Clinical Research Coordinator - Medical Center

Clinical Research Coordinator 2 - Medical Center

Georgetown University |

Georgetown University | Posted Feb 23

Full-time

Washington

Unknown

Negotiable

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.

The Clinical Research Coordinator 2 (CRC2) is responsible for managing and coordinating the ALL ALS studies, primarily in the disease states of Neuromuscular Disorders (ALS). Coordination and management of such studies is both a dynamic and demanding responsibility that requires refined technical, organization, interpersonal, and coordination skills. The CRC2 is responsible for learning the schedule of assessments for each trial, and for coordinating each visit, which involves extensive preparatory work/pre-visit planning described in the “Responsibilities” section.

At the time of the visit, the CRC2 is responsible for conducting the entire study visit for each patient, ensuring that the protocol is followed, which requires an in-depth understanding of the intricacies of each individual protocol and patient needs. The CRC2 must maintain a comprehensive functional knowledge of the ancillary departments to be involved in trial visits (e.g., Radiology, CRU) and must be able to communicate and coordinate with such departments effectively.

The CRC2 must be capable of performing his/her job maintaining patient confidentiality at all times, and must adhere to the university requirements for the conduct of clinical research. The CRC2 for this position will is responsible for coordinating the ALL ALS studies which will be conducted at the Georgetown University Hospital Dept. of Neurology main site and with remote patients.

The CRC2 will spend 5 days per week on site for these trials. This is a new national natural history/biobanking study with 35 sites around the country. The coordinator will interreact with other coordinators around the country on regular meetings and follow a central IRB protocol for all sites. It is not a treatment or blinded study.

• Regulatory maintenance
• Adherence with ongoing training requirements
• Accurate reporting of clinical trial visits via the OnCore/CTMS system
• Accurate and timely data entry
• Accurate and timely reporting of adverse events
• Timely communication with team members and clinical trial sponsors.

As an employee of Georgetown University, the CRC2 directly supports the University’s mission of cura personalis. Clinical Trials offer a unique opportunity for a patient to receive personalized and comprehensive care in a manner that they may not experience otherwise as a patient. Per the requirements of each clinical trial protocol, the CRC2 is required to be the main point of contact for a patient in a clinical trial and must respond to inquiries from any patient within 24 hours.

The CRC2 is instructed and required to maintain regular contact with each patient in their respective trials, because it is an FDA requirement to report adverse events in a timely manner, no matter the severity. As such, clinical trial patients develop close relationships with the CTM/CRC for a trial, which provides unprecedented access to care when necessary. In the overall scheme of the Georgetown…