Devon Newman Email & Phone Number

Office of Research/Data Office for Clinical & Translational ResearchThe Data Office was developed to provide researchers access to genomic and clinical health data in a compliant and secure manner for the purposes of research. Currently functioning as the team lead to manage the teams work queue and budgeting goals.•Utilize software system to manage work queue to prioritize, assign, and track worklogs among team members•Manage the team and provide oversight and coordination within the Data Office•Responsible for the timeline and completion of team projects while serving as the point of contact among different study teams•Assist study team with reviewing study documents, protocols and recruitment methods•Develop new processes to support auditing procedures for Data Office•Perform HIPAA reviews for all contracts/agreements that involve data leaving the institution.•Manage monthly budgeting to process monthly invoicing•Create / maintain project cost estimates, required staff trainings, SOPs, best practice methods, project workflows and metrics•Promote and establish best practices for access to data, data sharing, and data storage plans for study teams•Identify, analyze, and suggest improvements to existing processes to streamline and improve the quality of our services to better match customer needs and to reduce administrative burden•Perform regulatory/compliance reviews for all projects that utilize the services within our office•Educate researchers and departments about our services by providing consultation and presentations•Facilitate cross functional team meetings, create agenda/minutes, and track action items•Provide insight/direction to researchers utilizing Data Office services and act as the liaison between IRB and Compliance•Collaborate with Office of Compliance, Office of Research & Sponsored Projects, and IRB to develop standards for access to clinical data and use of contracts/agreements

Michigan Institute for Clinical & Health Research (MICHR) / Registries & Cohorts ProgramThe Registries & Cohorts Program (RCP) was developed in 2011 to support research registries built for clinical research within Michigan Medicine. Functioned as the team lead for the program which offered consultation and guidance to help Michigan Medicine researchers with building large data registries and repositories. This program served as a building block for the current Data Office. •Developed operational strategies to streamline communication among stakeholders to reduce burden and ensure regulatory compliance for each project•Oversee the administrative and operational activities to provide overall management of the Registry Program •Created and maintained project metrics, timelines, and project plans for the program•Planned and conducted educational workshops on with Michigan Medicine Education Unit to help educate researchers and study team members•Maintained the management reporting software program to help track the status of all ongoing projects•Collaborated with team members/leadership to define goals/deliverables, create best practices, and SOPs.

Program for Positive Aging/Geriatric Psychiatry Overall management of multiple grant-funded research studies at the University of Michigan and the Veterans Affairs Medical Center. Responsibilities included pre- and post-award support, clinical data acquisition, data quality assurance, SAE and AE reporting, management and monitoring of clinical study team and activities to ensure regulatory compliance. Submission of annual reports on study activities for regulatory and funder review. •Managed the day-to-day operations of the study team, IRB documents and audits, study surveys, study recruitment and timelines, budgets, grant preparation, data collection, publications, and other appropriate study procedures•Acted as a liaison for the Principle Investigator, the IRB, and other study team members•Provided new practices for the team which increased enrollment and retention in aging study participants for research studies that dealt with very delicate topics•Coordinated all subject recruitment, enrollment, and follow up activities with a successful 98% follow up rate and 28% refusal rate

Clinical Research Coordinator Responsible for the overall management / monitoring of assigned clinical trials including study scheduling, planning, and managing protocol resources of Phase I studies. Responsible for clinical data acquisition, data quality assurance, supporting and monitoring clinical study activities. •Coordinated clinical trials from study design, initiation, implementation to closeout and data evaluation.•Developed study activity documents and the necessary materials required for study conduct •Trained clinical research technicians in GCP, FDA regulations and Phase I study procedures•Reviewed and provided input on study documents such as protocols and informed consent documents•Provided basic subject medical care and diagnostic tests, technical training and sample tracking and management•Performed as a task force member for department needs to address productivity, cost reduction, process streamliningDatabase Administrator – Phase 1 Management System Responsible for the study specific database collection system for Phase 1 trials encompassing all aspects from study setup, volunteer recruitment, study data capture, and study completion activities. Developed initial database programming and data management activities for Phase 1 studies. Responsible for the interpretation and execution of scientific protocols and providing specific feedback to scientists to ensure that all required data is captured.•Created the database for study specific events to enable clean data capture and study day time tracking procedures to minimize protocol deviations•Collected and analyzed data for on-going clinical trials•Managed the data management / cleaning activities for assigned protocols•100% successful in supporting our team in meeting a global 24-hour challenge for database lock•Provided leadership on specialized projects and assist in the training of inexperienced staff

Medical Assistant Four years of experience working as a medical assistant while attending college as a full-time student and athlete. Two of those years, assisted doctors in a family care setting providing general care to patients of all ages. Demonstrated clinical expertise in phlebotomy, administering immunizations and injections, x-rays, and electrocardiograms. The following two years assisted doctors in an urgent care/occupational health care facility providing similar care and services for patients, in addition to assisting with minor surgical procedures. I also became certified to perform audiograms, drug screens, breath alcohol testing, and pulmonary function tests successfully.

Master Of Science - Ms, Project Management

Bachelor Of Science - Bs, Dietetics/Biology