The University of Miami Miller School of Medicine-UHealth is home to some of the brightest minds in the world. Our Faculty teach students who represent the future of medicine. Our researchers are discovering breakthrough patient treatments. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and subspecialties, and have more than one million patient encounters each year.
The University of Miami, Miller School of Medicine, Department of Sylvester Comprehensive Cancer Center is seeking a Senior Manager, Research Support who will be responsible for day to day management of Clinical Research Services (CRS) clinical research staff who are assigned to multiple site disease groups (SDGs). Management would include the oversight of over 125 clinical research protocols, which have resulted in the accrual of over 250 patients in the last year. Subsequently, the CRS clinical research manager will manage approximately 700 ongoing clinical research patients. The CRS clinical research manager would manage the day to day interactions and subsequent services CRS clinical research staff provides to the sixteen SCCC specific Site Disease Group’s (SDG’s). Manage multiple CRS clinical research staff assigned to a Site Disease Group (SDG). Individual will be responsible for clinical research team recruitment, screening, interviewing, hiring performance evaluations, counseling, etc. Manage the initiation of continuing educational programs for CRS clinical research staff, including the facilitation of the clinical research staff licensing, certifications, training, Continuing Education Units (CEUs) through the use of in-services, guest lectures, workshops and other in-house seminars. Ensure clinical research staff participate in outside educational conferences and workshops as warranted. Perform all necessary clinical research staff training to ensure compliance with the protocol, CRS Standard Operating Procedures (SOPs), sponsor requirements, the federal regulations, Good Clinical Practice guidelines and UM policies and procedures. Work with the Regulatory Manager and Financial Manager in the development and maintenance of the CRS SOPs. Create clinical research staff orientation manuals, implement necessary systems, processes and procedures for the support of clinical trials research. This includes overseeing the creation and maintenance of policies and procedures as they relate to regulatory affairs, quality assurance, financial affairs, and all affiliate networks. Performs all CRS clinical research staff training. Ensures the implementation of training is implemented into daily research procedures. Assess and monitor the implementation of the training and identify noncompliance.
Bachelor’s degree required, preferably in Nursing or other healthcare relate field, Master’s preferred. Four years work related experience is required, including supervisory experience, and three years experience in the site management of clinical trials. Experience conducting quality assurance reviews and data analysis preferred. Current holder of one of the following certifications is highly preferred: Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Associate (CCRA), Certified Clinical Research Professional (CCRP), and/or Oncology Research Nurse Certification. Must have excellent knowledge of the Code of Federal Regulations and Good Clinical Practice. Must have excellent skills in general computer applications (e.g., word, Outlook, Excel, Adobe, various electronic data capture (EDC) systems). Must have the ability to be trained in specialized database and statistical programs. Must complete CITI Certification training once employed. Excellent English skills (both verbal and written) required. Any appropriate combination of relevant education, experience and/or certifications will be considered.
UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the groundbreaking research and medical education at the Miller School of Medicine. University of Miami Hospital is the flagship facility of UHealth, which also includes the Sylvester Comprehensive Cancer Center and Bascom Palmer Eye Institute, along with dozens of outpatient facilities. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.