Heidy Gutiérrez
Barcelona
Summary
Clinical Research Associate with 5 years of experience in clinical research and medical Affairs possessing a strong background in conducting international clinical trials with project experience ranging from conception to development, alongside in-depth knowledge of ICH GCP guidelines. Dedicated Clinical Research Professional with extensive experience in several fields including oncology, CNS, Liver Diseases and cardiovascular disease. Proven track record in early-stage first-in-human studies through late-phase trials. Proficient in on-site trial processes, maintaining ICH-GCP compliance, and ensuring patient safety and data integrity. Successfully managed and initiated numerous trials across top institutions, consistently meeting and surpassing recruitment targets. With a focus on enhancing protocol adherence and streamlining communication, I am passionate about delving deeper into science liaison, project management, pharmacovigilance, and drug interactions, aiming to further connect clinical research with patient care.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Clinical Research Associate II
Icon PLC
Barcelona
12.2021 - Current
- Managed the investigator recruitment process, including conducting site evaluations for potential investigators and assessing the site's capability to successfully conduct the clinical study
- Coordinated actions between site and internal departments to prepare for the clinical study
- Reviewed and ensured informed consent form (ICF) compliance across trial sites to protect patient rights
- Conducted on-site and remote Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), and Close-Out Visits (COVs), ensuring trial quality
- Evaluated and validated source documentations as required
- Verified clinical trial data points onsite for robust interim analysis integrity
- Assessed the quality and integrity of clinical data to successfully resolve data queries and ensure robust data production
- Detection of protocol deviations and implementation of corrective actions
- Maintained 98% accuracy in SAE reporting by rigorously adhering to ICH-GCP guidelines
- Successfully resolved any issues to ensure regulatory compliance
- Provided monitoring reports as per the agreed deadlines
- Improved protocol adherence with IP accountability assessments and corrective actions
- Enhanced communication by updating trial tools and providing weekly team reports.
Clinical Research Coordinator - Phase I Oncology
Hospital de la Santa Creu i Sant Pau
Barcelona
02.2021 - 12.2021
- Coordinated the Phase I Clinical Oncology Research division, overseeing 12 clinical trials with an emphasis on patient safety and data integrity, especially in the early phases of complexity, and increasing the number of successful outcomes
- Management and direct interaction with the different vendors of the study
- Increased compliance with Good Clinical Practice (GCP) and protocol guidelines by 50% through the strategic redesign of training workshops for research staff
- Established and maintained a record-keeping system to ensure proper documentation of each clinical protocol in accordance with FDA requirements
- Liaison between the PI, sponsor, ethics committee, institution and sometimes even with the on-site lab and patients
- Attended investigator meetings as determined by the Director of Research
- Assisted PIs in providing patients and their families with a comprehensive description of the research protocol
- Resolved study queries per month, reducing potential study delays
- Prepared for audits with no major findings, underscoring stellar compliance
- Shipment and management of biological samples.
Clinical Trial Coordinator in Colorectal Cancer
Hospital de la Santa Creu i Sant Pau
Barcelona
09.2019 - 02.2021
- Supervised Phase II-IV CRC trials, meeting 80% of recruitment targets on time
- Maintained 100% compliance with ICH-GCP and local regulations, resulting in zero audit discrepancies
- Exceeded enrollment targets by 10% across all trials
- Assisted with budget and CTA negotiation
- Involvement in the clinical trial start-up process.
Junior Clinical Research Associate and trainee
Hospital de la Santa Creu i Sant Pau
Barcelona
10.2018 - 08.2019
- Strictly adhered to GCP, local laws, and both company and sponsor SOPs
- Verified source documents, achieving a 98% accuracy rate in trial data
- Working in a team with applications to MPA and Ethics Commite and patient informed consent at the start of the clinical trial
- Preparing research study advertisements for submission to the institutional review board (IRB) for approval to aid in subject recruitment
- Ensure that all protocol revisions, informed consents, continuing reviews, serious adverse events are submitted to the appropriate IRB of record in a timely manner
- Research assistant at the phase I unit for clinical trials (clinical development, medical writing, regulatory affairs, QA...).
Education
Master of Science - International Master in Medical Affairs and MSL
IMF Smart Education And University of Avila
Avila09-2023
Master of Science - Clinical Tirals Monitorization And Pharma Industry
Inkemia IUCT
Barcelona, Spain02-2019
Bachelor of Science - Chemistry
University of The Basque Country
Bilbao, Spain03-2018
Bachelor of Science - Erasmus Chemistry
University Degli Study Di Parma
Parma, Italy 01-2017
Skills
- Oncology Drug Mechanisms
- Pharmacovigilance
- Toxicology
- PK/PD Knowledge
- Oncology Clinical Trial Design
- Clinical Data Management
- SAE Management
- Project development and management
- Compliance management
- Clinical research process
- Excellent planning
- Investigator Assessments
- Team working
- Site evaluation
- Communication and mediation
- Critical complex data analyst
- Effective problem-solving skills
- Adaptability to new environments
- Medical Affairs
- Serious Adverse event reporting
- IT systems (eTMF, EDC, IWRS/RTSM PSO, CTMS)
Certification
- Effectiveness of Immunotherapy in Solid Tumors
- ICH-GCPs
- IATA
- ECG reading and interpretation
Timeline
Clinical Research Associate II
Icon PLC
12.2021 - Current
Clinical Research Coordinator - Phase I Oncology
Hospital de la Santa Creu i Sant Pau
02.2021 - 12.2021
Clinical Trial Coordinator in Colorectal Cancer
Hospital de la Santa Creu i Sant Pau
09.2019 - 02.2021
Junior Clinical Research Associate and trainee
Hospital de la Santa Creu i Sant Pau
10.2018 - 08.2019
Master of Science - International Master in Medical Affairs and MSL
IMF Smart Education And University of Avila
Master of Science - Clinical Tirals Monitorization And Pharma Industry
Inkemia IUCT
Bachelor of Science - Chemistry
University of The Basque Country
Bachelor of Science - Erasmus Chemistry
University Degli Study Di Parma
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