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Research Compliance Spec Assoc

Company: Medical School
Location: Ann Arbor
Posted on: February 16, 2020

Job Description:

The Michigan Alzheimer's Disease Center (MADC) is seeking a full time MADC Regulatory Specialist to join its research team. This person will assist the MADC Administrators with all administrative duties related to the Center's research activities. Location is at the University of Michigan Alzheimer Disease Center (MADC), 2101 Commonwealth Blvd, Suite D, Ann Arbor, where there is free staff parking. This is a 40 hour/week position, Monday-Friday, 8 - 5 pm.
A cover letter is required for consideration of 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. It should also include your current or ending salary.
Please label your job application file as follows: last name, first name, job posting ID#.

Job Summary
We are seeking an experienced, positive, highly motivated, organized, autonomous person with excellent multi-tasking ability and record-keeping skills to assist the MADC administrators and research team to accurately and efficiently carry out a range of tasks. The research team includes neurologists, neuropsychologists, administrators, program managers, study coordinators, and data analysts. The characteristic duties and responsibilities of this position may evolve over time to match changing needs and priorities.

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
  • 2:1 Match on retirement savings.

    Responsibilities*
    • Assist the MADC Research Administrator and research team in managing, reviewing, completing and submitting Institutional Review Board (IRB) applications for all affiliated MADC projects.
    • Assist in developing internal and external regulatory/compliance documents related to IRB submissions for new and current projects
    • Review study protocols; create new and/or amend IRB applications as needed. Set up IRB applications, billing calendars, and other recruitment documents required as part of IRB submissions. Correspond with IRB and other regulatory units as needed
    • Create and review informed consent forms and other recruitment and regulatory documents for all MADC affiliated projects
    • Assist with MADC IRB Ancillary Committee Review process. Schedule and assist with MADC Research Initialization Study Meetings
    • Assist with study start-up and development of local research procedures and processes for NIH and industry- sponsored clinical research projects
    • Manage the annual MADC Pilot Project application and award process
    • Other duties as assigned


      Required Qualifications*
      • Bachelor's degree in a health related field or equivalent education and experience
        • Computer proficiency (i.e. Microsoft Word, Excel, Power Point)
        • 1-2 years of experience with regulatory documentation or training
        • A working knowledge of IRB processes, Good Clinical Practice and HIPAA
        • Confident and highly motivated with excellent multi-tasking ability and record-keeping skills
        • Excellent attention to detail
        • Professional demeanor and excellent interpersonal and communication skills
        • Proven ability to work independently with minimal supervision
        • Ability to work with diverse teams of people in a diplomatic, collaborative and effective manner
        • Ability to problem-solve and establish timelines and priorities


          Desired Qualifications*
          • Experience working in a research setting
          • Research experience with investigator-initiated and federal sponsored trials
          • A working knowledge of FDA guidance
            • Familiarity with EndNote
            • Experience using eResearch regulatory platform/OnCore/EPIC
            • A working knowledge of medical terminology
            • PEERRS or equivalent certified
              • Reasonable knowledge of university policies and procedures


                Additional Information
                Diversity is highly valued and applications from members of groups underrepresented in health sciences with demonstrated ability to work effectively with individuals from diverse communities, cultures and the elder population are encouraged to apply.

                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.

                U-M EEO/AA Statement
                The University of Michigan is an equal opportunity/affirmative action employer.

Keywords: Medical School, Ann Arbor , Research Compliance Spec Assoc, Other , Ann Arbor, Michigan

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