas for improving people's lives.