Johanna Duran-Lituma
Miami
Summary
Clinical research professional with a strong foundation in managing complex clinical trials while ensuring regulatory compliance and subject safety. Experienced in site operations, including recruitment, enrollment, and data management, with a focus on achieving results and maintaining high standards. Proven ability to collaborate effectively with site teams and drive successful project outcomes.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Senior Clinical Research Associate II
IQVIA
09.2024 - Current
- Conducted site selection, initiation, monitoring, and close-out visits following contracted scope and good clinical practice.
- Supported the development of project subject recruitment plans, collaborating with sites to enhance recruitment predictability.
- Evaluated quality and integrity of study site practices, ensuring proper conduct of protocols and adherence to applicable regulations.
- Managed study progress by tracking regulatory submissions, recruitment, enrollment, case report form (CRF) completion, and data query resolution.
- Created and maintained documentation regarding site management, monitoring visit findings, and action plans.
Senior Clinical Research Associate I
IQVIA
05.2023 - 09.2024
- Performed site selection, initiation, monitoring, and close-out visits in accordance with good clinical practice.
- Supported site-specific subject recruitment plans, working to track and adapt plans according to project needs.
- Administered protocol training to sites and maintained communication to manage project expectations and issues.
- Evaluated site practices for protocol adherence and escalated quality issues as necessary.
- Monitored progress of assigned studies and generated required study documentation.
Clinical Research Associate II
IQVIA
02.2022 - 04.2023
- Conducted site selection, initiation, monitoring, and close-out visits following contracted scope and good clinical practice.
- Supported site-specific subject recruitment plans, working closely with sites to enhance recruitment efforts.
- Administered training on protocols to assigned sites and maintained effective communication for ongoing project management.
- Evaluated quality and integrity of study site practices and escalated issues as necessary.
- Maintained comprehensive documentation regarding site management and monitoring visit findings.
Clinical Research Associate I
IQVIA
04.2021 - 02.2022
- Conducted site selection, initiation, monitoring, and close-out visits in accordance with good clinical practice.
- Assisted with site-specific subject recruitment plans, adapting them to enhance recruitment predictability.
- Provided protocol training to sites and communicated regularly to manage project expectations.
- Evaluated site practices for adherence to protocols and escalated quality issues as necessary.
- Managed the progress of assigned studies and maintained accurate site documentation.
Medical Office, Assistant Manager
Union Square Medical Associates, PC
01.2017 - 04.2021
- Educated patients and families on health management and community resources by creating care plans.
- Leveraged patient feedback to improve business operations and patient satisfaction.
- Maintained accountability for patient services by applying strategic planning and project management skills.
Clinical Research Manager
USMA Clinical Research, LLC
05.2015 - 04.2021
- Managed phase III and IV trials across multiple therapeutic areas in compliance with SOPs and protocols.
- Assisted investigators and sponsors in achieving key study parameters, including study execution and data collection.
- Maintained regulatory, clinical, and administrative documentation in compliance with protocols and amendments.
- Prepared source documentation and dosing instructions for Investigational Product activities per protocols.
- Monitored contracts and budgets to meet financial objectives and ensured compliance with FDA audits.
Education
Bachelor of Science - Biology
Kean University
United States05-2013
Skills
- Clinical trial management
- Patient safety monitoring
- Informed consent process
- Site management
- Good clinical practices
- Patient enrollment and retention
- Subject recruitment
- Data management proficiency
- Adverse event reporting
- Monitoring visits
- ICH-GCP guidelines
- Site operations coordination
Certification
- DOT and IATA Certification, 2021
- CPR, AED and Basic First Aid Certification, 2021
- Use and Administration of Epinephrine Auto-Injector Certification, 2021
- IQVIA Fundamentals GCP Exam for support staff. Completed: 04 AUG, 2022
- Global Oncology Fundamentals for Monitors, 2024
Language(s)
English: Speaking - Fluent, Reading - Fluent, Writing - Fluent
Spanish-Castilian: Speaking - Fluent, Reading - Fluent, Writing - Fluent
Portuguese: Speaking - Basic, Reading - Basic, Writing - Basic
Clinical Trial Experience
- IQVIA and its Affiliated Companies Clinical Trial Experience
- Study Phase: Phase 3, Indication: RSV, Role: Clinical Research Associate, Key Responsibilities: Full scope of Unblinded Clinical Research Associate responsibilities
- Study Phase: Phase 3, Indication: COVID-19, Role: Clinical Research Associate II, Key Responsibilities: Full scope of Blinded Clinical Research Associate respons
- Study Phase: Phase 2, Indication: Influenza A (H1N1), Role: Clinical Research Associate II, Key Responsibilities: Full scope of Blinded Clinical Research Associate responsibilities
- Study Phase: Phase 2, Indication: COVID-19, Special Population: Immunocompromised Patients, Drug Class: Biologic (Antibody), # of Patients: 450, Role: Senior Clinical Research Associate, Key Responsibilities: Full scope of Clinical Research Associate responsibilities
- Study Phase: Phase 3, Indication: COVID-19, Special Population: Immunocompromised Patients, Drug Class: Biologic (Antibody), # of Patients: 3200, Role: Senior Clinical Research Associate, Key Responsibilities: Full scope of Blinded Clinical Research Associate responsibilities
- Study Phase: Phase 3, Indication: Influenza, Special Population: Elderly, Drug Class: Vaccines - Antiviral, # of Patients: 7700, Role: Senior Clinical Research Associate, Key Responsibilities: Full scope of Blinded Clinical Research Associate responsibilities
- Study Phase: Phase 3, Indication: COVID-19, Special Population: Elderly, Drug Class: Biologic (Antibody Drug Conjugate (ADC)), # of Patients: 2509, Role: Senior Clinical Research Associate, Key Responsibilities: Full scope of Blinded Clinical Research Associate responsibilities
- Study Phase: Phase 3, Indication: RSV, Special Population: Elderly, Drug Class: Vaccines - Antiviral, # of Countries: 14, # of Sites: 345, # of Patients: 29000, Role: Senior Clinical Research Associate, Key Responsibilities: Full scope of Blinded Clinical Research Associate responsibilities
- Study Phase: Phase 3, Indication: RSV, Special Population: Elderly, Drug Class: Vaccines - Antiviral, # of Countries: 1, # of Patients: 1720, Role: Senior Clinical Research Associate, Key Responsibilities: Full scope of Blinded Clinical Research Associate responsibilities
- Study Phase: Phase 3, Indication: Influenza, Special Population: Elderly, Drug Class: Vaccines - Antiviral, # of Countries: 17, # of Patients: 49000, Role: Senior CRA 2, Key Responsibilities: Full scope of Blinded Clinical Research Associate responsibilities
- Study Phase: Phase 3, Indication: Hepatic failure, # of Patients: 800, Role: Senior CRA 2, Key Responsibilities: Full scope of Blinded Clinical Research Associate responsibilities
- Study Phase: Phase 3, Indication: Focal glomerular sclerosis, # of Sites: 185, # of Patients: 286, Role: Senior CRA 2, Key Responsibilities: Full scope of Blinded Clinical Research Associate responsibilities
Timeline
Senior Clinical Research Associate II
IQVIA
09.2024 - Current
Senior Clinical Research Associate I
IQVIA
05.2023 - 09.2024
Clinical Research Associate II
IQVIA
02.2022 - 04.2023
Clinical Research Associate I
IQVIA
04.2021 - 02.2022
Medical Office, Assistant Manager
Union Square Medical Associates, PC
01.2017 - 04.2021
Clinical Research Manager
USMA Clinical Research, LLC
05.2015 - 04.2021
Bachelor of Science - Biology
Kean University