Heather M. Email & Phone Number

Chicago, Il, Us

•Manages regulatory functions for cancer clinical trials from start to finish (e.g. initial IRB and amendment submissions, annual renewal submissions, startup documents, etc.).•Monitors applicable regulatory requirements; assures compliance with internal and external standards.•Collects information and manages deadlines for annual renewal submission. Maintains organization of the binders associated with each trial. •Develops and documents sound regulatory decisions and… Show more •Manages regulatory functions for cancer clinical trials from start to finish (e.g. initial IRB and amendment submissions, annual renewal submissions, startup documents, etc.).•Monitors applicable regulatory requirements; assures compliance with internal and external standards.•Collects information and manages deadlines for annual renewal submission. Maintains organization of the binders associated with each trial. •Develops and documents sound regulatory decisions and justifications maintaining key quality regulatory compliance performance.•Maintains key regulatory documents: 1572, DOA logs, FDFs and training logs while continuously improving the regulatory maintenance process. •Serves as lead administrator for UC participation in cooperative group studies, handles rosters, affiliates and submissions to the NCI Central IRB•Manages submissions of Investigational New Drug Applications and oversees amendments and annual reports to the FDA•Acts as liaison with external auditors during third party/regulatory audits as well as between local IRB and external sponsors, CROs, cooperative groups.•Responsible for the distribution and tracking of external safety reports to the Principal Investigator for review and submission to the IRB•Actively participates in continuous improvement efforts and activities. Show less

•Responsible for the data and safety monitoring program for over 650 clinical trials to ensure compliance with requirements regarding the reporting of adverse events and plans for assuring data accuracy and protocol compliance•Planned and coordinated monthly audits to review the conduct of clinical trials to ensure the study is in compliance with the currently approved protocol/amendments, Good Clinical Practice, and other regulatory requirements•Worked with Research Nurses and Research… Show more •Responsible for the data and safety monitoring program for over 650 clinical trials to ensure compliance with requirements regarding the reporting of adverse events and plans for assuring data accuracy and protocol compliance•Planned and coordinated monthly audits to review the conduct of clinical trials to ensure the study is in compliance with the currently approved protocol/amendments, Good Clinical Practice, and other regulatory requirements•Worked with Research Nurses and Research Professionals in reporting adverse drug reactions and submitting accurate and appropriate reports within the time period designated by the FDA, IRB, and study sponsors •Oversight of clerical staff in the implementation of the quality management and audit system•Develop and maintain a Quality Assurance Manual that documents procedures and may be used in the training and orientation of new staff Show less

•Participated in the conduct of clinical research by assisting with fulfillment of regulatory and administrative functions of clinical trials•Served as a liaison between principal investigators, regulatory agencies, and other members of research teams•Worked collectively with the Regulatory Managers in completing and processing regulatory documents for review to the IRB, Clinical Trials Review Committee, and external sponsors. •Worked with the Quality Assurance Operations Manager… Show more •Participated in the conduct of clinical research by assisting with fulfillment of regulatory and administrative functions of clinical trials•Served as a liaison between principal investigators, regulatory agencies, and other members of research teams•Worked collectively with the Regulatory Managers in completing and processing regulatory documents for review to the IRB, Clinical Trials Review Committee, and external sponsors. •Worked with the Quality Assurance Operations Manager in management of adverse event reporting and entering of data safety monitoring minutes into Velos •Organized and managed NCI registration for Investigators and fellows and maintain status records of annual expiration dates•Responsible for smooth and efficient operation and management of daily activities in the office•Interviewed and oversee part time students to coordinate their work assignments Show less

Certificate, Clinical Trials Management & Regulatory Compliance

This Certificate program provides comprehensive training across the entire clinical trials process from the perspective of the clinical.

Bachelor'S Degree, Audiology/Audiologist And Speech-Language Pathology/Pathologist