Heather Aman

Experience

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  University of Michigan

  Jun 2014 - Jul 2015

  Laboratory Manager & Technician

  • Lab Manager: Organize and implement lab ordering processes, track inventory, assess and schedule periodic repair and maintenance for lab equipment• Radiation Safety Officer: Responsible for periodic review of inventory, contamination testing, radioactive waste disposal, and reporting• Compliance: Oversee, audit, and follow-up on inspections of lab practices, personnel, and equipment by the university or third parties• Protocol Development: Review the literature and develop novel protocols for anaerobic growth and protein purification, and analysis of enzyme kinetics in microbial carbon dioxide and carbon monoxide metabolism• Recognition and Excellence: Proposition and coordination of lab efforts to earn our team certification with the University of Michigan’s Sustainable Lab Recognition Program• Public Speaking: Contribute to Ragsdale Laboratory Journal Club, a bi-weekly review of current topics in organometallic biochemistry, by building and presenting topically relevant lectures to peers and Principal Investigators Show less

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  Karmanos Cancer Institute

  Jul 2015 - Nov 2017

  Senior Pre-Award Specialist

  • Draft and Negotiate Budgets and Payment Terms: Generate budgets and contracts for oncology research studies from clinical trial protocols and negotiate with pharmaceutical sponsors or CROs• Financial Conflict of Interest (FCOI) Project Lead: Initiate meetings with Principal Investigators and key personnel to manage financial conflicts, coordinate FCOI training, and report disclosures to the IRB• Feasibility Committee Member: Research Finance representative for the Feasibility Review and Operations Committee, assess the feasibility of operating clinical trials at Karmanos Cancer Center and satellite locations• Contract Negotiation: Negotiate Material Transfer Agreements (MTAs) for numerous cell lines owned by Karmanos Cancer Center with interested researchers• Compliance: Maintain updates to ICH-GCP and regulatory training, analyze medical billing practices for Centers for Medicaid & Medicare Services qualification and FDA compliance Show less

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  Henry Ford Health

  Nov 2017 - Oct 2019

  Senior Clinical Research Coordinator

  • Manage Financials: Responsible for clinical trial financials, including budget drafting and negotiation, Epic (EMR) charge review, invoicing, and rectifying ClinCard transactions• Human Subjects Management: Recruit, screen, and enroll patients in clinical research trials; subsequently monitor patients for compliance and adverse events following all requirements outlined in the trial protocol• Maintain Data Integrity: Collect and report clinical trial data (EDC/CRF), and utilize interactive voice/web response systems (IVRS/IWRS)• Compliance: Manage regulatory documentation and Institutional Review Board (IRB) submission; maintain updates to ICH-GCP and regulatory training; analyze medical billing practices for Centers for Medicaid & Medicare Services qualification and FDA compliance• Coordinate Study Conduct: Maintain logs and inventory of study supplies, dispense and reconcile study medication, and ensure appropriate handling of investigational materials• Collaboration: Provide on-site coordination with sponsors and investigators; train new hires; build and deliver training presentations for clinical support staff Show less

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  Huron

  Oct 2019 - now

  Sr. Clinical Research Associate

  • Project Management: Onboard and manage multiple clients as Client and/or Budget Line Lead. Train and coordinate a pool of drafters to build deliverables. Track and analyze metrics across the drafter pool to optimize processes and reduce turnaround times. Lead weekly meetings with client leadership to measure performance, solicit feedback, and anticipate and increase deliverable volume.• Draft/Negotiate Budgets, Payment Terms, and Medicare Coverage Analyses: Draft high complexity clinical trial budgets and payment terms across disease types, and coordinate negotiations across multiple clients. Redline and negotiate sponsor budgets for inclusion in agreements for billable projects, including Industry-Sponsored, Federally Funded, and Foundation Research Grant budgets. Draft protocol-specific Medicare Coverage Analyses with expertise in referencing applicable guidelines and criteria, compendia, and NCD 310.1.• Training Design and Facilitation: Design and conduct training on fundamentals of budget drafting and negotiation, clinical trial logistics, client preferences, and managing the timely submission of deliverables.• Meeting Facilitation: Manage and lead meetings internally, and externally with clients or pharmaceutical sponsors/CROs to exchange accurate, clear information in a professional manner. Draft effective value propositions to mitigate negotiation standstills and maintain client satisfaction and standards.• Draft Professional Documents: Draft and peer edit SOPs, guidance documents, templates, meeting agendas, and pricing/reference tools. Run and analyze Salesforce reports to share results for engagement monitoring and deliverable progress. Show less