Andrea C. Klaver, Mba, Chrc®, Cip® Email & Phone Number

Boston, Massachusetts, United States

• Conduct expedited reviews of submitted human subject research applications in accordance with federal requirements, Human Research Office (HRO) policies, and procedures and accreditation standards• Work with personnel in all areas of the submission and review process to ensure appropriate screening and review of research documents, and provide support to research staff on research submissions, training requirements, and updated processing procedures• Independently understands and applies the federal and state regulations for human subjects research to studies submitted for category determination to ensure adherence to regulatory and ethical standards• Responsible for determining when an activity meets the definition of human subject research under federal regulations and determine when research is exempt under the federal regulations

Houston, Texas, United States

• Support the HRP Office (HRPO) and the Institutional Review Boards (IRB) and is responsible for the comprehensive analysis of clinical study protocols, clinical study reports (CSRs), and other associated submissions for completeness, consistency, and compliance with regulations, guidelines, and institutional policies in preparation for IRB review using Huron IRB web-based software• Responsible for running 1 of Houston Methodist's 3 IRB meetings, once per month, including agenda preparation, disseminating pertinent documentation to members prior to the meeting, maintaining quorum and vote totals, documenting motions and controverted issues, HIPAA waiver documentation, Cognitively Impaired Adults (Legally Authorized Representative) documentation of use, and prepare meeting minutes and other correspondence letters that reflect the committee’s determinations, while ensuring that written information and committee determinations and determination letters are accurate and complete post-meeting• Mentor and provide guidance and training to junior Human Research Protections staff• In preparation for IRB designee or committee review, gather additional data as necessary from researchers, study staff, and others and provide appropriate guidance to researchers and IRB members to ensure the protection of human subjects in research• Using the regulations and institutional policies as a guide, advise investigators and study teams of potential gaps in protocol submissions, including associated documents, and suggest solutions to facilitate research• Advise and provide input to HRP IRB Coordinators and other research stakeholders on the interpretation of regulations and guidance from oversight authorities, compliance matters, and institutional processes• Provide support to HRP leadership in the management of various committee regulatory reviews while prioritizing and planning my workload to a high standard and effectively managing multiple assignments simultaneously

Auburn Hills, Michigan, United States

• Ensure the proper review and timely processing of research IRB submissions via iRIS by Cayuse iMedRIS, our web-based, electronic IRB submission system, including Full Board, Expedited, and Exempt initial submissions, continuing reviews, modifications, violations, UPIRSO, and final reports• Maintain current understanding and interpretation of Federal regulations (FDA; OHRP; HIPAA), state laws, local laws, and Human Research Protection Program (HRPP) policies • Apply ethical principles and standards to human subject research proposals including the protocol, informed consent form (ICF), and other study‐related documents while reviewing submissions and recommending revisions to work instructions, guidance, checklists, forms, and other documents to ensure regulatory compliance• Attend and run IRB committee meetings, participate in discussion, and prepare meeting minutes and other correspondence that reflect the committee’s determinations as assigned, while ensuring that written information and committee determinations and determination letters are accurate and complete post-meeting• Route information and communicate study‐related findings to the Principal Investigator (PI) or other designated individuals as appropriate throughout the review process and explain to the PI any pre‐approval, post‐approval, or other required modifications related to a research study while processing large volumes of complex work through prioritization, organization, and demonstrating flexibility and willingness to adjust priorities as necessary to meet conflicting demands• Conduct preliminary review of all unanticipated problems involving risk to subjects or others, noncompliance reports, and new information to determine whether a risk mitigation or corrective and preventive action plan (CAPA) is required

Auburn Hills, Michigan, United States

• Develop and implement a comprehensive clinical research compliance auditing plan to be completed each fiscal year: o For FY20 and FY21, despite unexpected staffing losses and other challenges due to COVID-19, all compliance plan activities were completed on schedule o Creative solutions were implemented to overcome prohibited face-to-face interactions that are typical of compliance audit activities o FY20: 25 routine audits of studies (including 11 medical resident studies), 5 clinical trial agreement (CTA) audits, and 12 IRB meeting minute QA audits were performed o FY21: 15 routine audits of studies (including 2 medical resident studies), 5 clinical trial agreement (CTA) audits, 14 IRB meeting minute QA audits, 3 informed consent form (ICF) audits were performed• Record and monitor all research compliance activities in ComplyTrack, our regulatory risk and compliance software• Assist the Director of Corporate Research Administration with the AAHRPP re-accreditation process• Facilitate the execution of system-wide training programs, workshops, and conferences for investigators, IRB members, and research staff in the form of 2x quarterly interactive webinars (“Brown Bag Sessions” and “IRB Education Sessions”), quarterly written articles (“Research Matters Newsletter”), and newsletters/e-blasts highlighting regulatory compliance policies and best practices in human research protections• Responsible for the development and presentation of an employee-wide curriculum to support the on time go-live transition from one electronic Institutional Review Board (IRB) document management system (eProtocol) to another (iRIS by iMedRIS)• Participate in developing and implementing policies, procedures, and guidelines to ensure continued compliance, while also ensuring minimum administrative burden on researchers and administrators and maintaining the highest ethical standards

Royal Oak, Michigan, United States

• Integral in the implementation and migration of annual compliance education modules from one web-based LMS to another, while managing large (>5,000) user rosters, demographic feeds, and employee and non-employee mapping to successfully meet the annual program launch go-live deadline for 3 consecutive years• Interfacing with clinical and bench researchers, ensure proper research oversight and promote best practices via the iMedRIS electronic document management system with the internal IRB (Institutional Review Board) and ACC (Animal Care Committee)• Utilizing medical and insurance terminology, formulate institutional policy and process documentation to ensure data integrity while documenting Medicare research billing and reimbursement• Prepare for federal documentation audits (i.e. AAHRPP), monthly, and quarterly internal audit reports• Relentless participation in continuing education opportunities including new certifications as needed (i.e. CHRC)

Royal Oak, Michigan, United States

Promoted multiple times for outstanding performance & leadership skills.• With Accounting, Sales Representatives, and other internal stakeholders, planned, managed, and executed accounting budgets and all restricted funds related to neurology bench research for over 50 projects annually• With Outcomes Research, generated preliminary evidence, designed, and implemented protocols from study conceptualization to final report and data analysis and dissemination on over 15 studies annually• Assisted Accounts Payable and Purchasing with invoices, orders, capital item contracts, & vendor payment• Composed 5 capital budgeting equipment contracts with Vendors to deliver on-budget results• Proactively developed operational improvements and clinical laboratory efficiencies• Provided direction and strategic input in conjunction with Primary Investigator• Wrote SOPs, federal and philanthropic grants, peer-reviewed manuscripts, scientific posters and abstracts for presentation, and regulatory process documents• Involved in the creation of a comprehensive business plan for the Beaumont Health Neuroscience Department

Ann Arbor, Michigan, United States

• Ensured product quality; produced materials accurately and consistently in accordance with good manufacturing practices; maintained, tracked, and organized laboratory inventory according to standard operating procedures in an industrial environment

Troy, Michigan, United States

• Answered phones and interacted with clients of diverse backgrounds as first point of contact while entering data into computer spreadsheets and manipulating large databases of Medicaid contract funding

Master Of Business Administration (Mba), Business Administration And Management, General, 3.9 Cumulative

Bachelor Of Science (Bs), Microbiology, General, 3.6 Cumulative