Research Support - Laboratory/Non-Laboratory, Staff/Administrative
Position Summary: The main purpose of this position is to supervise and develop Pediatric Hematology/Oncology clinical research staff and to oversee the daily clinical research activities of the Division. This position will also work collaboratively with leadership to facilitate growth of our research programs. This position will serve as Lead CRA for our Children’s Oncology Group program, under which we conduct Phase 1, 2 and 3 research. This position reports to the Pediatric Hematology/Oncology Division Administrator, but is accountable to the physician-investigators and the research team.
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)
Measure and develop staff clinical and research competencies, including 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
Ensure 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
Manage and monitor planned and unplanned staff time off to ensure adequate staff and coverage plans for efficient and effective clinical trial operations.
Disseminate information from leadership to entire team
Help CRAs manage deadlines and develop plan of action to meet job expectations
As needed, provide relief support to other CRA members of the research team. This includes:
Confirm eligibility of potential subjects and oversee study enrollments.
Ensure required observations are performed and research specimens are collected per protocol requirements.
Monitoring, coding, and reporting of toxicities and adverse events experienced by research subjects.
BA/BS with at least six years of experience or an advanced degree with four years of experience
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
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: 337541
About University of Minnesota, Twin Cities
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