Larrissa Otero
Coconut Creek,FL
Summary
Detail-oriented research professional with extensive experience in clinical trials, regulatory affairs and compliance. Expert in identifying and mitigating potential risks while maintaining rigorous adherence to legal and regulatory standards. Proficient in conducting comprehensive compliance audits, overseeing monitoring activities, and designing effective compliance programs. Demonstrated ability to foster collaborative team efforts, consistently delivering measurable results. Recognized for reliability, adaptability, and strategic problem-solving skills.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Research Monitoring & Compliance Officer
Memorial Healthcare System
09.2023 - Current
- Lead compliance and education specialists, providing guidance, support, and training in research compliance
- Revise Standard Operating Procedures (SOPs) for the Office of Human Research (OHR) and create instructional manuals
- Perform audit checks via risk-based assessments to ensure protocol adherence and compliance with FDA CFR, study-specific, and departmental SOPs, and ICH GCP
- Monitor clinical trials across 6 hospitals, supporting investigators and site personnel with all research compliance and reporting issues, including CAPA plans
- Design, conduct, and implement company QA/QC standards to improve research outcomes and regulatory compliance
- Liaise with external monitors to ensure all findings and scope of work are completed within appropriate timelines and budget constraints
- Ensure NCI registrations for all oncology investigators are renewed and kept current
- Prepare clinical, regulatory, and pharmacy teams for internal and external monitoring and audits
- Educate physicians, research nurses, regulatory staff, and new hires on best practices and compliance
- Create marketing materials to promote research at the institution and in the community, elevating the research experience for subjects
Research Compliance & Education Specialist
Memorial Healthcare System
09.2021 - 09.2023
- Scheduled, coordinated, and conducted protocol/project-specific audits for allegations of research non-compliance, high risk, high enrollment, or randomly selected investigator protocols, including monitoring for investigator-initiated trials and preparing for external audits
- Performed comprehensive source data verification of all clinical trial-related documentation, including investigator qualifications, staff training, Electronic Medical Records, and research source documentation, issuing queries as needed to ensure adherence to SOPs and regulatory requirements
- Developed and completed detailed monitoring reports, effectively communicating results to OHR department leadership and research teams, including Principal Investigators
- Managed post-monitoring activities, ensuring timely follow-up on necessary corrective and preventive actions; escalated unacceptable findings to OHR leadership as needed
- Played a key role in the preparation and training of investigators, residents, fellows, new research staff, and pharmacist educational programs
- Assisted Research Specialists with the accurate filing of Protocol Deviations and Serious Adverse Event reporting
- Ensured the completeness and accuracy of all newly completed ICFs in compliance with GDP standards
Clinical Research Associate (Remote)
Quintiles
07.2013 - 12.2013
- Conducted site selection, initiation, monitoring, and close-out visits in compliance with GCP
- Managed monitoring visits and site management activities for diverse protocols and therapeutic areas, ensuring regulatory compliance
- Delivered protocol and study-related training to assigned sites, maintaining regular communication to manage project expectations
- Evaluated site practices for protocol adherence and escalated issues to maintain study integrity
- Tracked regulatory submissions, recruitment, enrollment, and data query resolutions
- Maintained thorough site management records and monitoring visit documentation
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
Research Coordinator II
Pediatrix Medical Group/MEDNAX, Inc.
03.2011 - 06.2013
- Led the coordination and administration of multiple large-scale multi-center clinical trials in Neonatology from inception to completion, ensuring seamless execution
- Directed regulatory activities for over 70 sites, ensuring stringent compliance with ICH Good Clinical Practice Guidelines, HIPAA, FDA, and federal regulations
- Engineered the design of protocols, informed consent forms, manuals of operations, surveys, forms, site monitoring tools, training materials, and tracking tools used by research teams, research coordinators, and CRAs
- Wrote and/or revised Standard Operating Procedures (SOPs)
- Managed the administration of EDC systems, coordinating the collaborative effort between IT departments and research teams for the production, testing, training, and implementation of the systems
- Oversaw data management processes including access level management, query resolution, and quality assurance to ensure accurate and secure data handling
- Developed and maintained comprehensive databases for clinical trials, providing high-quality data management solutions that facilitated efficient data entry, monitoring, and reporting
- Implemented robust data validation and cleaning protocols, ensuring data integrity and accuracy throughout the clinical trial process
- Conducted thorough data analysis and prepared detailed reports to support regulatory submissions and compliance
- Served as the principal liaison with directors of operations, monitors, principal investigators, study coordinators, IRBs, and legal teams
- Coordinated the negotiation and completion of multiple site agreements with hospital administration, legal departments, and site representatives
Senior Regulatory Analyst
University of Miami, Sylvester Comprehensive Cancer Center
06.2010 - 03.2011
- Held responsibility for regulatory activities for over 40 pharmaceutical and cooperative clinical trials in Oncology
- Coordinated the preparation of regulatory documentation for submission to the University of Miami Institutional Review Board (IRB), other University committees, and the FDA, including Initial Submissions, Continuing Reports, Amendments, Adverse Event and Serious Adverse Events reporting, and protocol deviations
- Prepared routine protocol status reports for the CRS office, Investigators, and research staff
- Followed processes and requirements for protocol development and the conduct of research trials
Clinical Research Coordinator
Aptium Oncology/Lynn Cancer Institute
07.2007 - 04.2010
- Coordinated oncology clinical trials with major pharmaceutical companies, maintaining communication with key research partners
- Screened, recruited, and consented subjects, and collected data for electronic case report forms
- Monitored studies for compliance with Good Clinical Practice (GCP)
- Maintained patient contact to track follow-up visits and record adverse events
- Managed drug accountability and specimen shipment, ensuring safety and regulatory adherence
- Held regulatory responsibilities for 50 clinical trials, utilizing a strong regulatory background and knowledge of local and federal regulations
Education
Foreign-Educated Psychologist -
Universidade Catolica De Santos
Santos, SP, Brazil01.1995
Bachelor's - Psychology
Universidade Catolica De Santos
Santos, SP, Brazil01.1994
Skills
- Phase I-IV clinical trials
- Oncology
- FDA and GCP guidelines
- Compliance reviews and monitoring
- Standard operating procedures (SOP)
- Corrective and Preventive Action (CAPA)
- Managing cross-functional teams
- Fostering relationships with stakeholders
- Inspection readiness training
- Microsoft Office and virtual meeting software
- Electronic Trial Master Files
- Clinical Trial Management Systems (CTMS)
- Electronic Data Capture systems (EDCs)
- Audit management (internal and external)
- Quality Assurance (QA) / Quality Control (QC)
Accomplishments
- Successfully managed and coordinated cross-functional teams to prepare for three federal audits, achieving excellent results, demonstrating meticulous attention to detail and thorough knowledge of regulatory requirements and study specifics.
- Received the prestigious "Memorial Excellence Award" for outstanding performance as a compliance auditor, highlighting exceptional commitment to maintaining the highest standards of compliance and integrity.
- Identified and mitigated potential risks through proactive monitoring and risk assessment, resulting in a decrease in findings as shown by metrics, ensuring ongoing compliance with evolving standards.
Certification
- CITI Certified – Biomedical Research, GCP, HIPAA, Financial Conflicts of Interest (2024)
- Lean Six Sigma Yellow Belt Certification (2022)
- SOCRA - Certified Clinical Research Professional - CCRP- 2013
Languages
Portuguese
Native or Bilingual
Spanish
Native or Bilingual
Timeline
Research Monitoring & Compliance Officer
Memorial Healthcare System
09.2023 - Current
Research Compliance & Education Specialist
Memorial Healthcare System
09.2021 - 09.2023
Clinical Research Associate (Remote)
Quintiles
07.2013 - 12.2013
Research Coordinator II
Pediatrix Medical Group/MEDNAX, Inc.
03.2011 - 06.2013
Senior Regulatory Analyst
University of Miami, Sylvester Comprehensive Cancer Center
06.2010 - 03.2011
Clinical Research Coordinator
Aptium Oncology/Lynn Cancer Institute
07.2007 - 04.2010
Foreign-Educated Psychologist -
Universidade Catolica De Santos
Bachelor's - Psychology
Universidade Catolica De Santos
Similar Profiles
Christopher RodriguezChristopher Rodriguez
Administrative Assistant at Memorial Healthcare SystemAdministrative Assistant at Memorial Healthcare System
Kylee MaestreyKylee Maestrey
Registered Nurse at Memorial Healthcare SystemRegistered Nurse at Memorial Healthcare System
KADRA ADDERLYKADRA ADDERLY
IT Project Manager at Memorial Healthcare SystemIT Project Manager at Memorial Healthcare System