MARION B. OLSON
Houston,TX
Summary
Seeking a position of strategic leadership in the human subjects research regulation field where I can use my 18 years of experience. Highly organized and self-motivated human subjects research expert experienced in team development and process improvement. Skilled in developing and implementing strategies to increase efficiency in IRB workflows while maintaining regulatory compliance. Passionate about developing collaborations across teams and creating a positive work environment.
Overview
24
24
years of professional experience
1
1
Certification
Work History
Manager, IRB
Houston Methodist
03.2024 - Current
- Manage staff of 9 Human Research Protection (HRP) Analysts to ensure appropriate regulatory review of research studies
- Ensure established review timelines are met for study activation
- Work closely with the 3 IRB Chairs and respective boards to ensure appropriate regulatory determinations are made
- Work closely with the Director, Regulatory Services to further enhance the IRB program
- Sustain and develop relationships with key stakeholders such as research departments and research faculty
Executive Director
Salus IRB, Versiti Clinical Trials
06.2023 - 03.2024
- Works closely with Vice President to guide operational strategy.
- Builds and maintains relationships with key clients, vendors, and partners to secure support for organization.
- Fosters work culture of collaboration and inclusion to increase morale and reduce turnover.
- Exercises appropriate cost control to meet budget restrictions and maximize profitability.
- Builds and maintains strong company teams by hiring and training qualified staff to create positive and productive work environments. Mentors staff on regulatory requirements and encourages professional growth through education initiatives via PRIM&R, OHRP, FDA
- Meets with and provides regulatory guidance to clients
Associate Director - Institutional Review Board
University Of Texas MD Anderson Cancer Center
02.2019 - 10.2019
- Oversight of processes and functions related to the IRBs including IRB Staff. Led 4 teams of up to 18 personnel, supervising daily performance as well as training and improvement plans
- Collaborated with and strengthened relationships with departments within the Division of Clinical Research and with other institutional departments (customers) to increase efficiencies in workflows, which decreased IRB review times
- Built and strengthened relationships with vendor representatives and institutional teams in order to continue the development of eResearch (protocol document submission platform)
- Mentored and collaborated with IRB staff and IRB members to ensure compliance with regulations and for buy-in with changes to IRB workflows for increased efficiencies
Manager, Institutional Review Board
University Of Texas MD Anderson Cancer Center
03.2014 - 02.2019
- Tracked workflows and identified bottlenecks specific to protocol amendment submissions - approximately 350 clinical trial amendments submitted monthly
- Assisted with analysis of non-compliance issues including events reportable to Office for Human Subjects Protection (OHRP) and Food & Drug Administration (FDA)
- Assisted, and provided resolutions to concerns from Principal Investigators and research teams regarding IRB reviews and timelines
- Maximized performance by monitoring daily activities and mentoring team members. Adjusted staffing model through job assignments and schedules to keep pace with dynamic institutional needs, factoring in processes, employee knowledge and customer demands.
- Active participation as a subject matter expert in the development of electronic systems that facilitate the IRB review workflow (eResearch)
Supervisor, Institutional Review Board
University Of Texas MD Anderson Cancer Center
03.2007 - 03.2014
- Directly supervised 6 IRB Coordinators. Four (4) IRB Coordinators supported the MD Anderson’s 4 IRBs – 3 clinical and 1 social, behavioral, education & research, and the corresponding ad-hoc committees, Two IRB Coordinators reviewed and processed reportable new information and minimal risk research
- Reviewed IRB agendas prior to the meetings. Approximately 20-25 protocol-related full board items in addition to approximately 16 full board Continuing Reviews were included in IRB agendas for each meeting
- Participated in meetings as a subject matter expert for the development of eResearch
- Assisted with the development of educational initiatives with regards to the IRB policies – OPR Brown Bags and IRB Member Orientation and educated through presentations
Research Administration Compliance Specialist/IRB
University Of Texas MD Anderson Cancer Center
12.2005 - 03.2007
- Reviewed approximately 40-50 protocol amendments per month
- Communicated with Principal Investigator (PI) and research teams in order to maintain excellent customer service
- Was specific point of contact for the Phase 1 department for all protocol amendments
Research Administration Compliance Specialist/IRB Coordinator
University Of Texas MD Anderson Cancer Center
02.2003 - 08.2004
- Supported and facilitated the meetings for a clinical IRB and corresponding ad-hoc committee
- Reviewed approximately 20 protocol amendments per month requiring full board review
- Communicated with Principal Investigators and research teams regarding IRB committee outcomes
Senior Coordinator of Research Data
University Of Texas MD Anderson Cancer Center
07.2000 - 02.2003
- Worked directly with Waun Ki Hong, M.D., a lung cancer research expert
- Maintained regulatory documentation for 30 protocols
- Communicated with the MD Anderson IRB and pharmaceutical companies (sponsors) regarding protocol document submissions
- Coached co-workers through day-to-day work and complex problems related to regulations and IRB submissions
- Aided co-workers, colleagues, managers, and outside sponsors through regular communication and assistance.
Education
Bachelor of Science - Biology
California State University - Long Beach
Long Beach, CA06.1994
Skills
- Human Subjects Research Regulations
- Set Organizational Policies
- People Management
- Issue Resolution
- Project Management
- Staff Management
Accomplishments
- Assisted in the implementation of the 2018 Common Rule for the MD Anderson IRB
- Over 10 years of experience in a direct leadership role
- Achieved decrease time from protocol submission to IRB approval by developing efficient workflows.
- Achieved positive working relationships with customers (Principal Investigators , research teams, industry sponsors, other institutional departments, private research centers) through increased communications and collaborations
- Collaborated with teams across MD Anderson in the development of eResearch, the IRB regulatory platform.
- Assisted in change management plan for implementation of eResearch.
- Led a project team for the implementation of IRB Manager in early Q1 2024 for Salus IRB
Certification
- Certified Institutional Review Board Professional (CIP), attained Sept. 2008 (in process of recertification)
- Certified Clinical Research Professional (CCRP), attained Sept. 2010 (in process of recertification)
Timeline
Manager, IRB
Houston Methodist
03.2024 - Current
Executive Director
Salus IRB, Versiti Clinical Trials
06.2023 - 03.2024
Associate Director - Institutional Review Board
University Of Texas MD Anderson Cancer Center
02.2019 - 10.2019
Manager, Institutional Review Board
University Of Texas MD Anderson Cancer Center
03.2014 - 02.2019
Supervisor, Institutional Review Board
University Of Texas MD Anderson Cancer Center
03.2007 - 03.2014
Research Administration Compliance Specialist/IRB
University Of Texas MD Anderson Cancer Center
12.2005 - 03.2007
Research Administration Compliance Specialist/IRB Coordinator
University Of Texas MD Anderson Cancer Center
02.2003 - 08.2004
Senior Coordinator of Research Data
University Of Texas MD Anderson Cancer Center
07.2000 - 02.2003
Bachelor of Science - Biology
California State University - Long Beach
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