The Executive Director of Clinical Research Operations reports to the Chief Academic Officer of BIDMC/BILH responsible for the developing and sustaining a compelling vision for how to address the current and future needs of human investigation at BIDMC. Responsible for administrative and fiscal management of the following functions: the Institutional Review Board, Clinical Trials Office, Clinical Research Center, Human Subjects Protection Office and clinical research activities in different departments. Responsible for continuing AAHRPP accreditation. Works closely with the Vice President for Research Operations on budgeting and personnel matters. Direct reports to this position are: Director of Clinical Trials Office, Director of Human Subjects Protection Program, Director of Clinical Research Programs and the Chair of the IRB. Requires close collaboration and development of strategic alliances with other operational units of BIDMC/BILH to represent the unique needs of research in the organization including the clinical system, clinical leaders, nursing, pharmacy, information technology, compliance and regulatory agencies. BIDMC is also a member of the Harvard Medical School Catalyst and interface and collaborations with the Catalyst is an important element of the Director's responsibilities. Serves as the Institutional Official for our Human Research Protection Program (HRPP).
Manage a fiscally responsible and efficient clinical research administrative operation. Adjust budgets and personnel to facilitate timely implementation of the InSPIRE BIDMC academic strategic plan.
Implement best practices and apply new standards to clinical research operations. Maintaining AAHRPP accreditation.
Create and maintain a service-oriented culture. Develop a high-performing clinical research team.
Develop budgets that tie resources to performance priority areas. Relate clinical research's financial operation to the larger financial operation at BIDMC and BILH.
Serve as clinical research administration's liaison to BIDMC's operational departments and represent Clinical Research on BIDMC's committees.
Work closely with the Clinical and Research Information Technology teams to improve infrastructure and access to EMR-based research.
Working with the CAO and Department Chairs, create a Biostatistical Core in support of clinical research.
Design and implement action plans for strategies developed by the CAO.
Represent BIDMC in collaborative efforts with neighboring organizations in the Longwood Medical Area including Harvard Catalyst and the Dana Farber Harvard Cancer Center.
Has the authority to direct and support employees daily work activities. Has the direct responsibility to undertake the following employment actions: hiring, termination, corrective action and performance reviews. Direct Reports: None Indirect Reports: None
Has full responsibility for planning, monitoring and managing department budget.
Master's degree in Healthcare or Business Administration, Science or related degree. required.
5-8 years related work experience required and 1-3 years supervisory/management experience required
More than 5 years related work experience required within a clinical research setting, preferably within an academic medical center serving strong, independent and innovative clinical researchers.
Demonstrated experience with all aspects of clinical research management including human subjects research, clinical research unit organization, clinical research coordinator and nursing, billing regulations related to research and clinical charges, research pharmacy, FDA and other reporting requirements.
Understanding of the financial elements of clinical research and its relation to standard of care clinical billing, compliance with the funding requirements of government agencies and private industry, and handling of direct cost negotiations with sponsors.
Advanced skills with Microsoft applications which may include Outlook, Word, Excel, PowerPoint or Access and other web-based applications. May produce complex documents, perform analysis and maintain databases.
Internal Number: 40209BR
About Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center (BIDMC) is part of Beth Israel Lahey Health, a new health care system that brings together academic medical centers and teaching hospitals, community and specialty hospitals, more than 4,000 physicians and 35,000 employees in a shared mission to expand access to great care and advance the science and practice of medicine through groundbreaking research and education.
BIDMC is a world-class teaching hospital of Harvard Medical School and is located in the heart of Boston.
We are passionate about caring for our patients like they are family, finding new cures, using the finest and the latest technologies, and teaching and inspiring caregivers of tomorrow. We put people at the center of everything we do, because we believe in medicine that puts people first.