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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.

Job Summary

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, Michigan Medicine 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 (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 email, 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). Prefer experience as a Clinical Research Study Coordinator and membership in at least 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 OnCore,JIRA, eRRM, and eRPM. Knowledge of NCD and LCD is also preferred.

Mission Statement

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.

Why Join Michigan Medicine?

Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world’s most distinguished academic health systems.  In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.

What Benefits can you Look Forward to?

  • Excellent medical, dental and vision coverage effective on your very first day
  • Retirement Savings Opportunities

Responsibilities*

  • Acting 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 Clinical Trial Management System (OnCore.) Consistently use tact, diplomacy, and persuasion and excellent customer service in all interactions including those with Study Teams, Leadership, vendor, coworkers, and colleagues.
  • Perform 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 intermediate 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, Michigan Medicine 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 CRB software systems.
  • 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 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.

Required Qualifications*

  • Bachelor’s Degree minimum (prefer Masters).
  • 3-5 years of related experience of which two years should be of prior research compliance oversight and/or research experience
  • 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 OnCore, JIRA, eRRM, and eRPM.

Desired Qualifications*

  • Prefer experience as a Clinical Research Study Coordinator and membership in at least one of the following professional Certifications; ACRP, CCRP, and/or SOCRA.
  • Knowledge of NCD and LCD is preferred.
  • Experience with biomedical research is preferred

Background Screening

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. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.

Application Deadline

Job openings are posted for a minimum of seven calendar days.  The review and selection process may begin as early as the eighth day after posting. This opening 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.