Responsibilities 60% - Program Operations * Serve as the Lead CRA for the Children s Oncology Group (COG) Program. Provide direction and guidance to local and affiliate researchers and staff regarding COG membership and research activities. * On and off-site oversight of COG research activities at the Duluth Clinic and other outreach clinics * Be an effective Divisional representative in assigned working groups within the Department of Pediatrics, Masonic Cancer Center and Medical School * Understand the U of M and other regulatory processes to ensure trials are available for subject enrollment. * Attend 1-2 national Children s Oncology Group meetings per year * Work with Division leadership to identify areas for process improvement and develop new SOPs as needed * Serve as liaison with other UMP/Fairview departments and clinic settings to facilitate collaboration and resolution of operational issues related to managing research subjects and meeting research requirements. * Collaborate with Division administration to continue to enhance the development and growth of the research program
40% - Administration/Management * Accomplish Department objectives by supervising staff, organizing and monitoring work processes * Mentor and train new and existing CRA staff for continued growth (CRA responsibilities include: entering data into an EDC, preparing/shipping lab samples, deviation reporting, adherence to protocol/ SOPs/GCP, source document review and problem identification, working collaboratively with monitors/scheduling/monitoring visits, consenting/re-consenting subjects as applicable per protocol and patient status, and any additional tasks as required) * Assist with the measurement and development of staff clinical and research competencies, this includes identifying and coordinating ongoing training needs * Facilitate collaborative, problem solving and team building with staff to ensure optimal resource utilization and efficiency of day-to-day clinical trial operations * Participate in the promotion and support of an environment that is conducive to staff growth and development * Assist with ensuring staff adherence to university, state and federal policies and procedures * Address and manage conflict in the workplace * Manage CRA workload (this includes, but is not limited to): assign new studies to staff, temporarily reassign staff to existing studies for overloaded; identify staffing deficiencies and reassign CRAs as needed) * Monitor and evaluate staff performance, this includes monitoring trial performance and ability to meet roles and responsibilities expectations and timelines * Identify performance issues and develop a plan for re-education to ensure overall quality of work * Collaborate on interviewing, hiring, orienting and onboarding new employees * Assist with the management and monitoring of planned and unplanned staff time off to ensure adequate staffing
***All required qualifications must be documented on application materials***
Required Qualifications * BA/BS with at least five years of experience or an advanced degree with three years of experience, or a combination of related education and work experience to equal nine years * Experience with computerized data management in a healthcare setting, including electronic medical records * Demonstrated ability to identify data for abstraction * Computer proficiency in a PC environment including Microsoft Office products such as Word, Excel, PowerPoint and Access * Detail-oriented with exceptional organizational, planning and problem-solving skills * Demonstrated ability to maintain deadlines and prioritize assignments * Ability to effectively work with investigators of all experience levels * Ability to lead and execute independent initiatives * Strong analytical skills * Excellent written, verbal and interpersonal skills * Expert knowledge of Good Clinical Practices (GCPs), and federal regulations related to clinical research * Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) certification or equivalent or ability to obtain certification within 6 months of hire
Preferred Qualifications * Master's degree in a science or health related field * Experience working in an academic medical setting * Experience in an oncology, BMT, pediatric, or other acute medical setting * Experience with pediatric drug trials * Ability to be an independent and collaborative leader * Experience directly supervising and/or mentoring and training staff and students * Experience with IND regulations and research strongly preferred
Internal Number: 333718
About University of Minnesota, Twin Cities
The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.