Shannon Carr

Background

About Shannon Carr

Over 18 years of clinical research experience via Duke Clinical Research Institute. Served as a Project Leader. Over 20 years of data management, reporting and project management experience. • Effectively interfaced and served as a key site management trial team member to faculty, sub-contractors, sponsors, other functional groups, and study sites. • Multi-skilled professional managed multiple complex multi-site studies. • Ability to lead cross-functional project teams. • Trained project coordinators on self-developed project management tools and resources. • Served as an expert resource for clinical registry site start-up activities. • Highly skilled with the development and production of the Electronic Data Collection, and Patient Reported Outcomes (PROs and clinical site) tools to ensure the project goals and data standards of the clinical trial and registry are achieved. • Trained and mentored project coordinators, clinical research associates, and senior staff for clinical trial and registry activities within the DCRI Outcomes group. • Key contributor to protocol development, revisions, and amendments. • Responsible for reviewing/approving IRB submissions and monitoring of coordinating center clinical trial and registry approvals and renewals. • Experienced in overseeing the overall management of the clinical trial and registry from start-up to closeout in addition to identifying operational problems and provide recommendations and methods for implementation for study improvement. • Responsible for developing and implementing strategies for data monitoring to ensure high data quality of all study sites. • Effectively developed study processes and work practices for both the DCRI Outcomes Group and study start-up. • Highly knowledgeable in all facets of clinical research including start-up, trial design, data management, study close-out and all regulatory and FDA requirements. • Supervised/managed assigned operations team of clinical trial assistants and clinical trial coordinators. Responsible for conducting annual PEP evaluations; evaluate the training needs of staff in accordance with the departmental standards.