Senior Director of Clinical Research Administration - Georgetown University Medical Center

Georgetown University comprises two unique campuses in the nation’s capital. With the Hilltop Campus located in the heart of the historic Georgetown neighborhood, and the Capitol Campus, just minutes from the U.S. Capitol and U.S. Supreme Court, Georgetown University offers rigorous academic programs, a global perspective, and unparalleled opportunities to engage with Washington, D.C. Our community is a close-knit group of remarkable individuals driven by intellectual inquiry, a commitment to social justice, and a shared dedication to making a difference in the world.

Requirements

As a top academic health and science center in the United States, Georgetown University Medical Center seeks to provide, in a synergistic fashion, excellence in education — training physicians, nurses and other health care professionals, as well as biomedical scientists — and cutting-edge interdisciplinary research collaboration, enhancing our basic science and translational biomedical research capacity in order to improve human health. Emphasizing service, we are dedicated to the Catholic, Jesuit principle of cura personalis — “care of the whole person.” Our partnerships with organizations in the region strengthen our work and expand its reach.

The Senior Director of Clinical Research Administration will be charged with the oversight of the administrative facets of clinical research for non-oncology clinical trials administered at Georgetown University Medical Center (GUMC). By providing this service, the goal is to strengthen existing processes to provide assurance to regulators and stakeholders that clinical trials meet the required standards for clinical trial billing and other applicable regulations. Duties include but are not limited to:

• Provide oversight of non-oncology clinical research operations staff, including directors and coordinators.

• Provide strategic planning and direct oversight of operations and research staff in the clinical research operations group.

• Serve as key operations liaison with all principal investigators (PIs) and promote a "service center “culture that ensures the research staff maximally serves the needs of investigators and research participants.

• Maintain an environment for clinical research that requires all research team members to be knowledgeable and compliant with all policies and regulations governing the conduct of clinical research billing.

• Communicate and implement new policies and procedures as well as applicable regulatory changes to non-oncology research teams.

• Establish processes that facilitate compliance and reinforce policy changes and regulatory requirements.

• Ensure protocol, subject records, and patient visit information in OnCore* are accurate and maintained in real-time and collaborate with the Senior Director of Clinical Research Finance to manage all system activities related to set-up, trial conduct, and closeout of clinical-trials subject records, and patient visit information in OnCore* is accurate and maintained in real-time.

• Collaborate with the Senior Director of Clinical Research Finance to manage all system activities related to the set-up, conduct, and closeout of clinical trials.

• Ensure per institutional policies that all clinical trials are added and regulated in CTMS (Clinical Trials Management System).

• Per institutional policy, track all research participants and any associated billing charges is enforced; Research billing and clinical care charges must be correctly associated, as necessary, to satisfy Georgetown policies and procedures and applicable federal regulations, including but not limited to, billing and regulatory compliance.

Work Interactions

This position reports directly to the Associate Vice President for Clinical Research Initiatives, who in-turn reports directly to the Vice President for Biomedical Graduate Education and Research. The incumbent provides direct oversight of non-oncology directors and research teams. The Senior Director of Clinical Research Administration collaborates closely with the Senior Director of Clinical Research Finance to optimize the workforce, enhance efficiency, ensure accurate information sharing and compliance, and provide the best possible care to research participants.

Requirements and Qualifications.

• Master's degree in a related field (e.g., Clinical Research, Public Health, Healthcare Administration, Life Sciences)

• Minimum of 10 years of experience in clinical research, including at least five years in a leadership or management role overseeing clinical operat