Job Information
University of Cincinnati Clinical Research Project Manager, Department of Neurology & Rehabilitation Medi in Cincinnati, Ohio
Clinical Research Project Manager, Department of Neurology & Rehabilitation Medicine, Stroke Current UC employees must apply internally via SuccessFactors > 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 the Trial Project Manager of this NIH/NINDS-funded study, SISTER (Treatment with Endovascular Intervention for Stroke Patients with Existing Disability), the candidate will facilitate the coordination of a national, multicenter, randomized clinical study to evaluate the efficacy and safety of a novel clot dissolving medication within NIH StrokeNet. Approximately 40 US sites will enroll 300 participants. This unique study aims to bring forward a breakthrough acute stroke treatment. This treatment has the potential to drastically expand the number of stroke patients that are able to receive a life and disability saving acute stroke treatments. The appropriate candidate will have extensive clinical trial study coordination experience. Experience with clinical trials involving drug and the FDA is a plus. Salary is commensurate with the role. Essential Functions This person will work closely with national PIs on clinical and data coordination and share responsibilities for management of the performance sites. This person will assist the study PIs at the University of Cincinnati in broad oversight of all administrative aspects of the trial such as communication with the NIH StrokeNet's single Institutional Review Board, the National Coordinating Center, and the National Data Management Center. Specific jobs, in partnership with the StrokeNet National Coordinating Center Project Manager, will include coordination of site startup activities, providing regulatory assistance to the sites for single IRB process; developing and delivering site protocol training for study specific procedures; helping with central pharmacy with planning of drug shipping and stocking; scheduling and leading site readiness calls; helping to plan national investigator and coordinator meetings; coordinating meetings with the scientific advisory board; contributing to the ongoing monitoring of recruitment and retention; posting trial development on clinical trials.gov; and assisting with other ongoing communication with sites, including newsletters and webinars, and NIH about all aspects of study as requested. This person will also share responsibility for creation and maintenance of the trial manual of procedures, and safety monitoring tasks. Required Education Bachelor's Degree Nine (9) years of relevant work experience and/or other specialized training can be used in lieu of education requirement. Required Experience Five (5) years related experience. Additional Qualifications Considered Experience in an academic or clinical setting in the area of clinical specialization. SoCRA or ACRP certification. Physical Requirements/Work Environment Sitting - Continuously Compensation and Benefits UC offers a wide array of complementary and affordable benefit options, to meet the fina