Tracy Wilcox
Salado,TX
Summary
Highly organized and detail-oriented IRB professional excels in office management and special projects. Resourceful and adaptive team leader with expertise in project management, customer relationship and management. Results-oriented strategic planner with extensive knowledge of FDA regulations, HIPAA laws and IRB coordination.
Overview
19
19
years of professional experience
1
1
Certification
Work History
Human Research Protection Program Manager
Stanford University
01.2025 - Current
- Managed and motivated employees to be productive and engaged in work.
- Oversee day to day operations of 4 IRB's (two convened and two expedited)
- Evaluate and update SOP's as needed
- Interview and hire new staff
- Serve as Non-Scientist IRB Member
- Provide continuing education for current Panel managers
- Educate and OnBoard new Panel Managers and IRB Members
Senior IRB/SCRO Panel Manager
Stanford University
08.2022 - 01.2025
- Maximized performance by monitoring daily activities and mentoring team members.
- Perform expedited reviewer duties
- Create SOP's for Stem Cell Research Oversight (SCRO)
- Oversee day to day operations of the IRB and associated Stem Cell Research Panel
- Serve as a liaison between IRB members and Researchers
- Cross-trained existing employees to maximize team agility and performance.
- Serve as a Non-Scientist IRB Member
IRB Administrator/IRB Member
IRB Blue, White, Red and Gold, Baylor Research Institute, Baylor Scott & White Health
03.2021 - 08.2022
- Perform expedited reviewer duties
- Oversee day to day operations of 4 IRB's (three convened and one expedited)
- Serve as a liaison between Board members and PI's
- Responsible for recruiting and educating new Board members
- Permanent voting member on all 4 IRB's
- Serve as a liaison in FDA audits and AHRPP accreditation visits
Manager Quality Assurance and Regulatory Affairs
Baylor Research Institute, Baylor Scott & White Health
03.2021 - 08.2022
- Responsible for aligning four IRB's operations for integration
- Responsible for the day to day operations of four IRB's
- Responsible for educating team members in alignment operations
- Created SOP's to direct integration
IRB Administrator
IRB Gold, Baylor Research Institute Baylor Scott & White Health
01.2018 - 03.2021
- Oversee the day to day operations for IRB
- Perform expedited reviewed duties
- Serve as a liaison between Board members and PI's
- Responsible for recruiting and educating new Board members
- Permanent voting member on IRB
- Serve as a liaison in FDA audits and AHRPP accreditation visits
- Handled sensitive information discreetly, maintaining strict confidentiality at all times as required by company policy or legal regulations.
Program Manager
Baylor Research Institute, Baylor Scott & White Health
07.2015 - 03.2021
- Oversee day to day operations of IRB
- Review workload of IRB analysts
- Educate and onboard new IRB analysts
IRB Member
IRB, Baylor Research Institute, Baylor Scott & White Health
01.2015 - 03.2021
- Review assigned projects for presentation at meeting, includes new studies, revisions, continuing reviews and any full board deviations.
- Presented assigned projects to full board in detail
Research Compliance Analyst
Scott and White Healthcare
09.2011 - 07.2015
- Responsible for daily operations of one Full Board, including but not limited to: expedited revisions, acknowledgements of PD/SAE/IND, pre-review of new protocols, agenda prep, meeting prep and close out, meeting minutes, member education and training.
- Process expedited and exempt studies
- Created checklists in order to ensure pre-review is conducted thoroughly
- Created approval letters
- Assist investigators with IRB submission
Research Coordinator
Scott and White Healthcare
10.2006 - 09.2011
- Prepare submissions for IRB review
- Conduct studies according to protocol.
- Serve as a liaison between monitors and investigators
- Recruit subjects
- Create budgets
- Train new coordinators
Education
BA - Accounting
Central Texas A&M University
Killeen, TX01.2012
AA - Business Accounting
Central Texas College
Killeen, TX01.2006
Skills
- Adaptable to Changing Conditions
- Documentation and Recordkeeping
- Willingness to Learn
- Decision Making
- Complex Problem Solving
- Decision-making
- Time management
- Team leadership
- Customer service
Certification
CIP Certification, 2015, 2018, 2021, 2024
Timeline
Human Research Protection Program Manager
Stanford University
01.2025 - Current
Senior IRB/SCRO Panel Manager
Stanford University
08.2022 - 01.2025
IRB Administrator/IRB Member
IRB Blue, White, Red and Gold, Baylor Research Institute, Baylor Scott & White Health
03.2021 - 08.2022
Manager Quality Assurance and Regulatory Affairs
Baylor Research Institute, Baylor Scott & White Health
03.2021 - 08.2022
IRB Administrator
IRB Gold, Baylor Research Institute Baylor Scott & White Health
01.2018 - 03.2021
Program Manager
Baylor Research Institute, Baylor Scott & White Health
07.2015 - 03.2021
IRB Member
IRB, Baylor Research Institute, Baylor Scott & White Health
01.2015 - 03.2021
Research Compliance Analyst
Scott and White Healthcare
09.2011 - 07.2015
Research Coordinator
Scott and White Healthcare
10.2006 - 09.2011
BA - Accounting
Central Texas A&M University
AA - Business Accounting
Central Texas College
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