Washington University School of Medicine, Department of Neurology, seeks an experienced clinical research administrator to play a key role in managing a pioneering clinical trials infrastructure studying changes in people who carry an Alzheimer’s disease mutation.
The Dominantly Inherited Alzheimer’s Network-Therapeutic Trials Unit (DIAN-TTU) is an international network, established by the National Institute on Aging of the National Institutes of Health, that brings together 11 research centers to conduct the first ever clinical trial testing of experimental drug therapies within a global network of individuals who have a rare form of Alzheimer’s disease, but have not yet experienced the onset of symptoms.
The Associate Director Research Clinical Trials Operations is responsible for the operational planning and execution of multiple Phase II – III global/international studies from protocol concept through the clinical study report.
These responsibilities include, but are not limited to:
Collaboration with all relevant groups (Trial Sponsors, Trial Project Leaders, Administrative Operations, Cores/Components, CRO/ADCS, performance sites) to develop and manage clinical project timelines.
Disseminating clinical project communication to all functional groups as appropriate.
Contributing to protocol synopsis development and Clinical Operations feasibility assessments.
Writing study protocols, amendments and administrative changes based on approved protocol synopsis.
Participating in the selection and oversight of CRO and clinical vendors/components (biomarkers, imaging, data management).
Planning and participation in investigator meetings in collaboration with all cross-functional team members.
Ensuring the training of Trial Project Leaders, performance sites and Cores/Components on the protocol and expectations of the study.
Partnering with Administrative Operations, Project Leaders, CRO, and/or vendors for resolution of corrective actions as a result of QA audit and/or regulatory inspections.
Collaborating with Sponsors to ensure appropriate and timely drug supply for assigned studies.
Qualified candidates will have a bachelor's degree or RN with a minimum of 10 to 15 years of experience in clinical research including at least one year of industry experience in a sponsor role with significant leadership and management experience.
For over a century, Washington University School of Medicine has been consistently recognized as one of the country's premier medical schools and is one of the largest recipients of funding for research and training from the National Institutes of Health with more than $531 million supporting faculty research efforts. Nineteen Nobel laureates have been associated with the School of Medicine. Elev...en of its present faculty members have been elected to the National Academy of Sciences and 25 members belong to its Institute of Medicine. The School of Medicine teaches an exceptionally strong student body of over 1,300 students and ranks first in the nation in the entering scores of its medical school classes. It also attracts an exceptional group of residents and fellows and has the largest and one of the finest MD/PhD programs in the country.