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, 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 — “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 operations

Proven track record of successful oversight of clinical trial operations, particularly in academic medical centers or healthcare institutions

Experience ensuring compliance with clinical trial billing regulations and familiarity with regulatory agencies

Strong leadership skills, with a proven ability to manage and inspire diverse teams, including directors, coordinators, and administrative staff

Strong problem-solving skills, with the ability to identify operational challenges and propose innovative solutions that enhance efficiency, compliance, and overall trial performance

Ability to think strategically about the long-term goals of clinical research operations and align resources and policies accordingly

Preferred Requirements and Qualifications

Doctorate or terminal degree

Experience specifically in non-oncology clinical trials is strongly preferred

Work Mode Designation

Pay Range :

The projected salary or hourly pay range for this position which represents the full range of anticipated compensation is :

80,429.00 - $157,238.93

Compensation is determined by a number of factors including, but not limited to, the candidate’s individual qualifications, experience, education, skills, and certifications, as well as the University’s business needs and external factors.

Current Georgetown Employees :

If you currently work at Georgetown University, please exit this website and login to GMS () using your Net ID and password. Then select the Career worklet on your GMS Home dashboard to view Jobs at Georgetown.

Submission Guidelines :

Please note that in order to be considered an applicant for any position at Georgetown University you must submit a resume for each position of interest for which you believe you are qualified. Documents are not kept on file for future positions.

Need Assistance :

Need some assistance with the application process? Please call 202-687-2500. For more information about the suite of benefits, professional development and community involvement opportunities that make up Georgetown's commitment to its employees, please visit the Georgetown Works .

EEO Statement :

Georgetown University is an fully dedicated to achieving a diverse faculty and staff. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, color, religion, national origin, age, sex (including pregnancy, gender identity and expression, and sexual orientation), disability status, protected veteran status, or any other characteristic

Benefits :

Georgetown University offers a comprehensive and competitive benefit package that includes medical, dental, vision, disability and life insurance, retirement savings, tuition assistance, work-life balance benefits, employee discounts and an array of voluntary insurance options. You can learn more about benefits and eligibility on the .

Salary : $80,429 - $157,239