Corinne Williams Email and Phone Number

Responsibilities are consistent with previous position. In addition, manage and train junior level project managers and development of standard project management training tools.Major Achievements: Created and implemented new innovative clinical trial analysis that improves project timeline projections, risk identification, and strategy development.

Manage National and Global clinical trials (phase I-III) from initiation to project closeout. Responsibilities include strategic planning, timeline oversight, budget and resource management, risk management, ensure FDA and GCP compliance, and facilitate effective communication among all project-related parties. In addition, develop, improve and implement standard project management tools, strategy, and methodology.Major Achievements: Created and implemented standard project management tools and processes including use of Microsoft Project.

In collaboration with principle investigators and research nurses, evaluate, initiate and maintain all activities related to the conduct of clinical trials in the Thoracic Oncology Program at IU Cancer center. Responsibilities include managing all regulatory documents, case report forms, and assessing and reporting all adverse events, serious adverse events, deviations, and other reportable events. Educate and train staff prior to implementation of new research trials. In addition, conduct on-site monitoring/auditing as needed. Overall, ensure that all research staff conduct research according to FDA regulations and Good Clinical Practice.

Function as project manager for clinical trials in the Colon and Rectal Surgery Department. Coordination and oversight of study participant activity as it relates to the conduct of research and clinical trials. Responsibilities include recruitment and enrollment of potential study participants, assist in trial development of study related budgets, manage regulatory documents and case report forms, assess and report all adverse events, serious adverse events, deviations, and other reportable events, and facilitate effective communication with external funding agencies and sponsors, other departments, departmental staff and study participants. Educate staff prior to implementation of new research trials. Overall, ensure that all research staff conducts research according to Good Clinical Practice.

Worked as a Research Assistant in the Department of Neuropsychology/ Behavioral and Preventative Medicine. Responsibilities included organization and collection of research data, subject recruitment. In addition, analyzed MRI brain scans, and administered and scored neuropsychological tests (e.g. memory, learning, motor skills and attention tests) for current studies.