Sr. Manager, Research Support

Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet. The Sylvester Comprehensive Cancer Center has an exciting opportunity for a Full-Time Senior Manager, Research Support. The Sr. Manager, Research Support leads the research program teams to ensure successful system implementation and upgrades. Specifically, the Sr. Manager, Research Support oversees the day-to-day operations and resources of research staff and supports programs for their growth and development. Manage multiple CRS clinical research staff, including clinical research coordinators and data coordinators, assigned to the Site Disease Groups (SDGs). Individual will be responsible for clinical research team recruitment, screening, interviewing, hiring, performance evaluations, counseling, etc. Perform and manage the assignment of workload to clinical research staff. Ensure all clinical research duties/tasks performed by clinical research staff are implemented/performed as per the requirements of the protocol, sponsor requirements and guidelines, the federal regulations and Good Clinical Practice guidelines and UM policies and procedures. 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, federal regulations, Good Clinical Practice guidelines and UM policies and procedures. Work with the CRS managers and leadership on the development and maintenance of 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 affiliate networks. Perform or facilitate all CRS clinical research staff training. Assess and monitor the implementation of the training and identify noncompliance. Perform follow-up training as required. Build relationships with investigators and provide investigator training on new CRS processes. In concert with the SDG chairs, create and maintain a complete clinical trial menu for each site disease group. Review new studies and assist in the creation of the clinical protocol design, the protocol’s development and its preparation for implementation. Working with Quality Assurance staff, ensure all required systems and processes are in place prior to a new protocol’s implementation. In cooperation with the Executive Director for Compliance, respond to any variance and implement corrective actions. Manage all audits and audit responses. Manage all communication with the sponsor and outside agencies as required. Complete annual performance reviews of all direct reports following UM HR procedures. Evaluate staff performance regularly during the rest of the year and communicate these assessments to staff members in a constructive way. This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary. MINIMUM QUALIFICATIONS Bachelor’s degree in relevant field required. Master's degree preferred Minimum 5 years of relevant experience required. 3 years with direct oversight of clinical trial operations. Experience conducting quality assurance reviews and data analysis preferred. Must obtain one of the following certifications during the first year of employment: 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. Excellent English skills (both verbal and written) required. The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more. UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. 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 sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for. Patient safety is a top priority. As a result, during the Influenza ("the flu") season (September through April), the University Of Miami Miller School Of Medicine requires all employees who provide ongoing services to patients, work in a location (all Hospitals and clinics) where patient care is provided, or work in patient care or clinical care areas, to have an annual influenza vaccination. Failure to meet this requirement will result in rescinding or termination of employment. The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information. Job Status: Full time Employee Type: Staff Pay Grade: r8 The mission of the University of Miami is to transform lives through education, research, innovation, and service. A vibrant and diverse academic and healthcare community, the University of Miami and the University of Miami Health System ("UHealth") have rapidly progressed to become one of the nation’s top research universities and academic medical centers in the nation. The University comprises 12 schools and colleges serving undergraduate and graduate students in more than 350 majors and programs. Visit welcome.miami.edu/about-um to learn more about our points of pride. The University ranks No. 55 on U.S. News & World Report’s 2022 Best Colleges list and ranked No. 49 in the 2022 Wall Street Journal/Times Higher Education College Rankings. Bascom Palmer Eye Institute is ranked the #1 eye hospital in the USA and offers some of the nation's premiere eye doctors to treat every eye condition for adults. Sylvester Comprehensive Cancer, part of the Miller School of Medicine, received the prestigious National Cancer Institute designation in 2019. The University of Miami and UHealth have also ranked among the Forbes Best Employers and Best Employers for Women on several occasions, most recently in 2022. Transforming lives With more than 17,000 faculty and staff, the University strives for excellence, and is driven by a powerful mission to transform and impact the lives of its students, patients, members of the community, and people across the globe. The University is committed to fostering a culture of belonging, where everyone feels valued and has the opportunity to add value. Through values of Diversity, Integrity, Responsibility, Excellence, Compassion, Creativity, and Teamwork (DIRECCT) the U community works together to create an environment driven by purpose, excellence, community, and service.

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