LAURA RUEDA ROJAS
Bogotá,DC
Summary
With over 15 years of dedicated experience in the field of clinical research and medical health. My journey in this dynamic industry has seen me evolve from a Clinical Research Associate (CRA) of hands-on experience into an administrative role as a Management Assistant overseeing operations in Latin America. This career trajectory has provided me with a holistic understanding of the clinical research landscape. Clinical Research Therapeutic Areas include: Oncology: Philadelphia chromosome – positive chronic myeloid leukemia (Ph+ CML). Respiratory: Chronic obstructive pulmonary disease – COPD, Asthma. Rheumatology: Rheumatoid Arthritis and Sjögren syndrome Dermatology: Psoriasis. Cardiovascular: Cardiovascular Events. Vaccines: Respiratory Syncytial Virus Rare diseases: Lennox-Gastaut syndrome (epilepsy)
Overview
15
15
years of professional experience
Work History
Sr. CRA II
ThermoFisher/PPD
05.2024 - Current
- Streamlined trial organization and strengthened communication among team members, investigators, and clients to enhance clinical operations.
- Performs and coordinates all aspects of the clinical monitoring and site management process.
- Conducts on-site and remote visits to assess protocol and regulatory compliance and manage required documentation.
- Ensures audit readiness.
- Identified and resolved issues related to protocol deviations, data discrepancies, and regulatory compliance to maintain trial integrity.
- Proactively identifying potential risks and implementing mitigation strategies.
- Assist Clinical trial managers or Project Managers on assigned projects with study metrics and compliance.
- Support in the mentoring and training of junior clinical team members.
Management Assistant
ICON CLINICAL RESEARCH
06.2017 - Current
- Assisted Latin America Vice President in Pharma Clinical Operations with business development, sales support, and preparation of capabilities for customer sales, BID defenses, and regional RFPs.
- Managed Site Engage program, overseeing survey results, performing data analysis, and driving target metrics for PoFC.
- Planned, scheduled, and coordinated monthly project review sessions, collaborating with CTMs, SALs, and COMs to facilitate data-driven discussions and follow-up actions.
- Oversight of operations metrics compliance in the region including productivity & compliance, patient recruitment, PRM resources, MUCs, and OCE/MAVs compliance.
- Active member of the Core Re-monitoring team for a consistent standardized internal process for evaluation, management, and impact of findings at the site.
- Developed a risk analysis framework to establish an effective escalation path for addressing concerns.
- Contributed to the Core steering committee for the employee experience program, managing the annual budget and coordinating activities to promote work-life balance.
CRA I, II
ICON CLINICAL RESEARCH
07.2015 - 06.2017
- Independently set up and monitored studies, completed reports, and maintained study documentation to ensure thorough oversight.
- Verified data in CRFs against patient clinical notes, performing source data verification (SDV) and source data review (SDR) for centralized monitoring accuracy.
- Established procedures to optimize patient management in clinical trials.
- Complied with procedures for addressing serious adverse events to safeguard participant safety in trials.
High – Cost drugs Project Coordinator. (PARA TI)
RIESGO DE FRACTURA S.A CAYRE
12.2014 - 07.2015
- Coordinated patient's high-cost diseases program, fostering collaboration among specialties to enhance quality of life for patients and families.
- Ensured the availability of high-cost drug dispensing and administration.
- Sourced alternatives to ensure resource availability and effective budget management.
Special Projects and Education Coordinator.
RIESGO DE FRACTURA S.A CAYRE
04.2013 - 12.2014
- Coordinated special projects led by scientific management, overseeing programs for clinical trials and pharmaceutical monitoring of long-term safety in chronic autoimmune diseases.
- Implemented and managed Quality Management System in clinical research and medical services, focusing on specialized certification processes with ICONTEC.
- Managed quality standards for Joint Commission International to attain certification for Centre of Excellence in Rheumatoid Arthritis.
CRA
GLAXOSMITHKLINE MADRID, SPAIN.
01.2012 - 01.2013
- Monitoring and management of clinical trials and epidemiology studies in the medical department / respiratory.
- Assure compliance with local regulations, International Conference of Harmonization (ICH) and GCP guidelines.
- Maintained regulatory documentation according to Essential Regulatory Document Guidelines and Trial Master File Plan, supporting trial compliance.
- Submitted regulatory packages to ethics committees.
- Conducted site visits including Site Initiation, Monitoring, Closeout, and Follow-Up visits.
- Ensured timely reporting of Adverse Events (AE)/Serious Adverse Events (SAE) and protocol violations to maintain study integrity.
Clinical Trial Coordinator
Riesgo de Fractura S.A – CAYRE
02.2011 - 12.2011
- Coordinate functions of Phase IIIa and IIIb of clinical trials in autoimmune diseases such as psoriasis and rheumatoid arthritis.
- Monitored adherence to study protocol and goals in collaboration with principal investigator and research staff.
- Facilitated recruitment and retention of study subjects to ensure adequate participant enrollment.
- Ensured compliance with Good Clinical Practices (GCP) and relevant regulations during clinical trials.
- Participate in the planning and conduct of research.
- Data management including data cleaning, and variable creation.
- Extract and analyze data from medical charts.
- Participated in study and research operations meetings to remain updated on IRB and study developments.
- Maintain communication among team members and site staff.
Education
Executive Master of Business Administration - Master Degree
Polytechnic University of Valencia
01.2017
Master of Business Administration - Master Degree
Sergio Arboleda University
01.2016
Monitoring and Management of Clinical Trials - Master Degree
European School of Pharmastudies
01.2013
Bachelor of Bacteriology - Degree
Pontificia Universidad Javeriana
01.2010
Skills
- Data management
- Quality assurance
- Risk assessment
- Data analysis
- Project coordination
- Business development
- Stakeholder engagement
- Decision-making
- Problem solving
- Task prioritization
- Teamwork and collaboration
- Effective communication
Languages
Spanish, High, High, High
Strengths - Gallup Test
- Learner
- Achiever
- Communication
- Problem-Solving
Timeline
Sr. CRA II
ThermoFisher/PPD
05.2024 - Current
Management Assistant
ICON CLINICAL RESEARCH
06.2017 - Current
CRA I, II
ICON CLINICAL RESEARCH
07.2015 - 06.2017
High – Cost drugs Project Coordinator. (PARA TI)
RIESGO DE FRACTURA S.A CAYRE
12.2014 - 07.2015
Special Projects and Education Coordinator.
RIESGO DE FRACTURA S.A CAYRE
04.2013 - 12.2014
CRA
GLAXOSMITHKLINE MADRID, SPAIN.
01.2012 - 01.2013
Clinical Trial Coordinator
Riesgo de Fractura S.A – CAYRE
02.2011 - 12.2011
Executive Master of Business Administration - Master Degree
Polytechnic University of Valencia
Master of Business Administration - Master Degree
Sergio Arboleda University
Monitoring and Management of Clinical Trials - Master Degree
European School of Pharmastudies
Bachelor of Bacteriology - Degree
Pontificia Universidad Javeriana