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Virginia Commonwealth University is seeking a dynamic Director of Clinical Research Operations and Management for the Massey Cancer Center’s Clinical Trials Office (CTO). Reporting to the Chief Administrative Officer (CAO) and working closely with the Medical Director of the Clinical Trials Office (CTO), this position provides constructive and forward-thinking administrative leadership for the VCU Massey Cancer Center (MCC) CTO. The Director is responsible for the executive oversight, management, planning and direction of all clinical research operational areas, to include, but not limited to: nursing and data management, protocol development and project management, regulatory affairs, compliance, monitoring and auditing, and education/training for clinical research professional staff. This highly visible role includes responsibility and accountability for continually improving the quality and efficiency of the clinical trials office. This position, along with the CAO and CTO Medical Director, provides significant contribution to the operational success of the Cancer Center in fully realizing its research mission and strategic initiative to retain NCI designation and reach the goal of NCI comprehensive designation.
Through the oversight and management of the CTO activities, the Director of Clinical Research Operations and Management will be responsible for providing supervision of clinical research initiatives underway at MCC, ensuring compliance with established federal, state, local and institutional guidelines and regulations governing the conduct of clinical research; implementing processes and procedures to improve compliance, insuring the programmatic integrity of clinical research; effectively communicating with the center’s senior leadership, investigators, research staff and representatives of study sponsors to facilitate the activation and conduct of clinical trials in a highly collaborative and matrix environment. He/she will use research-driven performance measures and assess complex situations to research-driven criteria, in order to plan strategically and flexibly, and respond tactically and resourcefully. This position will ensure expert management control, and will provide strategic oversight for clinical trials research operations, data management, regulatory compliance, quality assurance and safety, as well as the integration of research into clinical operations. He/she will be responsible for assigned projects, with optimal efficiency, through effective performance, leadership and development of his/her staff.
This position works across the organization and will be responsible for promoting a customer friendly environment and providing superior service to our patients, students, faculty, and employees, as well as other stakeholders.
Extensive experience (seven years or more) of progressively responsible experience in clinical trials operations and a minimum of five years clinical research leadership responsibilities in a complex academic/research environment
Extensive experience in managing large clinical trials and/or research operation. Prior oncology clinical research supervisory/management experience in an NCI-designated cancer center or equivalent large specialized academic institution.
Prior experience as a senior level supervisor, providing multiple functional area oversight and timely execution of deliverables, with demonstrated organizational, project planning and time management skills
Demonstrated quantitative and qualitative data analysis skills with ability to synthesize aggregate data into meaningful operational metric and benchmarking reports
Demonstrated decision making, creative problem solving, conflict resolution, and team building skills to build, lead, manage and mentor professional staff and build empowered employee led teams
Proven ability to work independently and to lead a multidisciplinary trial team in a complex matrix environment
Highly collaborative management style and skills including ability to collaborate with and build/maintain relationships with internal and external stakeholders across functions, to optimize performance and drive projects to completion.
Demonstrated experience working in and fostering a diverse faculty, staff, and student environment or a commitment to do so as a staff member at VCU.
Demonstrated ability to work well in a demanding, fast paced, sometimes ambiguous environment with exceptional skill for managing competing priorities; ability to prioritize, manage multiple functions, anticipate and identify conflicts, effectively problem solve using critical thinking skills, and meet deadlines
Preferred: Registered Nurse desired. ONS certification highly preferred. Professional certification in clinical research management or research administration required; such as CCRP, ACRP, or other related credentials. Knowledge of pharmaceutical studies, cooperative group processes and investigator-initiated research strongly preferred. Specialized knowledge of the unique needs of patients undergoing treatment in clinical trials strongly preferred.
Internal Number: FAE140
About VCU Massey Cancer Center
About VCU Massey Cancer Center:Founded in 1974, VCU Massey Cancer Center is a non-profit organization part of Virginia Commonwealth University, one of the nation’s top research universities, and VCU Medical Center, a leading academic health system ranked Virginia’s top hospital by U.S. News & World Report in 2013.We are one of only 67 among 1,500 cancer centers in the country, and one of only two in Virginia, designated by the National Cancer Institute. Placing us among the top 4 percent of cancer centers in the country, NCI designation means we are leading and shaping America’s fight against cancer.We are a vital resource for cancer research, treatment and clinical trials as well as training of the region’s oncologists.http://massey.vcu.edu/news/about/facts/About VCU and VCU Medical Center: Virginia Commonwealth University is the largest university in Virginia and ranks among the top 100 universities in the country in sponsored research. Located on two downtown campuses in Richmond, VCU enrolls nearly 32,000 students in 205 certificate and degree programs in the arts, sciences and humanities. Sixty-five of the programs are unique in Virginia, many of them crossing the disciplines ...of VCU’s 15 schools and one college. MCV Hospitals and the health sciences schools of Virginia Commonwealth University compose the VCU Medical Center, one of the nation’s leading academic medical centers. For more information, see www.vcu.edu. The VCU Medical Center is a comprehensive academic medical center with Schools of Allied Health Professions, Dentistry, Medicine, Nursing, Pharmacy, and developing school of public health.