Located in a historic neighborhood in the nation's capital, Georgetown offers rigorous academic programs, a global perspective, exciting ways to take advantage of Washington, D.C., and a commitment to social justice. Our community is a tight knit group of remarkable individuals interested in intellectual inquiry and making a difference in the world.

Requirements

As one of approximately 140 academic health and science centers 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.

The Clinical Research Coordinator II (CRCII) acts as the primary coordinator on multiple high-complexity clinical research studies, interacting directly with patients, research participants, and their families. S/he is responsible for the implementation of their assigned portfolio of studies, including but not limited to, Institutional Review Board (IRB) submissions and data abstraction/entry/management. Working under the direct supervision of the Research Director and conducting studies under direct oversight of the Principal Investigators (PIs), the Clinical Research Coordinator II has additional duties that include but are not limited to:

• Maintains consistent and clear communication with Principal Investigators and sponsors/CROs.
• Identifies issues/problems and makes appropriate recommendations for compliance to research billing and research review of charges and collections appropriate to the clinical trial.
• Communicates with patients, families, medical staff, caregivers, and third party payers about financial responsibility for all aspects of the medical regimen as necessary.
• Obtains appropriate financial responsibility forms and reconciles charges to third party payers versus clinical trials.
• Identifies and screens potential research participants to determine initial eligibility and interest in participation while maintaining privacy protections.
• Vets eligibility with the PI or Sub-Investigator prior to enrollment, consenting participants according to MGUH policy as well protocol guidelines.
• Conducts the sponsor closeout visit and completes regulatory closeout including IRB closure and drug/device/supply/equipment return, ensuring records are retained per institutional policy.
• Responds to all pages regarding screening and possible enrollment in clinical trails.
• Rotates in the CTTM research call schedule to support 24 hours a day/7 days a week coverage of clinical trials and biorepository work.
• Assures adequate training has occurred and is documented to staff the call rotation under the direction of the Director.
• Develops study job aides, checklists and source documents as needed to assure protocol compliance.

Qualifications

• Bachelor's degree in a scientific or related field
• At least 3 years CRCI or equivalent clinical research experience; an equivalent combination of education and experience may be substituted
• Working knowledge of the federal regulations and federal agencies including the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP)
• Familiarity with the International Conference on Harmonisation Guideline for Good Clinical Practice (ICH GCP)
• Strong organizational, critical thinking, and problem-solving skills
• Working knowledge of clinical trials contracting and budgeting, including an understanding of medicare coverage analysis (MCA) and clinical trials billing compliance, both industry and non-industry
• Excellent demonstrated interpersonal, verbal, and written communication skills
• Strong proficiency in Microsoft, google, data capture systems, electronic medical records, and other computer applications

Preferred

• Experience with OnCore (Clinical Trials Management System)
• Certified clinical research certification (SoCRA or ACRP) preferred and required within one year of eligibility