Dr. Pfeiffer earned her doctorate and master's in Regulatory Science from the University of Southern California International Regulatory Science Program. Recent research include current practices of US investigators in the management of clinical trial agreements. She has an extensive background in clinical trial operations. Her expertise and education also include: regulatory compliance, CFRs, GCPs, HIPAA, budget management, contract management, site audits, performance management, SOPs, protocol, consents, IRB submissions, and regulatory reporting.
Clinical Trial Agreements, contracts, policy, research conduct, investigational drug and device research studies,
Courses
2024 Fall
| Course Number | Course Title |
|---|---|
| HCR 575 | MgmtNegClinTrialBudgetContract |
| HCR 578 | Legal Aspects of Clinical Rsrc |
| RCR 718 | Plan & Execution Clinic Rsrch |
2024 Spring
| Course Number | Course Title |
|---|---|
| HCR 578 | Legal Aspects of Clinical Rsrc |
| HCR 578 | Legal Aspects of Clinical Rsrc |
2023 Fall
| Course Number | Course Title |
|---|---|
| HCR 578 | Legal Aspects of Clinical Rsrc |
| HCR 563 | Regulatory Affairs |
2023 Spring
| Course Number | Course Title |
|---|---|
| HCR 578 | Legal Aspects of Clinical Rsrc |
| HCR 563 | Regulatory Affairs |
| HCR 595 | Continuing Registration |
2022 Fall
| Course Number | Course Title |
|---|---|
| HCR 575 | MgmtNegClinTrialBudgetContract |
| HCR 561 | Conduct of Clinical Research |
| HCR 576 | Drug Discovery,Development&Reg |
| HCR 578 | Legal Aspects of Clinical Rsrc |
| HCR 576 | Drug Discovery,Development&Reg |
| HCR 595 | Continuing Registration |
2022 Summer
| Course Number | Course Title |
|---|---|
| HCR 494 | Special Topics |
2022 Spring
| Course Number | Course Title |
|---|---|
| HCR 578 | Legal Aspects of Clinical Rsrc |
| HCR 494 | Special Topics |
| HCR 578 | Legal Aspects of Clinical Rsrc |
2021 Fall
| Course Number | Course Title |
|---|---|
| HCR 575 | MgmtNegClinTrialBudgetContract |
| HCR 593 | Applied Project |
2021 Summer
| Course Number | Course Title |
|---|---|
| HCR 593 | Applied Project |
| HCR 561 | Conduct of Clinical Research |
| HCR 598 | Special Topics |
2021 Spring
| Course Number | Course Title |
|---|---|
| LAW 667 | FDA Regulation |
| HCR 578 | Legal Aspects of Clinical Rsrc |
| HCR 562 | Data Management & Technology |
| HCR 566 | Research Management Capstone |
| HCR 561 | Conduct of Clinical Research |
| HCR 578 | Legal Aspects of Clinical Rsrc |
2020 Fall
| Course Number | Course Title |
|---|---|
| HCR 563 | Regulatory Affairs |
| HCR 598 | Special Topics |
| HCR 552 | Medical Device Regulation |
| HCR 543 | Food Safety and Protection |
| HCR 543 | Food Safety and Protection |
| HCR 494 | Special Topics |
| HCR 494 | Special Topics |
| HCR 575 | Contracting and Budgeting |
| HCR 565 | Clinical Research Operations |
2020 Summer
| Course Number | Course Title |
|---|---|
| HCR 561 | Conduct of Clinical Research |
| HCR 563 | Regulatory Affairs |
| HCR 568 | Health Care Project Management |
| HCR 561 | Conduct of Clinical Research |
2020 Spring
| Course Number | Course Title |
|---|---|
| HCR 566 | Research Management Capstone |
| HCR 557 | ClinicalResearchDesignMethods |
| HCR 562 | Data Management & Technology |
| HCR 567 | Research Management |
| HCR 558 | Regulatory Writing |
| HCR 553 | Quality and Clinical Research |
| HCR 551 | Clinical Research Monitoring |
| HCR 574 | Science&Research Review Boards |
| HCR 565 | Clinical Research Operations |
| HCR 563 | Regulatory Affairs |
| HCR 558 | Regulatory Writing |
| HCR 553 | Quality and Clinical Research |
| HCR 557 | ClinicalResearchDesignMethods |
| HCR 561 | Conduct of Clinical Research |
| LAW 667 | FDA Regulation |
| HCR 578 | Legal Aspects of Clinical Rsrc |
| HCR 577 | Global Regulatory Affairs |
| HCR 552 | Medical Device Regulation |
| HCR 562 | Data Management & Technology |
| HCR 598 | Special Topics |
| HCR 566 | Research Management Capstone |
| HCR 553 | Quality and Clinical Research |
| HCR 577 | Global Regulatory Affairs |
| HCR 578 | Legal Aspects of Clinical Rsrc |
| HCR 592 | Research |
2019 Fall
| Course Number | Course Title |
|---|---|
| HCR 552 | Medical Device Regulation |
| HCR 575 | Contracting and Budgeting |
| HCR 562 | Data Management & Technology |
| HCR 576 | Drug Discovery,Development&Reg |
| HCR 567 | Research Management |
| HCR 576 | Drug Discovery,Development&Reg |
| HCR 552 | Medical Device Regulation |
| HCR 576 | Drug Discovery,Development&Reg |
| HCR 579 | Trans Rsrch Drug Discovery&Dev |
2019 Summer
| Course Number | Course Title |
|---|---|
| HCR 566 | Research Management Capstone |
| HCR 545 | Biospec Repos Admin |
| HCR 568 | Health Care Project Management |
| HCR 563 | Regulatory Affairs |
| HCR 561 | Conduct of Clinical Research |
| HCR 545 | Biospec Repos Admin |
| HCR 566 | Research Management Capstone |
College of Nursing and Health Innovation - Dream, Discover, Deliver Award for Interprofessional Team (2017)
National Association of Professional Women - Woman of the Year 2012/2013
Association of Clinical Research Professionals - Member at Large; Regulatory Affairs Committee Member; Professional Mentor
Regulatory Affairs Professional Society - Member at Large
Coalition of Academic Clinical Research Programs - Member; co-chair website committee; site visitor/evaluator for academic site's clinical research programs
- Clinical Trial Budgets
- Clinical Trial Agreements
- Efficient Clinical Trial Start-up
- Site Audits
- Study Staff Training
National & International Speaker - conduct of clinical trials, curriculum development, course and program development, professional and educational competencies,
Graduate Certificate: Alternative Dispute Resolution