Catiana Augusme
Maryland,USA
Summary
Dedicated clinical research professional with extensive experience in coordinating clinical studies from start-up to close-out while ensuring compliance with ICH-GCP and local regulations. Proficient in clinical trial oversight with a focus in Quality & Risk management. Adept at document collection, tracking, and timely submissions to Ethics Committees, Institutional Review Boards and regulatory authorities. Proven skills in managing electronic Trial Master Files (eTMF) and Investigational Site Files (ISF) for inspection readiness. Committed to delivering robust project outcomes while fostering effective relationships with clients and external partners.
Overview
3
3
years of professional experience
Work History
Quality Assurance Specialist II
Precision for Medicine
Frederick, USA
06.2024 - Current
- Company Overview: Global CRO
- Provide hands-on support in GxP laboratory services, maintaining quality systems and managing assigned activities
- Manage all minor, major and critical non-conformance events
- Collaborate with project management to ensure compliance with quality deliverables and facilitate regulatory audits
- Conduct internal inspections monthly
- Support GxP quality systems in a laboratory environment by managing non-conformances, customer complaints, CAPA, supplier quality management, and ensuring compliance through internal and supplier audits
- Responsibilities include monitoring equipment calibration, generating Certificates of Analysis and product labels, maintaining quality documentation, leading validation activities, and collaborating with Project Management for quality deliverables
- Conduct process observations, and mentoring staff on industry best practices while maintaining metrics for quality performance
- Global CRO
Quality Specialist I
PAREXEL
Maryland, USA
02.2023 - 06.2024
- Company Overview: Global CRO
- Collaborated with cross-functional teams to address reported quality issues by COLs, PMs and CRAs using Trackwise, Veeva vault clinical
- Managed all minor, major and critical quality issues as quality rep
- Ensured compliance and maintaining inspection readiness by providing oversight and support throughout projects, conducting remote quality evaluations, and facilitating corrective actions for identified risks
- Managed quality metrics, supported TMF internal/ external audits and inspections, and contributed to the development of internal SOPs and process improvements, ultimately enhancing operational efficiency and quality assurance in clinical trials
- Managed quality issues and CAPA processes within clinical trials, ensuring compliance with regulatory guidelines
- Conducted quality evaluations and supported project teams in internal and external audits
- Global CRO
Quality Assurance Specialist I
Velocity Clinical Research
Rockville, USA
12.2021 - 02.2023
- Company Overview: Global clinical research coordinated study activities across multiple sites, ensuring adherence to protocols through effective training and monitoring practices.
- Coordinated study activities across multiple sites, ensuring adherence to protocols through effective training and monitoring practices
- Implemented corrective action plans and tracked recruitment and data management activities
- Conducted eTMF internal audits ---reviewing ISF document
- Managed the lifecycle of multiple clinical trials from start-up to close-out, ensuring compliance with protocols, Good Clinical Practices (GCP), and regulatory requirements
- Conducted regulatory audits, trained site staff, and developed corrective action plans to address site deviations
- Provided consultation during Sponsor and FDA audits, managed data accuracy in case report forms, and verified informed consent processes
- Collaborated with Principal Investigators, CRAs, CRCs project teams, and clinical staff to manage all site studies
- Conducted risk-based monitoring, and facilitated training to enhance employee proficiency and operational efficiency in clinical study conduct
Education
Bachelor’s of Arts in - Social Science
University of North Florida
Jacksonville, FLSkills
- Project Management
- Drug Accountability
- Data Entry and Analysis
- Multitasking and Prioritization
- Quality & Risk Management
- eTMF audits and inspections
- Phase I-IV Clinical Trial monitoring
- Regulatory inspections
- SAE Management
- Source Documentation Evaluation
- Microsoft Suite
- Protocol management
- Data management
- Clinical Data Management System oversight:EDCs RAVE, IMednet, Medidata-CTMS/eTMF, Veeva Clinical Vault, IRT/IWRS systems, Suvoda, Calyx, PPD IRT
Affiliations
- American Sociological Association
- American Evaluation Association
- Association of Clinical Research Professionals
Accomplishments
- Skilled in protocol management.
- Proficiency in data management and organizing data collected during the study, maintaining accurate records, and ensuring data integrity and confidentiality.
- Clinical Data Management System Expert: adept with EDCs RAVE, IMednet, Medidata, CTMS/eTMF Veeva Clinical Vault, and IRT/IWRS systems Suvoda, Calyx, PPD IRT.
- Conducting TMF audits/ regulatory inspections.
- Excellent organizational and time management skills; strong attention to detail.
- Proficient in oversight with clinical trial management systems and related technology (e.g., Veeva, CTMS).
- Adept at coordination and administration of clinical studies from the start-up to execution and close-out.
- Strong verbal and written communication abilities; capable of training and supporting team members.
- Demonstrated integrity, high ethical standards, and a commitment to compliance with regulatory requirements.
- Proficient in Clinical trial monitoring and oversight in global trials.
Timeline
Quality Assurance Specialist II
Precision for Medicine
06.2024 - Current
Quality Specialist I
PAREXEL
02.2023 - 06.2024
Quality Assurance Specialist I
Velocity Clinical Research
12.2021 - 02.2023
Bachelor’s of Arts in - Social Science
University of North Florida
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