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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 Associate will act as a resource to Study teams including Study Coordinators, Clinical Trials Support Units (CTSU's), 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 (CTMS). Consistently use tact, diplomacy, and persuasion and excellent customer service in all interactions including those with Study Teams, Leadership, vendor, coworkers, and colleagues.
Utilize Excel, OnCore and MBECT in building, editing and uploading clinical research billing calendars that align with a studies core documents (i.e Protocol, Informed Consent, Budget and contract). Learn how to perform a 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.
The Research Compliance Specialist Associate is also 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.
Assist in developing, administering, formulating and defining scope and objectives of clinical research billing process while modifying moderately complex information systems.
As needed this person will act as desk top support, monitor help email, and will provide training for CRAO systems.
The incumbent will at times assist in coordinating 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 create and distribute accordingly meeting agendas and minutes.
Work to strengthen and appropriately expand the processes of the CRAO as required by emerging regulatory and institutional needs.
Bachelor's Degree minimum or 3-5 Years related experience in Clinical Research or Compliance. Prefer experience as a Clinical Research Study Coordinator and membership in one of the following professional Certifications; ACRP, CCRP, and/or SOCRA. 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 and prefer experience in MBECT,JIRA, eRRM, and eRPM. Knowledge of NCD and LCD is also preferred.
Between the hours of 7am-5pm
North Campus, Ann Arbor
University of Michigan Health System 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.
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.