Alicia Palao
Katy,USA
Summary
Dynamic research professional with a proven track record in spearheading diverse research initiatives and driving impactful outcomes. Expertise in protocol development and regulatory compliance is complemented by advanced data management and analytical skills, ensuring the highest standards of research integrity. Managed over 60 clinical studies and projects, enhancing research outcomes through strategic oversight and effective collaboration across multidisciplinary teams. A strong understanding of the project lifecycle paired with exceptional critical thinking and problem-solving capabilities enables innovative solutions to complex challenges.
Overview
21
21
years of professional experience
Work History
Research Project Manager (Health Disparities Research)
UT MD Anderson Cancer Center
11.2022 - Current
- Managed and implemented scientific research projects to address health disparities, ensuring alignment with research goals.
- Created project budgets and collaborated with internal and external teams to effectively monitor and control expenses.
- Assessed, planned, implemented, and evaluated educational programs and activities for patients and their families.
- Evaluated research data and revised techniques to enhance research quality.
- Supervised staff and trainees assigned to research projects.
- Developed educational patient-facing materials for families, patients, and stakeholders (Sponsors, Harris Health, Harris County, City of Houston, HUD, and collaborating partners with Methodist, UT Health, Harris Health and BCM).
- Served as liaison to patients, families, stakeholders, and sponsors, ensuring effective communication.
- Participated in the development, preparation, and submission of various research/scientific/sponsor progress reports (CPRIT, NIH, DoD, PCORI, ACS, and etc.)
Sr. Research Program Coordinator (GU)
UT MD Anderson Cancer Center
10.2021 - 11.2022
- Coordinated submission of new and revised protocols for FDA IDE/IND and IIT, ensuring adherence to regulatory standards.
- Reviewed and submitted AES, SAEs, SUSARs, and INDs, ensuring timely compliance with institutional reporting requirements.
- Supervised protocol annual review process and IND/IDE status reports, providing critical toxicity information to support compliance.
- Prepared documentation for study monitoring and audit visits to ensure compliance.
- Addressed and corrected findings from study monitoring and audit visits efficiently.
- Edited informed consent forms to align with specific protocols.
Research Program Coordinator (Melanoma)
UT MD Anderson Cancer Center
01.2019 - 01.2021
- Coordinated development and activation of protocols for Phase 1-4 trials, post-market trials, device trials, pilot trials, and Investigator Initiated IND/IDE trials.
- Executed comprehensive quality assurance plans for clinical trial activities, ensuring compliance with protocols, SOPs, ICH GCP, and regulatory requirements.
- Facilitated submission and approval processes for 13 IIT studies, securing FDA/IND/IRB approvals during tenure.
Sr. Regulatory Affairs Coordinator/Research Manager
Baylor College of Medicine
02.2015 - 12.2018
- Supported execution of clinical research studies, encompassing investigator-initiated trials and phases 1 through 4, including medical devices and post-FDA approval evaluations at BCM and affiliates, including BSLMC, VA, Ben Taub, and Methodist.
- Increased research capacity by broadening core from 10 to over 100 studies/projects within a two-year timeframe.
- Negotiated Clinical Trial Agreements (CTAs) and prepared budgets for clinical trials, ensuring compliance and resource allocation.
- Supported research advancement through the development of IND protocols and additional sponsored protocols.
- Developed and maintained regulatory documentation for clinical trials to ensure compliance with federal regulations, such as the IRB and FDA.
Sr. Clinical Research Manager
Novum Pharmaceutical Research Services
08.2011 - 02.2015
- Supervises the conduct of clinical studies: acts as liaison between site personnel and the sponsor; performs monitoring in the field; ensures compliance with protocols, regulatory requirements, and good clinical practices; writes follow-up visit reports.
- Covered many therapeutic areas including Oncology, CNS, Internal Medicine, General Medicine, and Surgery, and Pediatrics.
Senior Research Coordinator
Baylor College of Medicine
09.2008 - 04.2011
- Coordinate and participate in clinical research studies conducted by principal investigator(s) at the Parkinson's Disease Center and Movement Disorder Clinic, (PDCMDC) at Baylor College of Medicine.
- Studies vary from phase 1 to phase 4.
Senior Evaluator/Process Monitor
DePelchin's Children Center
08.2006 - 02.2008
- Design, create and maintain databases using case tools and software (e.g. SPSS, MS Office, Teleform, ECHO, CCKids, and ACCESS).
- Apply mathematical operations to frequency distributions, reliability, and validity of tests, normal curve, analysis of variance, correlation techniques, chi-square application and sampling theory.
Research Analyst/Consultant
Boston Public Health Commission
09.2005 - 01.2006
- Maintaining databases (EPI-INFO and CDC software) and Grant Writing (NIH).
- Producing Evaluation Reports for city meetings/Summarizing databases for city report.
Senior Research Coordinator
Xavier University of Louisiana
01.2005 - 01.2006
- Responsible for maintaining all databases for research (SPSS, STATA, and Access).
- Experience with NIH, NIAAA, and other federal grants.
Education
M.A. - Sociology, Statistics
University of Houston
05-2004
B.A. - Sociology, Psychology
University of New Orleans
12-2001
Skills
- Microsoft Office (Excel, Word, PPT, Access, Teams)
- REDCAP
- EMR management and Epic
- DatStat and Medidata
- BioClinical and Velos
- Rave and Oracle
- QuickBase and FileMaker
- Cloud Storage
- STATA, SPSS, and Epi Info
- AI Tools (ChatGPT, Gemini, Claude)
Timeline
Research Project Manager (Health Disparities Research)
UT MD Anderson Cancer Center
11.2022 - Current
Sr. Research Program Coordinator (GU)
UT MD Anderson Cancer Center
10.2021 - 11.2022
Research Program Coordinator (Melanoma)
UT MD Anderson Cancer Center
01.2019 - 01.2021
Sr. Regulatory Affairs Coordinator/Research Manager
Baylor College of Medicine
02.2015 - 12.2018
Sr. Clinical Research Manager
Novum Pharmaceutical Research Services
08.2011 - 02.2015
Senior Research Coordinator
Baylor College of Medicine
09.2008 - 04.2011
Senior Evaluator/Process Monitor
DePelchin's Children Center
08.2006 - 02.2008
Research Analyst/Consultant
Boston Public Health Commission
09.2005 - 01.2006
Senior Research Coordinator
Xavier University of Louisiana
01.2005 - 01.2006
B.A. - Sociology, Psychology
University of New Orleans
M.A. - Sociology, Statistics
University of Houston
Career Skills
- Prepare agendas, materials, minutes, track attendance and manage meeting requests
- Independently manage work deadlines and manage SharePoint sites with documents
- Assist in preparing scientific publications, conducting literature reviews, writing educational content, design modules, ensure compliance, and maintain documentation
- Coordinate study activities, prepare research materials, recruit participants, conduct interviews, maintain data quality, and train staff
- Writes and edits abstracts, syllabi, manuscripts, publications, grants, and clinical/translational protocols.
- 6 years of experience administering grants (NIH, DoD, CPRIT, ACS, PCORI, foundation/philanthropic) and contracts, pre-award (developing budgets, assisting in application preparation, etc.) and post award (monitoring expenditures, preparing financial reports for faculty, effort reporting, etc.)
- ACRP, SOCRA, CCRC, CCRP, RAC, and PMP eligible/pending
- Familiar with Sponsored Programs Office and CTMS (electronic regulatory systems).
- Project management skills
- Budget management and contract negotiation
- Regulatory and compliance monitoring
- Protocol development and Survey design
- Proposal writing
- Training supervision