Senior Clinical Research Professional, Department of Emergency Medicine Current UC employees must apply internally via SuccessFactors > http://bit.ly/UCEMPL Founded in 1819, the University of Cincinnati ranks among the nation's best urban public research universities. Home to more than 50,000 students, 11,000 faculty and staff and 340,000 alumni, UC combines a Top 35 public research university with a physical setting The New York Times calls "the most ambitious campus design program in the country." With the launch of Next Lives Here, the Cincinnati Innovation District, a $100 million JobsOhio investment, nine straight years of record enrollment, worldwide leadership in cooperative education, a dynamic academic health center and entry into the Big 12 Conference, UC's momentum has never been stronger. UC's annual budget tops $1.65 billion and its endowment totals $1.8 billion. The University's overall regional economic impact exceeds $10.6 billion, paving the way for the future of Cincinnati. Job Overview As one of the oldest medical schools in the country, the UC College of Medicine has a reputation for training best-in-class health care professionals and developing cutting-edge procedures and research that improves the health and clinical care of patients. The UC Department of Emergency Medicine at the University of Cincinnati has been an independent academic unit within the College of Medicine since 1984. It is responsible for the medical direction of the University of Cincinnati Medical Center, Center for Emergency Care (CEC) and the Emergency Medicine Residency Training Program. The Department of Emergency Medicine is seeking a Senior Clinical Research Professional who will serve as the research division's regulatory coordinator in charge of regulatory submissions to the IRB and FDA, sponsor interface, document management and research compliance. This team member will work with the clinical research professionals team that coordinates research studies in an acute care setting. Essential Functions Act as a liaison with medical staff, university departments, ancillary departments and/or satellite facilities. Serve as a peer-mentor within the department, supporting management and in various responsibilities as appropriate including the development of less experienced team members. Contribute to the development of new processes, procedures, tools and training to enhance clinical research activities, compliance, and efficiency. Ensure compliance with contract principles, federal regulations, laws and University of Cincinnati/University of Cincinnati Physicians Company (UCPC) policy and operating procedures. Prepare, submit, and assist Director with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms). Prepare and maintain FDA applications for lnvestigational New Drugs (INDs). Maintain regulatory documentation. Make and assist in modifying protocols and study documents. Write reports, business correspondence, and procedure manuals. Consent writing and eConsent creation. Conduct adverse event reporting. Manage office documents including training certificates, CVs, and licenses. Maintain clinicaltrials.gov listings. Act as liaison between study personnel and data entry specialists. Perform related duties based on departmental need. This job description can be changed at any time. Required Education Bachelor's Degree in Biology, Health Sciences, or a related field. Seven (7) years of relevant work experience and/or other specialized training can be used in lieu of education requirement. Additional Qualifications Considered Master's degree. Experience working in an academic research setting. Experience with Redcap or eRegulatory. Clinical Research Professional Certifica