Angela Aguas, MD
St. Petersburg,FL
Summary
Clinical Research professional with over 4 years of experience in Phase II to Phase IV clinical trials across gastrointestinal, immunology, endocrinology, pulmonology, and neurology therapeutic areas.
Clinical Research Associate and former Lead Clinical Research Coordinator with a strong background in site management, regulatory compliance, GCP/ICH guidelines, subject recruitment, monitoring, and data quality oversight.
Currently serving as a Primary CRA responsible for independently managing over 19 investigative sites, conducting qualification, initiation, interim monitoring, and closeout visits, while partnering with investigators and site staff to ensure protocol compliance, subject safety, and data integrity. Demonstrated ability to identify risks, drive issue resolution, support database lock activities, and maintain high-quality study execution.
Doctor of Medicine graduate with strong scientific and clinical knowledge and proven success building collaborative relationships with investigative sites and cross-functional study teams.
Overview
4
4
years of professional experience
1
1
Certification
Work History
CRA1
IQVIA- FSP Eli Lilly
Remote
03.2025 - Current
- Perform site monitoring visits (selection, initiation, monitoring, and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Collaborate and liaise with study team members for project execution support as appropriate.
- Worked effectively in fast-paced environments.
- Proven ability to learn quickly and adapt to new situations.
- Self-motivated, with a strong sense of personal responsibility.
- Skilled at working independently and collaboratively in a team environment.
Lead Clinical Research Coordinator
Theia Clinical Research
St. Petersburg, FL
02.2022 - 02.2025
- Trained new/current site staff on protocol procedures and Good Clinical Practice guidelines.
- Managed and submitted regulatory documents with multiple IRB institutions.
- Created and maintained source documentation and performed data entry into Electronic Data Capture.
- Collected, processed, and shipped lab specimens.
- Coordinated screening visits and enrolled subjects into clinical trials.
- Coordinated pre-site selection visit, investigator meeting, site initiation visit, interim monitoring visits, and trial close out visits.
- Screened patient records, databases, and physician referrals to identify prospective candidates for clinical trial studies.
- Documented IP accountability, temperature excursions, and shipments.
- Managed multiple studies efficiently in order to complete all tasks within deadlines.
- Coordinated all clinical research activities for research site.
- Ensured timely reporting of adverse events or safety concerns to regulatory authorities.
- Organized investigator meetings, training sessions, and other events related to clinical studies.
Education
Doctor of Medicine - Medicine
Windsor University School of Medicine
Saint Kitts And Nevis11.2014
Bachelor of Science - Biology
University of South Florida
United States12.2003
Skills
- Teamwork and collaboration
- Problem-solving
- Multitasking
- Critical thinking
- Organizational skills
- Attention to detail
- Query Management
- Source Data Verification (SDV)
- Risk-Based Monitoring
- Drug Accountability
- Trial Master File (TMF)
- Investigator Site File (ISF)
- ICH-GCP E6(R3)
- Clinical Trial Management
System and Vendor Experience
- Medidata
- Inform
- Veeva CDMS
- Veeva Vault
- CRIO
- eClinicals
- RealTime
- Firecrest
- SubjectWell
- ACM Global
- IQIVA Q2 Labs
- Clinspark
- PPD
- LifeSphere
- Clario
- 4G Clinical
- Fetch
- Exostar
- SIP
- Suvoda
- JUDI
Certification
- Educational Commission For Foreign Medical Graduate (ECFMG), 2015
- ICH GCP E6 r3 Training 2025-06-05
Language(s)
Spanish: Fluent in Speaking, Reading, Writi
Native or Bilingual
English: Fluent in Speaking, Reading, Writing
Therapeutic Experience
Immunology / Rheumatology
- Psoriatic Arthritis
- Rheumatoid Arthritis
- Ulcerative Colitis
- Steatohepatitis (NASH)
- Type 2 Diabetes
- COPD
- Asthma
- Parkinson’s Disease
- Sleep Disorders
- COVID-19
Timeline
CRA1
IQVIA- FSP Eli Lilly
03.2025 - Current
Lead Clinical Research Coordinator
Theia Clinical Research
02.2022 - 02.2025
Bachelor of Science - Biology
University of South Florida
Doctor of Medicine - Medicine
Windsor University School of Medicine