Research Project ManagementWork under the guidance of the Associate Director and principal investigators to meet research study objectives. Provide day-to-day project management and coordination for multiple studies, which may vary in scope and clinical area. Manage the research team to ensure that all study activities are completed according to applicable regulations and guidelines and adhere to the protocol and Good Clinical Practice. Develop and oversee execution of recruitment strategies to ensure recruitment goals are met. Develop, organize, and maintain study databases and ensure data is complete and accurate. Help to facilitate project collaborations and teamwork. Maintain broad organizational perspective to effectively carry out internal and external relationships of the program. Coordinate and collect Texas Biologics pilot research project biospecimen samples. Oversee the collection and maintenance of appropriate source documentation and ensure accurate entry into study specific databases. Manage, document, and report on adverse events, compliance, and other participant related safety issues. Collaborate with investigators to ensure proper conduct of all aspects of clinical research. Implement and recommend policies and procedures to ensure compliance of all applicable laws, University policies, rules and regulations. Develop instructional materials to aid new physician investigators with study development and start-up requirements. Oversee the creation and maintenance of research protocols on the clinicaltrials.gov website. Assist with development of QI projects for hospital medicine. Screen, recruit, and enroll eligible patients and track participation over time. Conduct and manage study visits and participant assessments/interviews, which may include collection of biological specimens. Act as primary contact for study participants. Participate in data collection, data entry, and data organization. Manage the consent of participants and completing study visits with participants. Perform Quality Assurance/Quality Control of study data.Research team supportRecruit and manage research staff and learners across all research projects (research assistants/ research coordinators). Supervise the career development and training of research staff. Assist with manuscript preparation and editing. Maintain working relationships with other study teams internal and external to UT. Support the development and submission of grant proposals, publications, presentations, reports, and other study-related documents. Enter data and perform literature searches, administrative duties, and additional tasks as needed. Prepare presentations and help draft and submit manuscripts. Assist with developing grant proposals, including submission and reporting processes. Draft and facilitate institutional review board (IRB) applications, submissions, and updates. Assist in preparing study progress reports. Actively participate in research department meetings and events. Liaise with the Office of Research (OOR) as necessary; advocate for and use updated research resources posted on the intranet. Support other pilot projects as prioritized and time allows.Regulatory ManagementDesign Regulatory binders for the studies and oversee maintenance for the duration of the study. Manage the distribution of methods and instruments, conducting surveys, chart abstraction, maintaining regulatory compliance, collecting biospecimens, performing laboratory processes. Identify staff, patient, and system issues that impact participants and implement resolutions to better serve study participants. Participate in and facilitate study team meetings as well as trainings for the study team. Create, review and submit NDAs, MTAs, DUAs and other contracts on behalf of the PI, which may include but not limited to: formatting, documentation, reporting, project summaries/reports/analysis, review of expenditures, submissions, etc. Assist PIs Protocol Submission and Regulatory Comp iance, including but not limited to: assisting PIs with IRB, IBC and Biosafety protocols, maintain EHS records for required personnel training, procedures, and reposting, submitting minor changes and annual reporting to institutional committees. Present at Research Nuts and Bolts on specific topic assigned. Provide lectures or other education to study coordinator and research support staff. Assist with special projects and any other tasks as related business needs arise. Oversee and assist in the management and development of faculty research budgets. Manage effort allocation of staff and insure accurate reporting and timely corrections.Other related duties as assigned.