Norma Reyes Leggio
Clinical Research Professional
HOUSTON,TX
Summary
Highly dependable, resourceful and well- organized research professional experienced in Phases I-III oncology trials who uses perseverance and determination to drive individual and team success towards meeting project goals.
Overview
12
12
years of professional experience
Work History
Clinical Trial Manager
IQVIA Biotech
12.2022 - Current
- Enhanced patient safety by meticulously monitoring clinical trial activities and promptly addressing any issues.
- Streamlined trial management processes for increased efficiency through diligent organization and coordination of resources.
- Managed cross-functional teams to ensure timely completion of clinical trial milestones and deliverables.
- Ensured compliance with regulatory guidelines by thoroughly reviewing protocols, informed consent forms, and other essential documents.
- Achieved successful recruitment targets by implementing strategic patient enrollment plans and collaborating with study sites.
- Mitigated risks in the clinical trial process by proactively identifying potential issues and implementing corrective actions.
- Improved data quality in clinical trials by overseeing data management activities such as data cleaning, validation, and database lock procedures.
- Contributed to protocol development, ensuring a well-designed study that met research objectives while adhering to ethical standards and regulations.
- Spearheaded the selection of appropriate clinical sites by conducting thorough feasibility assessments based on predefined criteria.
- Monitored unit budget to meet financial objectives for spend rate and funding.
Clinical Trial Manager
ICON Clinical Research
08.2021 - 11.2022
- Enhanced patient safety by meticulously monitoring clinical trial activities and promptly addressing any issues.
- Streamlined trial management processes for increased efficiency through diligent organization and coordination of resources.
- Facilitated clear communication between study teams, sponsors, and investigators to maintain alignment on project goals and expectations.
- Mitigated risks in the clinical trial process by proactively identifying potential issues and implementing corrective actions.
- Improved data quality in clinical trials by overseeing data management activities such as data cleaning, validation, and database lock procedures.
- Collaborated closely with biostatisticians for accurate statistical analysis planning in support of study objectives.
- Fostered strong relationships with investigative sites, leading to increased collaboration and improved study outcomes.
- Implemented risk management strategies, effectively minimizing potential threats to the success of clinical trials.
- Monitored unit budget to meet financial objectives for spend rate and funding.
Senior Clinical Research Associate
ICON Clinical Research
10.2020 - 08.2021
- Enhanced patient safety through meticulous monitoring of adverse events and protocol compliance.
- Developed strong relationships with investigators and site staff, fostering a culture of trust and open communication throughout the study duration.
- Ensured timely completion of monitoring visits, enabling consistent oversight of site performance and adherence to Good Clinical Practice guidelines.
- Mitigated risks to subject safety or study integrity by promptly identifying issues during site visits and implementing corrective actions as necessary.
- Demonstrated thorough knowledge of regulatory requirements in all aspects of clinical trial conduct, promoting compliance within assigned projects.
- Conducted initiation and monitoring visits to verify study procedures, regulatory documents and data completion.
- Participated in initiation visits and implemented trials in accordance with study timelines and budgets.
- Maintained compliance with protocols covering patient care and clinical trial operations.
Senior Clinical Research Associate
Syneos
04.2019 - 10.2020
- Enhanced patient safety through meticulous monitoring of adverse events and protocol compliance.
- Improved clinical trial efficiency by streamlining data collection and management processes.
- Developed strong relationships with investigators and site staff, fostering a culture of trust and open communication throughout the study duration.
- Ensured timely completion of monitoring visits, enabling consistent oversight of site performance and adherence to Good Clinical Practice guidelines.
- Mitigated risks to subject safety or study integrity by promptly identifying issues during site visits and implementing corrective actions as necessary.
- Facilitated seamless transitions between study phases through proactive planning, coordination, and communication with internal stakeholders.
- Demonstrated thorough knowledge of regulatory requirements in all aspects of clinical trial conduct, promoting compliance within assigned projects.
- Provided expert guidance to junior team members, fostering a culture of continuous learning and professional growth.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Managed project risk by identifying, quantifying and monitoring potential threats.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Clinical Research Associate II
ICON Clinical Research
02.2018 - 04.2019
- Improved patient enrollment by developing and implementing effective recruitment strategies.
- Enhanced data quality by closely monitoring study progress and ensuring accurate data collection.
- Streamlined clinical trial processes for increased efficiency, utilizing strong organizational skills.
- Collaborated with cross-functional teams to successfully meet project timelines and deliverables.
- Ensured protocol adherence, conducting regular site visits and providing training to study staff as needed.
- Facilitated timely resolution of issues through effective communication with investigators, sponsors, and other stakeholders.
- Developed strong relationships with investigators and site personnel to ensure ongoing compliance with study requirements.
- Maintained comprehensive knowledge of applicable regulations and guidelines, ensuring full compliance throughout all stages of clinical trials.
- Assessed safety reporting requirements for each study, ensuring proper documentation and notification procedures were followed consistently.
- Supported the successful completion of clinical trials by proactively managing risks and addressing challenges throughout all stages of the study process.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Conducted monitoring visits to verify study procedures, regulatory documents and data completion.
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
- Reviewed data queries and listings and worked with study centers to resolve data discrepancies.
- Traveled to investigative sites to conduct site interim monitoring visits to maintain and enforce regulatory compliance.
- Submitted routine [Type] reports and follow-up letters to facilitate internal and external communication.
- Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
- Mentored team members by sharing knowledge, experience, lessons-learned to perform successful monitoring visits.
- Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
- Leveraged nursing and oncology knowledge, expertise and problem-solving techniques to resolve investigative site issues.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Clinical Research Associate I and II
PRA Health Sciences
09.2015 - 02.2018
Senior Clinical Research Coordinator
Texas Oncology Deke Slayton Cancer Center
11.2014 - 07.2015
- Improved patient recruitment by developing and implementing targeted outreach strategies.
- Enhanced data quality by closely monitoring study metrics and resolving discrepancies in a timely manner.
- Streamlined study processes for increased efficiency by collaborating with cross-functional teams on study requirements and implementation.
- Ensured compliance with regulatory requirements by conducting thorough audits of study documents and procedures.
- Reduced protocol deviations by providing comprehensive training and support to research staff.
- Served as a liaison between site personnel, investigators, and sponsors to ensure clear communication throughout the trial process.
- Facilitated clinical trial progression, effectively managing multiple projects simultaneously.
- Fostered a positive working environment for research staff through regular team-building activities and ongoing professional development opportunities.
- Optimized patient safety during clinical trials by diligently monitoring adverse events and promptly escalating concerns when necessary.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Followed informed consent processes and maintained records.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Clinical Research Nurse
University Of Texas MD Anderson Cancer Center
05.2013 - 11.2014
- Streamlined the data collection process for improved accuracy and efficiency in clinical trial documentation.
- Assisted in obtaining informed consent from patients, ensuring ethical and legal compliance throughout the study.
- Developed strong relationships with patients and families, providing support and education regarding their participation in clinical trials.
- Maintained detailed records of adverse events, facilitating timely reporting to regulatory agencies and sponsors.
- Supported Principal Investigators by coordinating day-to-day activities of clinical research projects, ensuring smooth operations.
- Provided expert nursing care to research participants, adhering to protocol requirements while prioritizing patient wellbeing.
- Evaluated the effectiveness of interventions used in clinical trials by analyzing study outcomes and presenting findings at professional conferences.
- Monitored patients'' vital signs during study visits, ensuring prompt intervention as needed based on established criteria.
- Coordinated with laboratory personnel for efficient processing of biological samples collected during research studies.
- Reviewed study protocols regularly for compliance with federal regulations, institutional policies, and good clinical practice guidelines.
- Facilitated cross-functional teamwork within the research department by collaborating closely with various healthcare professionals.
- Ensured accurate and timely completion of study documentation, maintaining consistency across all sites and minimizing data discrepancies.
- Evaluated patient histories, complaints, and current symptoms.
- Collaborated with interdisciplinary teams to develop and execute high-quality clinical research studies.
- Improved patient recruitment strategies, resulting in increased participation in clinical trials.
Community Health Nurse Supervisor
Southern Nevada Health District
07.2010 - 12.2012
- Enhanced community health through delivery of programs for women's health, teen pregnancy prevention and pediatric and adult immunization for disease prevention and healthy lifestyles.
- Provided leadership and oversight for approximately 25 staff across three clinic sites in Southern Nevada.
- Collaborated with cross functional teams to develop effective interventions for successful delivery of public health programs across three clinics in Henderson, North Las Vegas and Indian Springs, Nevada.
Clinical Research Coordinator II
Comprehensive Cancer Centers Of Nevada
09.2008 - 07.2010
- Enhanced patient safety by meticulously monitoring and documenting adverse events during clinical trials.
- Coordinated with cross-functional teams to ensure timely completion of clinical trial milestones.
- Improved recruitment rates by developing and implementing effective patient outreach strategies.
- Maintained compliance with regulatory guidelines through rigorous documentation and protocol adherence.
- Facilitated clear communication between principal investigators, sponsors, and study participants for seamless trial execution.
- Trained new team members on essential clinical research protocols and procedures, promoting a culture of continuous learning.
- Oversaw the management of investigational product supplies, ensuring appropriate storage conditions were maintained at all times for optimal efficacy during trials.
- Assessed patients'' eligibility criteria following strict adherence to inclusion/exclusion guidelines.
- Contributed to the successful completion of clinical trials by proactively resolving issues, mitigating risks, and meeting deadlines in a fast-paced environment.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
Education
Master of Science - Public Health
University of Nevada - Las Vegas
Las Vegas, NV12.2009
Bachelor of Science - Nursing
University of Nevada - Las Vegas
Las Vegas, NV05.1995
Associate of Science - General Studies
Community College of Southern Nevada
Las Vegas, NV07.1991
Skills
- Results-Oriented
- Training and Mentoring
- Site Selection
- Problem Solving
- Interpersonal Skills
- Adaptability
- Attention to Detail
- Risk Assessment
- Quality Assurance
- GCP Knowledge
- Multitasking
- Investigator Relations
- Resource Allocation
- Process Improvement
- Clinical Trial Oversight
- Organizational Skills
- Cross-functional Collaboration
- Team Leadership
- Performance Metrics
- Site Monitoring
- Study Coordination
- Research Experience
- Protocol Review
- Informed Consent
- Good Clinical Practices
Accomplishments
- Successive promotions from CRA, CRAII, Senior CRA and Clinical Trial Manager over 6 years.
- Bronze award received for Performance metrics at PRA Health Sciences.
- Research department award for enrollments at Texas Oncology Deke Slayton Cancer Center in 2015.
- Highest Enrollment award at University of Texas MD Anderson Cancer Center in 2014.
Timeline
Clinical Trial Manager
IQVIA Biotech
12.2022 - Current
Clinical Trial Manager
ICON Clinical Research
08.2021 - 11.2022
Senior Clinical Research Associate
ICON Clinical Research
10.2020 - 08.2021
Senior Clinical Research Associate
Syneos
04.2019 - 10.2020
Clinical Research Associate II
ICON Clinical Research
02.2018 - 04.2019
Clinical Research Associate I and II
PRA Health Sciences
09.2015 - 02.2018
Senior Clinical Research Coordinator
Texas Oncology Deke Slayton Cancer Center
11.2014 - 07.2015
Clinical Research Nurse
University Of Texas MD Anderson Cancer Center
05.2013 - 11.2014
Community Health Nurse Supervisor
Southern Nevada Health District
07.2010 - 12.2012
Clinical Research Coordinator II
Comprehensive Cancer Centers Of Nevada
09.2008 - 07.2010
Master of Science - Public Health
University of Nevada - Las Vegas
Bachelor of Science - Nursing
University of Nevada - Las Vegas
Associate of Science - General Studies
Community College of Southern Nevada
Similar Profiles
Adrian Palacios MendezAdrian Palacios Mendez
Associate Director, Global Template Development at IQVIA BiotechAssociate Director, Global Template Development at IQVIA Biotech
Andrea TillerAndrea Tiller
Director, Head of Database Design at IQVIA BiotechDirector, Head of Database Design at IQVIA Biotech
Katherine BanuelosKatherine Banuelos
Field Inventory Managment at IQVIA BiotechField Inventory Managment at IQVIA Biotech
America Vega Y RojoAmerica Vega Y Rojo
Sr. Clinical Trial Manager at IQVIA BiotechSr. Clinical Trial Manager at IQVIA Biotech
Teia AllenTeia Allen
Senior Client Relations Specialist at Veterans Affairs Medical Center (Prosthetics)Senior Client Relations Specialist at Veterans Affairs Medical Center (Prosthetics)