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.
• 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.
• 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.
• 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.
• 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

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.
• 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.
• 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.
• 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.
• 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.

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.
• 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.
• 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.
• 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.

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.
• 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.
• 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

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.

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