How to Apply
A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.
The Research Compliance Specialist Intermediate is responsible for; Analyzing, comparing and evaluating varied courses of action to move CRAO and its customers towards Departmental goals as well as broader objectives set by The Office of Research, The Medical School and The University of Michigan.
Act as a resource to Study teams including Study Coordinators, PI's and other interested parties for questions/issues related to clinical research system issues including but not limited to our Michigan Budget Enrollment Calendar Tool (MBECT and OnCore Clinical Trials Management System). Consistently use tact, diplomacy, and persuasion and excellent customer service in all interactions including those with Study Teams, Leadership, vendor, coworkers, and colleagues.
These responsibilities include Performing Medicare Coverage Analysis for new clinical research studies as well as Amendments, in conjunction with review of all appropriate core documents which includes the clinical research billing calendar. Audit, correction and building of billing calendars as well as the application of appropriate coding information.
As needed develop and present educational materials to the research community to increase awareness of, and compliance with human subject regulations. Resolve questions about the application process and applicable regulations. Interpret regulations and develop internal guidance documents for use by review staff.
At times this person will act as desk top support, monitor help e-mail, and will provide training for Clinical Trials Management Systems (CTMS/OnCore). The incumbent will at times coordinate meetings, training schedules, develop evaluations of training classes and revise materials according to feedback and need. Participate in the creation of Standard Operating Procedures and training materials. Attend and Participate in team meetings and daily huddles as well as possibly create and distribute accordingly meeting agendas and minutes
Bachelor's Degree minimum (prefer Masters). 3-5 Years related experience in Clinical Research or Compliance.Exceptional communication skill set; written, oral presentation and listening. Excellent Attention to Details and stellar customer service a must. Under general direction is able to exercise considerable discretion and independent judgment. Proficiency in Microsoft Office Suite of products such as Excel, Visio and PowerPoint required.
Experience as a Clinical Research Study Coordinator and membership in at least one of the following professional Certifications; ACRP, CCRP, and/or SOCRA. Also prefer experience in MBECT,JIRA, eRRM, and eRPM. Knowledge of NCD and LCD is also preferred.
North Campus Resource Complex
Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act.
Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.
Job openings are posted for a minimum of seven calendar days. This job may be removed from posting boards and filled anytime after the minimum posting period has ended.
U-M EEO/AA Statement
The University of Michigan is an equal opportunity/affirmative action employer.