Teresa Cinton, COA
El Paso,Texas
Summary
With over 20 years of experience in Phase 1-IV clinical trials, I have contributed to a wide range of indications including Dry Eye Disease, Presbyopia, Post Cataract Inflammation, Ptosis, Glaucoma, and Meibomian Gland Disease. As the Primary Research Coordinator for over 125 clinical trials, my extensive knowledge of medical terminology, meticulous attention to detail, and exceptional communication skills have consistently ensured the smooth execution of these trials. Fluent in both English and Spanish, enabling effective communication with diverse study participants.
Overview
35
35
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator
Lexitas Pharma Services, Inc.
02.2023 - Current
- Tracks multiple aspects of the study and communicates information to the study team, escalating issues as appropriate
- Provides administrative support for amendments, trackers, and follow-up with sites
- Develops and provides reports to update study management and summarize study progress and status
- Responsible for site support during study start-up
- As directed by the study team, communicates with site staff regarding the collection and status of essential documents, study supplies, mass communications, enrollment survey follow-up, and other study related information and actions
- Assists study team in collection and tracking of essential documents, IRB submissions, procurement and shipment of supplies to sites
- Assists with review of both internal and external documents, including essential documents and IRB applications
- Maintains clinical trial master files (TMF and eTMF) and keeps all documentation current
- Assists with inventory of the TMF/eTMF
- Provides meeting agendas, minutes and action items for study related meetings
- Coordinates study team activities on behalf of study management
- Performs other tasks as directed by line management or project leadership
Clinical Research Manager
Louis M. Alpern, MD
03.1998 - 02.2023
- Recruits and screens potential study participants and performs intake assessments
- Maintains all regulatory documents and records related to each clinical study
- Maintaining detailed records of studies as per FDA, ICH, GCP guidelines, including things such as drug dispensation and accountability logs
- Maintain and update all study research team’s documents such as CV’s, licenses, certificates, and GCP training
- Complete and prepares all regulatory documents for the startup of a new clinical trial
- Complete all IRB submissions, including, new study start up, continuing review, end of study, protocol violations, adverse event, and serious adverse events
- Maintain all subject source, ICF and logs for each study
- Complete data entry to EDC, IVRS systems and responsible for query resolution
- Perform IP accountability and compliance
- Author and update site’s SOPs
Certified Ophthalmic Assistant
Louis M. Alpern, MD
03.1990 - 02.2023
- Performed complete patient history and workup including diagnostic testing as required by doctor
- Informed patient of the purpose of all tests personally performed and how they would be affected during the tests
- Performed accurate and consistent documentation and measurement tasks to include recording of all diagnostic tests
Education
Skills
- Good clinical practices
- Electronic data capture
- Documentation management
- Adverse event reporting
- Informed consent
- Study protocols
- Informed consent process
- Investigational product management
- Research experience
- Clinical research ethics
- Medication dispensing
- Subject retention strategies
- Site management
- Study monitoring
- Case report management
- Good clinical practice
- Dispensing oversight
- Adverse event tracking
- Time management
- Problem-solving
- Teamwork and collaboration
- Multitasking Abilities
- Critical thinking
- Quality assurance
- Task prioritization
- Teamwork
- Attention to detail
Therapeutic Areas Of Experience
- Ophthalmology
- Dry Eye Disease
- Meibomian Gland Disease
- Blepharoptosis
- Pterygium
- Post Cataract Inflammation
- Presbyopia
- Glaucoma
Affiliations
SOCRA
ACRP
JCAHPO
Certification
Certified Ophthalmic Assistant
Languages
English
Native or Bilingual
Spanish
Native or Bilingual
Timeline
Clinical Research Coordinator
Lexitas Pharma Services, Inc.
02.2023 - Current
Clinical Research Manager
Louis M. Alpern, MD
03.1998 - 02.2023
Certified Ophthalmic Assistant
Louis M. Alpern, MD
03.1990 - 02.2023