Amanda K. Coulter

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*Admitted in Michigan

Amanda regularly advises clients in the health care industry on clinical research matters. Amanda has extensive experience developing research compliance policies and processes, drafting and editing informed consent documents and HIPAA authorizations, and creating research-related policies and template agreements. Amanda assists clients by drafting, reviewing, and negotiating industry-sponsored clinical trial agreements, confidentiality agreements, data use agreements, material transfer agreements, investigator-initiated research agreements, research collaboration agreements, biological tissue supply agreements, professional physician services agreements, hospital services agreements, visiting scholar agreements, institutional review board reliance agreements, business associate agreements, and federal grants and subcontracts.

Before her work at Coppersmith Brockelman, Amanda was Associate Director of the Sponsored Projects office at the University of Michigan, where she trained and managed a team of contract negotiators and research administrators dedicated to clinical research contracts and grants. Amanda also developed, coordinated, and administered training to physicians, clinical research coordinators, and research administrators on research contracts, financial award management, grant administration, and research compliance. Amanda also worked for the University’s insurance company drafting and negotiating physician group agreements. Before joining the University of Michigan, Amanda was an associate attorney on the healthcare transactions and the medical malpractice defense litigation teams at a Michigan law firm.

Representative Matters

  • Represents healthcare providers in clinical research contracts.
  • Counsels research site management organizations regarding policies, procedures, and drafting and negotiating template agreements.
  • Counsels healthcare providers regarding research policies and clinical research agreement negotiation guides.
  • Counsels healthcare providers regarding clinical research compliance issues, including financial conflicts of interest, Institutional Review Board compliance and review, HIPAA, and Stark and Anti-Kickback compliance.

Publications & Speeches

  • Contributing author and editor, “Representing Hospitals: Chapter 28 Clinical Research,” American Health Law Association (publication date TBD)
  • Co-author, “Clinical Trial Agreements Toolkit,” American Health Law Association (May 2022)
  • Co-presenter, “Cyberliability and Finding the Balance on Data Security Practices,” MAGI Clinical Research vConference (October 2021)
  • Co-presenter, “Into the Abyss: Subject Injury and Indemnification,” MAGI Clinical Research vConference (May 2021)
  • Contributor, “Clinical Trial Agreements Evolving as Post Pandemic Era Gains Traction,” WCG CenterWatch (May 2021)
  • Co-presenter, “Dissecting a Clinical Trial Agreement: Part 2,” MAGI Clinical Research vConference (November 2020)
  • Co-presenter, “COVID-19’s Impact on Clinical Research,” American Health Law Association’s Speaking of Health Law podcast (July 2020)
  • Co-author (with K. Rosati), “How the COVID-19 Pandemic Immediately Impacts Clinical Trials: Considerations for Sites and Investigators,” AHLA Health Law Weekly (March 2020)
  • Co-presenter, “Creating and Using a CTA Negotiation Playbook,” MAGI Clinical Research Conference West (October 2019)
  • Co-presenter, “Dissecting a Clinical Trial Agreement: Part 2,” MAGI Clinical Research Conference West (October 2019)
  • Co-presenter, “Dissecting a Clinical Trial Agreement: Part 1,” MAGI Clinical Research Conference West (October 2018)

Activities & Memberships

  • Member, American Health Lawyers Association (2004 – 2006; 2016 – present)
  • Member, Society of Clinical Research Associates (2022 – present)
  • Former member, National Council of University Research Administrators (2011 – 2016)
  • Former member, Michigan Society of Healthcare Risk Management (2004 – 2006)
  • Board of Directors Member, Washtenaw Literacy (2017 – 2022)

Clerkship & Internships

  • Intern judicial law clerk for the Honorable Denise Page Hood, United States District Court for the Eastern District of Michigan (2003)
  • Law clerk at the University of Michigan, Health Systems Legal Office (2003 – 2004)

Education & Bar Admissions

  • J.D., Wayne State University School of Law, 2004
  • B.A., University of Michigan, 1999
  • Admitted in Michigan (2004)