Lana Gevorkyan
Brighton,USA
Summary
Accomplished healthcare leader with expertise in regulatory compliance and research infrastructure. Demonstrated success in developing harmonized workflows and optimizing research operations, ensuring adherence to regulatory standards and enhancing organizational research capabilities.
Overview
24
24
years of professional experience
Work History
DIRECTOR, IRB COORDINATED SERVICES/PRACTICES AND STRATEGIC PARTHERSHIPS
University of Michigan
Ann Arbor, MI
01.2022 - Current
- Strengthened collaboration across Ann Arbor and U-M Network of Care sites to enhance research initiatives
- Works with external clinical and academic affiliates to assess regulatory and personnel readiness to engage in human research activities with the University of Michigan Ann Arbor
- Oversee and track progress toward research infrastructure development at UM and affiliates
- Conducted regulatory assessments and evaluated research infrastructure readiness to support human research activities
- Collaborate closely with academic, clinical and research leaders to support the initiation of research collaborations with the affiliates
- Assesses relationships, metrics, and research functionality for success and necessary adjustments
- Contributed to development of electronic systems improving research capabilities and streamlining processes
- Serves as a key partner and liaison on various research initiatives
- Develop and implement harmonized workflows between University of Michigan IRBs
INDEPENDENT CONSULTANT
HRP Consulting
Lake Success, NY
01.2016 - 12.2022
- Delivered expert support to research professionals nationwide, offering services that enhance healthcare organizations' ability to meet their goals.
- Facilitated AHRPP accreditation for healthcare organizations, ensuring compliance with regulatory standards.
- Developed and implemented Human Research Protection Program (HRPP) strategies to safeguard participant welfare and ensure ethical research practices.
- Research Office Set-up
- Policy Development
- Regulatory Compliance
- Quality Improvement/Post Approval Monitoring
ASSISTANT DIRECTOR, IRBMED
University of Michigan
Ann Arbor, MI
04.2019 - 01.2022
- Collaborated with Director, Co-Chairs, AVP for Research, and senior leadership to align regulatory practices with strategic goals.
- Led regulatory staff, providing expertise to foster a compliant and efficient operational environment.
- Oversaw programmatic initiatives and executed strategies to strengthen regulatory compliance across the department.
- Provided direct oversight to regulatory teams and responsible for for the functional and efficient operations of the department
- Worked with regulatory staff to develop best practices and workflows to improve metrics while being competitive with peer benchmarks/national standards
- Contributed as a key member on initiatives and committees.
- Co-presented at PRIM&R and University’s various educational platforms
DIRECTOR, CORPORATE RESEARCH ADMINISTRATION
McLaren Healthcare Corporation
Auburn Hills, MI
10.2016 - 09.2018
- Provided system-wide leadership, administration, and strategic direction on all research initiatives to support research at McLaren
- Oversaw implementation and performance of system-wide research initiatives, ensuring alignment with strategic goals.
- Provided strategic input to the Vice President of Clinical Excellence and Research in implementation and management of institutional policies and procedures related to research at McLaren
- Served as a liaison to sponsors and regulatory agencies, research subjects, IRB members, and investigators to facilitate research compliance and collaboration.
- Led all research operations throughout the McLaren system and was responsible for ongoing development of system-wide research
- Developed operational strategies for the efficient and effective functioning of research across the system
- Established and led system-wide research committees to enhance oversight and foster growth of research initiatives.
CORPORATE DIRECTOR, Human Research Protections Program
McLaren Healthcare Corporation
Auburn Hills, MI
01.2011 - 10.2016
- Led the creation and overall leadership of the system-wide Human Research Protections Program [HRPP]
- Spearheaded a system-wide IRB to oversee research across the organization
- Achieved system-wide accreditation in human research protections [AAHRPP] which included multiple hospitals
- Developed and implemented policies and procedures ensuring compliance with federal, state, and local regulations, enhancing research integrity
- Developed and implemented a system-wide research compliance program to ensure quality improvement
- Collaborated with departments and management to expand system-wide research infrastructure, fostering a robust environment for research activities
- Supported Vice President of Research in strategic development of system-wide research vision, aligning initiatives with organizational goals
- Mentored and coached staff resulting in a 30% increase in productivity
- Served as a primary contact for the regulatory agencies including FDA and OHRP
- Oversaw departmental budget management
MANAGER OF REGULATORY AFFAIRS
Michigan State University
East Lansing, MI
08.2008 - 12.2010
- Managed regulatory operations to ensure compliance with SOPs, GCP guidelines, and sponsor regulations.
- Provided direction and leadership to all research staff regarding regulatory requirements
- Developed and implemented regulatory component for clinical trials office to ensure adherence to regulatory standards.
- Communicated with Executive Directors, Managers, and Investigators to effectively resolve regulatory issues and ensure project progression.
- Acted as a liaison to pharmaceutical companies and regulatory agencies.
- Conducted Internal Quality Assurance Reviews
- Developed and implemented standard operating procedures (SOPs).
LEAD REGULATORY SPECIALIST
Michigan State University
East Lansing, MI
04.2006 - 08.2008
- Coordinated and submitted document packages to committees, ensuring compliance with regulatory requirements.
- Ensured regulatory compliance and GCP adherence within the research office
- Maintained regulatory research records for multiple protocols across 15 affiliate sites, supporting accurate compliance tracking.
- Developed and implemented standard operating procedures
- Developed an educational and training program to strengthen the efficiency of the regulatory department
- Mentored team members on day-to-day tasks, enhancing overall team competency and performance.
REGULATORY SPECIALIST
Michigan State University
East Lansing, MI
03.2003 - 03.2006
- Prepared applications, revisions, consent forms, and other regulatory documents for compliance with regulatory standards
- Assisted with external and internal audits to ensure adherence to regulatory requirements and improve compliance processes
- Facilitated study monitoring visits to support regulatory compliance and ensure proper oversight of clinical trials.
- Created and maintained regulatory information system to manage system wide oncology documents in the informed consent process
- Organized regulatory management system for the oncology network
SENIOR RESEARCH ADMINISTRATOR
Medical College of Wisconsin
Milwaukee, WI
05.2002 - 02.2003
- Managed the regulatory compliance and GCP adherence
- Liaised with regulatory agencies and pharmaceutical companies to facilitate compliance and communication
- Implemented policies and procedures to streamline compliance and operations
- Coordinated clinical research activities, supporting study execution and participant management
- Led multiple projects through all research phases, ensuring successful study initiation and closure
Education
MBA - Healthcare Administration
Davenport University
Livonia, Michigan, USA01-2020
Bachelor of Science - Case Management
Davenport University
Warren, Michigan, USA01-2013
Skills
- Regulatory knowledge
- Human Research Compliance
- HIPAA/Research Compliance
- SOP Development
- Quality Assurance
- Project management
- Program development
- Operational Efficiency
- Metrics-driven
- Data analysis
- Research Policy Development
- Departmental Operations
- Relationship building
Activities And Memberships
- Chair, Conflict of Interest Committee in Research, 2012 - 2018
- Chair, Research Marketing Committee, 2013 - 2018
- Chair, Clinical Research Associate Research Council, 2016 - 2018
- Member, Primary Responsibility in Research and Medicine, 2011 - current
- Member, Michigan Ethics Research Committee, 2013 - 2016
- Member, Society of Clinical Research Associates, 2003 - 2010
Timeline
DIRECTOR, IRB COORDINATED SERVICES/PRACTICES AND STRATEGIC PARTHERSHIPS
University of Michigan
01.2022 - Current
ASSISTANT DIRECTOR, IRBMED
University of Michigan
04.2019 - 01.2022
DIRECTOR, CORPORATE RESEARCH ADMINISTRATION
McLaren Healthcare Corporation
10.2016 - 09.2018
INDEPENDENT CONSULTANT
HRP Consulting
01.2016 - 12.2022
CORPORATE DIRECTOR, Human Research Protections Program
McLaren Healthcare Corporation
01.2011 - 10.2016
MANAGER OF REGULATORY AFFAIRS
Michigan State University
08.2008 - 12.2010
LEAD REGULATORY SPECIALIST
Michigan State University
04.2006 - 08.2008
REGULATORY SPECIALIST
Michigan State University
03.2003 - 03.2006
SENIOR RESEARCH ADMINISTRATOR
Medical College of Wisconsin
05.2002 - 02.2003
MBA - Healthcare Administration
Davenport University
Bachelor of Science - Case Management
Davenport University