Evelyn Roman
Port Neches,TX
Summary
Clinical Research Coordinator with nearly four years of experience. Experienced in study coordination, informed consent, regulatory documentation, adverse event reporting, and sponsor communication. Proven ability to manage multiple protocols while ensuring compliance with GCP and FDA regulations. Currently seeking to obtain ACRP (CCRC) certification to advance into higher-level, growth-focused roles within clinical research.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Lead Clinical Research Coordinator II
Tekton Research
Beaumont, TX
01.2023 - Current
- Ensure strict adherence to study protocols and regulatory guidelines.
- Assist with regulatory documentation, including IRB submissions, continuing reviews, protocol amendments, and adverse event reporting.
- Support investigators and study team with study start-up, execution, and close-out activities
- Order, track, and maintain study supplies, equipment, and investigational materials
- Prepare and review study-related documentation, including protocols, informed consent forms, and reports.
- Conducting and overseeing study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner
- Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s)
- Demonstrated understanding, implementation and supervision of protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration, and laboratory kit inventory for assigned protocols
- Managed participant recruitment efforts, enhancing study enrollment through targeted outreach strategies.
- Gathered, processed, and shipped lab specimens.
- Train other site staff as needed
Clinical Research Assistant
Tekton Research
Beaumont, TX
07.2022 - 12.2022
- Assisted in recruitment and screening of clinical trial participants to ensure eligibility criteria were met.
- Answered telephone calls to offer office information, answer questions, and direct calls to staff.
- Communicate with research participants and address their concerns.
- Coordinate and schedule study visits and follow-ups.
- Assist in the preparation of study-related documents and reports.
Medical Assistant
Peoples Urgent Care
Beaumont, TX
01.2021 - 03.2022
- Administered medications and monitored vital signs for patients
- Escort patients to exam rooms, interviews patients, measure vital signs, including weight, blood pressure, pulse, temperature, and document all information in patient’s chart
- Keep exam rooms stocked with adequate medical supplies, maintain instruments, prepare sterilization as required
- Scheduling of patient appointments
- Collection and verification of insurance and collection of payments appropriately
- Ensure all related reports, labs and information is filed is available in patients’ medical records prior to their appointment
Medical Assistant
Lorelei Capocyan, MD
Sugar Land, TX
03.2017 - 03.2020
- Coordinated appointments, optimizing scheduling to reduce wait times for patients.
- Assisted in patient intake and history documentation, ensuring accuracy and confidentiality.
- Supported physicians during examinations by providing necessary instruments and materials.
- Maintained a safe and clean clinical environment through diligent adherence to infection control guidelines.
- Facilitated referral processes with specialists when necessary, ensuring seamless continuity of care for patients.
- Prepared lab specimens for diagnostic evaluation.
Education
Medical Assistant Certificate
Altierus Career College
HoustonHigh School Diploma -
Sharpstown High School
Houston, TXSkills
- Study closeout
- Study protocols
- Informed consent
- Specimen handling
- Medication dispensing
- Clinical trial management
- Adverse event reporting
- Informed consent process
Certification
• CITI - GCP_ R3
• GCP - (ICH Focus)
• CPR & AED Certified
• OSHA Bloodborne Pathogens/ Biosafety/ Biosecurity
• IATA Shipping Certification
Languages
Spanish
Native or Bilingual
English
Native or Bilingual
Timeline
Lead Clinical Research Coordinator II
Tekton Research
01.2023 - Current
Clinical Research Assistant
Tekton Research
07.2022 - 12.2022
Medical Assistant
Peoples Urgent Care
01.2021 - 03.2022
Medical Assistant
Lorelei Capocyan, MD
03.2017 - 03.2020
Medical Assistant Certificate
Altierus Career College
High School Diploma -
Sharpstown High School