The Study Initiation Specialist is responsible for the review and interpretation of research protocols to determine the need for Epic Orders, Research Smart Set, or Treatment Plan. The Specialist will draft the appropriate template(s) (e.g. Research Orders Set, Smart Set or Treatment Plan) that include Epic order codes and review the draft with the PI, study team and Clinical Trials Financial Services (CTFS) to ensure complete and accurate information. Once the information in the template is accurate, complete, reconciled with the CTFS calendar and signed off by the PI, the Specialist provides the template to the appropriate Fairview Epic expert (for Research Orders Set, Treatment Plan, or Smart Set) for submission for build in EHR. The Study Initiation Specialist will also serve as a clinical resource to the OnCore team and the CTFS team when protocol interpretation, Epic order code identification, and/or pricing questions require clinical expertise.
Review new studies using clinical services (University of Minnesota Medical Center, Clinics and Surgery Center, UMPhysicians, Fairview Heath Services, etc.) Assess studies for Epic Order or Treatment Plan needs, including:
Collaborate with CTFS in the review study documents to understand research-specific clinical activities, initial billing designations, including qualifying trial status, and draft of the billing grid; identify appropriate Epic order codes
Draft research order template, which is used as the basis of the Epic order, and which should reconcile with visit calendar
Meet and communicate with study teams to clarify and validate these assessments
Collaborate with Fairview Research Administration/UMP pricing teams, investigational pharmacies, and the Epic build team to reconcile all components
Track and facilitate the build process until the requirements for approval have been met
Work in collaboration with the OnCore project team and CTFS to refine workflows to support entry of Research Orders in EPIC
Help with oversight of build assignment and metrics for research order sets and research treatment plans. Maintain a database for tracking built research orders and be responsible for the order build queue.
Review amendment and correction requests received through order build queue and study startup process and coordinate with Clinical Trials Financial Services, Fairview Research Administration, UMP pricing, the CTSI Epic build team to make the appropriate changes in OnCore and Epic (if applicable).
Field questions from the research community about study initiation, including the subject worksheet/calendar template and Epic Orders.
Support clinical research community use of Epic for research orders and serve on committees dealing with research-related issues, as assigned.
Serve as a liaison with the Fairview Research Administration/UMP pricing teams and Epic build teams, identifying best practices and advising AHC finance on complex research billing issues.
Participate in the Ambulatory Clinical Decision Support Committee and the Inpatient Clinical Decision Support Committee.
All required qualifications must be documented on application materials
Graduation from an accredited bachelor's degree program in a clinical field such as a Registered Nurse (RN), Physician’s Assistant (PA) or Pharmacist with a minimum of 4 years of experience with 2 years being healthcare experience; or one of the following:
Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) or associates degree in clinical trials research related curriculum plus a minimum of six years clinical and/or research experience; or
Completion of a bachelor’s degree in a field related to health science and a minimum of 4 years clinical and/or research experience; or
An advanced degree in a field related to health science and a minimum of 2 years of experience; or
A combination of related education and work experience to equal eight years.
Experience using Epic or other electronic health record
Demonstrated/documented understanding of both clinical workflows and clinical research workflows
Demonstrated/documented excellent oral and written communication skills
Documented experience managing multiple projects at one time
Demonstrated/documented interpersonal and collaborative workstyle
Experience facilitating group/team meetings
Experience using OnCore clinical trial management system
Experience in an academic health center
Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP)
Internal Number: 319139
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.