NYU Langone Medical Center, a world-class, patient-centered, integrated, academic medical center, is one of the nation's premier centers for excellence in clinical care, biomedical research and medical education. Located in the heart of Manhattan, NYU Langone is composed of four hospitals - Tisch Hospital, its flagship acute care facility; Rusk Rehabilitation; the Hospital for Joint Diseases, one of only five hospitals in the nation dedicated to orthopaedics and rheumatology; and Hassenfeld Children's Hospital, a comprehensive pediatric hospital supporting a full array of children's health services across the medical center - plus the NYU School of Medicine, which since 1841 has trained thousands of physicians and scientists who have helped to shape the course of medical history. The medical center's tri-fold mission to serve, teach and discover is achieved 365 days a year through the seamless integration of a culture devoted to excellence in patient care, education and research. For more information, go to www.NYULMC.org.
We have an exciting opportunity to join our team as a Director Clinical Research Support-OSR.
In this role, the successful candidate will work in the Clinical Research Support (OCRS) at the NYU Langone Medical Center (NYULMC). The OCRS office is in charge of providing pre and post award administrative support of human subject research, including trials for pharmaceutical products and medical devices. The Director is responsible for providing overall administrative leadership, strategic planning, and operational management. He/she will work closely with clinical research leaders at NYULMC to manage and oversee the growth and development of the clinical research mission. The incumbent in this position needs to ensure that NYULMC is compliant with clinical research policies and regulations, while successfully achieving its goals of maintaining high standards, as well as manage resources, processes and performance.
• Lead the development of strategic goals for the growth and development of the clinical research program in support of the overall vision and mission of NYULMC.
• Oversee the implementation of these goals and actively monitor progress toward goals.
• Work collaboratively with peers in the development of the budget for the office and oversee the allocation of discretionary resources.
• Provide leadership, guidance, training and recognition for staff in other clinical research related committees.
• Promote close interactions between clinical scientists in collaboration with program leaders and administrative leadership
• Ensure that internal processes and Standard Operating Procedure (SOPs) are updated and followed according to Good Clinical Practice (GCP) and relevant federal guidelines.
• Manage the Standard Operating Procedures/Standard Work Procedures for the office and research community.
• Assist in establishing metrics to measure and evaluate project progress, performance and costs, and make recommendations for improvement.
• Define policies, procedures, training and documentation requirements to support timely process and policy changes.
• Provide direction, leadership, and financial oversight in the management and execution of clinical trials.
• Supervise OCRS staff including Associate Director, Financial Manager, Clinical Research Operations Specialists, and Clinical Research Administrative staff in performance of duties.
• Oversee the negotiation and timely processing of research contracts and contract amendments.
• Responsible for review and approval of research studies, billing compliance and oversight, as well as to provide faculty and staff with budget and billing information and education on research compliance procedures.
• Oversee the planning, scheduling, and coordination of detailed administrative matters related to funded and planned clinical research projects.
• Align community clinical research operations and stakeholders with institutional initiatives.
• Serves as the business owner for the clinical research management system.
• Perform other duties as assigned.
To qualify you must have a Bachelor's degree in addition to a minimum of 10+ years of clinical research and/or related experience. At least 5 years supervisory and management experience. Process improvement experience. Excellent written and verbal communication skills are essential, including the ability to write reports and business correspondence. Working knowledge of the Common Rule (45 CFR 46), the Privacy Rule (45 CFR 160, 164) and the regulations that govern human subjects research issued by the Food and Drug Administration (21 CFR 50, 56), and other regulations as needed. Strong understanding of current standards for Good Clinical Practice (GCP) guidelines defined by the International Committee on Harmonization, FDA, NCI/NIH, OHRP, and the Office of Civil Rights, and according to state and institutional regulations. Demonstrate strong knowledge of CMS/Medicare coverage requirements. Apply broad technical knowledge and sound judgment in clinical and administrative decisions. Experience with legal language (contracts, confidentiality agreements, etc.), financial (budgetary) costing and accounting principles. Ability to analyze and prepare clinical study costing tools. Working knowledge of all types of clinical trial sponsors: federal grants and sub-awards, foundations, investigator initiated trials and industry funded. Ability to clearly develop action plans that meet the institutions strategies, goals and clinical development plans. Must demonstrate self motivation, a winning attitude, be a team player and have strong interpersonal skills. Must display strong analytical and problem solving skills. Attention of detail is required.
Master's degree in business and healthcare administration or other related field. A minimum of 10 years of clinical operations experience with thorough understanding of cross functional clinical processes, including data management,
biostatistics, and medical writing. Prior experience with design, roll out and implementation of Clinical trial management systems (CTMS/CRMS). Prior experience leading a team through a period of reorganization or dramatic change. Familiarity with EPIC EMR. Action oriented, functional/technical skills, Interpersonal skills, Organizational skills, Analytical skills, Time management, and written communications. Respects diversity.
Qualified candidates must be able to effectively communicate with all levels of the organization.