Clinical Research Manager - UNIVERSITY OF TEXAS AT AUSTIN

Research ManagementWork under the guidance of the Assistant Director of Research and principal investigators to meet research study objectives. Oversee day-to-day clinical trials management and coordination for multiple studies, which may vary in scope and clinical area.? Manage the clinical trial 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. Manage project collaborations and teamwork. Maintain broad organizational perspective to effectively carry out internal and external relationships of the program. ? 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.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 clinical trials protocols and budgets and other study-related documents.? Enter data and perform literature searches, administrative duties, and additional tasks as needed. 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.Regulatory ManagementIdentify 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. Assist with PIs Protocol Submission and Regulatory Compliance, including but not limited to: assisting PIs with IRB, IBC and Biosafety protocols, maintain drug storage records, study, records and EHS records for required personnel training, procedures, and reposting, submitting minor changes and annual reporting to institutional committees. Assist with special projects and any other tasks as related business needs arise.Financial/Operational ManagementOversee and assist in the management and development of faculty research budgets. Manage effort allocation of staff and ensure accurate reporting and timely corrections. Track and report clinical trials financials to department leadership. Find opportunities to make clinical trials financially viable. Work with Assistant Director of Research on all research initiatives, operations and administrative support including philanthropic, psychedelic and research team support.Other related duties as assigned.