Position Primary Purpose and General Responsibilities 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 Medical Director of the Clinical Trials Office (CTO) and the Executive Director for Research Strategy, 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 CTO Medical Director and the Executive Director for Research Strategy, 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.
Minimum Hiring Standards
– 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 teambuilding 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 Hiring Standards Preferred: Registered Nurse desired.
ONS certification preferred.
Professional certification in clinical research management or research administration required; such as CCRP, ACRP, or other related credentials.
Professional certification in clinical research management or research administration; such as CCRP, ACRP, or other related credentials.
ONS certification highly preferred.
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.