Perla Ramirez
Kingwood
Summary
Clinical trials manager with extensive experience at ICON, specializing in study activation and regulatory compliance. Demonstrated success in optimizing trial operations and enhancing stakeholder engagement, resulting in improved oncology research outcomes. Proficient in document management and cross-functional collaboration, ensuring timely project milestones and adherence to GCP standards.
Overview
17
17
years of professional experience
Work History
Clinical Trials Manager-US
ICON
Blue Bell
11.2022 - 02.2025
- Facilitated oncology trials to advance research on cancer treatments and therapies.
- Supported study activation and maintenance for 35+ U.S. investigative sites.
- Acted as primary liaison among internal departments, CRAs, vendors, CROs, and sponsors to streamline collaboration.
- Prepared and distributed meeting agendas, reports, and follow-up action items for internal teams and study partners, ensuring effective communication.
- Uploaded, maintained and organized study-related documents within clinical trial systems and eTMF platforms.
- Updated internal reference materials and study documentation to support site processes.
- Submitted all sites to Central IRB and local IRBs.
Research Administration Associate/ Regulatory Manager
Baylor College of Medicine
10.2017 - 12.2021
- Facilitated study start-up and activation processes for oncology clinical trials.
- Coordinated cross-functional meetings, documenting action items and tracking progress to ensure timely achievement of project milestones.
- Prepared and maintained study documentation within institutional systems.
- Collaborated with investigators, IRBs, internal departments, and external partners to streamline study access and manage supplies effectively.
- Assisted with reporting and document tracking to support efficient database maintenance for trial activation activities.
- Submitted all sites to central IRB and local IRBs to ensure compliance.
Regulatory Specialist
Baylor College of Medicine
10.2016 - 10.2017
- Coordinated regulatory and activation activities for clinical research studies, ensuring compliance with relevant guidelines.
- Guided investigators and research staff through study activation processes, ensuring all regulatory requirements were met.
- Submitted all sites for IRB approval locally and US wide.
- Managed and updated study documentation in electronic submission and tracking systems, facilitating efficient tracking and retrieval.
- Maintained organized, inspection-ready study files and reference materials.
Regulatory Specialist
McKesson Specialty Health CRO
09.2014 - 10.2016
- Assisted in study start-up activities, including IRB submissions and document coordination to facilitate timely project initiation.
- Monitored study documentation and site requirements to ensure timely trial activation.
- Coordinated communication among investigative sites, CRO teams, and pharmaceutical sponsors to ensure alignment and clarity.
- Oversaw study-specific document uploads across tracking systems to maintain organized and accessible records.
Sr. Regulatory Specialist/Research Coordinator
St. Lukes Episcopal Hospital
04.2012 - 10.2014
- Recruited subjects for multiple research trials, significantly boosting enrollment rates.
- Supported study start-up activities through IRB submissions and document coordination.
- Managed and organized study-specific documents across tracking systems to ensure compliance and accuracy.
- Monitored documentation and site requirements to support timely activation of trials.
- Coordinated communication between sponsor IRB and study team to streamline processes.
Clinical Research Coordinator
University of Texas Health Science Center, Medicine-Oncology
Houston
09.2007 - 03.2012
- Coordinated oncology clinical trials during study start up, managing documentation and site logistics to ensure compliance.
- Facilitated meeting preparation, internal reporting, and communication among research teams to streamline project progress.
- Organized study binders, databases, and activation documentation to support regulatory requirements and study milestones.
Education
Bachelor of Science - Psychology
University of Houston Downtown
Houston, TexasSkills
- Study activation
- Trials operations support
- Trial management
- Site coordination
- Study design
- Clinical trial knowledge
- Regulatory compliance
- Regulatory processes
- Protocol development
- Study document management
- Document management
- Site monitoring
- Site selection
- Stakeholder engagement
- Investigator relations
- Patient management
- Communication strategies
- Cross-functional collaboration
- Meeting facilitation
- Trial oversight
- Audit preparation
- Study records
- Study reports
- Feasibility analysis
- Ethics submissions
- IRB submissions
- Adverse event reporting
- Pharmacovigilance
- GCP training
- Good clinical practice
- Informed consent procedures
- Consent process
- Clinical research ethics
- Problem resolution
- Conflict resolution
- Time prioritization
- Results-oriented
- Detail orientation
- Data analysis
- Decision-making
- Database organization
- Microsoft Office Suite proficiency
- Excel spreadsheet skills
- CTMS knowledge
- eTMF experience
- OnCore familiarity
- REDCap management
- Medidata expertise
- Electronic data capture
- Case report form completion
- Document review
- Document verification
- Study coordination
- Training and mentoring
- Talent acquisition
- Operations management
- Budget management
- Continuous improvement
- Quality assurance
- Analytical skills
- Pharmacovigilance
- Professionalism
- Team leadership
- Customer engagement
- Retention strategies
- Activation metrics tracking
- Product handling
- Research planning
- Research sops understanding
- Trial oversight
- Safety reporting
- Investigation support
- Auditing techniques
- Fluent in english
- Team leadership
- Goal setting
- Continuous improvement
- Goal setting
- Informed consent procedures
- Research sops understanding
- Analytical skills
- Protocol review
- Trial oversight
- Patient management
- Research planning
- Quality assurance
- Decision-making
- Budget management
- Professionalism
Languages
Spanish
Native/ Bilingual
Timeline
Clinical Trials Manager-US
ICON
11.2022 - 02.2025
Research Administration Associate/ Regulatory Manager
Baylor College of Medicine
10.2017 - 12.2021
Regulatory Specialist
Baylor College of Medicine
10.2016 - 10.2017
Regulatory Specialist
McKesson Specialty Health CRO
09.2014 - 10.2016
Sr. Regulatory Specialist/Research Coordinator
St. Lukes Episcopal Hospital
04.2012 - 10.2014
Clinical Research Coordinator
University of Texas Health Science Center, Medicine-Oncology
09.2007 - 03.2012
Bachelor of Science - Psychology
University of Houston Downtown