Santamarina kretowicz
Clinical Research Associate
Buenos Aires,C
Summary
Clinical Research Associate with over 3 years of experience managing Phase II-III clinical trials in diverse therapeutic areas, including oncology, cardiovascular, respiratory, and dermatology. Proven skills in site management, regulatory compliance, and data quality assurance. Experienced in building strong relationships with investigators and site personnel to ensure successful study outcomes.
Work History
Clinical Research Associate Level II
KPS Life
Buenos Aires, Buenos Aires F.D.
2024.03 - Current
- Managed trials in therapeutic areas: Metastatic Breast Cancer (Phase III), Plaque Psoriasis (Phase III), and Chronic Sinusitis Without Nasal Polyps (Phase II)
- Conducted SIV, IMV, and COV visits ensuring compliance with protocols, GCP, and regulations
- Resolved site issues and implemented strategies to optimize performance, boosting compliance and metrics
- Delivered detailed monitoring reports adhering to SOPs and GCP guidelines
- Responsible for ensuring study investigators and coordinators comply with the study protocol, GCPs, CFRs, and IRB/EC requirements through training and guidance
- Conducted periodic on-site evaluations and follow-up of corrective actions
Clinical Research Associate Level II
Fortrea
Buenos Aires, Buenos Aires F.D.
2023.07 - 2024.03
- Managed trials in therapeutic areas: Macular Degeneration (Phase III), Chronic Obstructive Pulmonary Disease (COPD) (Phase III), Gastrointestinal Cancer (Phase IIa), Cardiovascular Disease (Phase III), and Asthma (Phase II)
- Verified source data, resolved queries, and ensured document accuracy
- Trained junior team members, enhancing efficiency and adherence to protocols
- Monitored site activities to ensure protocol compliance and data quality
- Acted as the primary liaison to clinical sites
- Conducted site qualification visits, essential document collection during study start-up, site initiation visits and training, monitoring visits, and site close-out visits fore more than 20 sites.
Clinical Research Associate I
ICON Strategic Solutions
Buenos Aires, Buenos Aires F.D.
2022.05 - 2023.05
- Managed Phase II trials in Asthma and Sjögren's Syndrome
- Ensured regulatory document compliance and conducted risk assessments to address challenges
- Improved trial efficiency through optimized recruitment strategies
- Generated high-quality reports for qualification, initiation, monitoring, and close-out visits in accordance with the Clinical Monitoring Plan
Clinical Research Associate
PRA Health Sciences
Buenos Aires, Buenos Aires F.D.
2021.11 - 2022.05
- Conducted Pre selection visits and prepared data strategies for SIVs, enhancing readiness and operations.
- Completed ICON CRA Academy training, mastering regulatory compliance and communication strategies.
- Managed approximately 30 incoming calls, emails and faxes per day from customers.
Education
Bachelor of Science - Molecular Biology
2015.06 - 2025.06
Skills
Medidata Rave
Veeva EDC
Oracle Clinical
ClinTrial
Impact
Siebel CTMS
Veeva Vault CTMS
Medidata CTMS
Xcellerate
Endpoint
Cenduit
Almac
Certification
GCP Certification - ICON's Firecrest GCP Training
Timeline
Clinical Research Associate Level II - KPS Life
2024.03 - Current
Clinical Research Associate Level II - Fortrea
2023.07 - 2024.03
Clinical Research Associate I - ICON Strategic Solutions
2022.05 - 2023.05
Clinical Research Associate - PRA Health Sciences
2021.11 - 2022.05
University of Buenos Aires - Bachelor of Science, Molecular Biology
2015.06 - 2025.06