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.
Managerial professional with proven record of streamlining processes and leading high-performing teams. Known for strong analytical skills and commitment to achieving results. Teams rely on collaborative leadership and adaptability to changing needs.
Overview
20
20
years of professional experience
1
1
Certification
Work History
Senior IRB/SCRO Panel Manager
Stanford University
Palo Alto, CA
08.2022 - Current
- Perform expedited reviewer duties
- Serve as a liason between Board members and PI’s
- Manage two analysts on Panel
- Create SOP’s for Stem Cell Research Oversight (SCRO)
- Oversee the day to day operations of the IRB and associated Stem Cell Research Panel
- Serve as a Non-Scientist IRB Member
Manager Quality Assurance and Regulatory Affairs
Baylor Research Institute, Baylor Scott & White Health
Temple, TX
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
- Perform expedited reviewer duties
- 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
IRB Administrator
IRB Gold, Baylor Research Institute Baylor Scott & White Health
Temple, TX
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
Program Manager
Baylor Research Institute, Baylor Scott & White Health
Temple, TX
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
Temple, TX
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
Temple, TX
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
Clinical Research, Scott and White Healthcare
Temple, TX
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
Bachelor of Arts - Accounting
Central Texas A&M University
Killeen, TX01-2012
Associate of Arts - Business Accounting
Central Texas College
Killeen, TX01-2006
Skills
- Analytical and Critical Thinking
- Policy and Procedure Writing and interpretation
- Adaptable to Changing Conditions
- Complex Problem Solving
- Customer service
- Decision-making
- Staff training and development
Certification
- CIP Certification
- 2015, 2018, 2021, 2024
Timeline
Senior IRB/SCRO Panel Manager
Stanford University
08.2022 - Current
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
Clinical Research, Scott and White Healthcare
10.2006 - 09.2011
Bachelor of Arts - Accounting
Central Texas A&M University
Associate of Arts - Business Accounting
Central Texas College