Amara Osei
Clinical Research Coordinator II, CCRC · Houston, TX
Summary
CCRC with 5 years coordinating Phase II-III oncology and cardiology trials at an academic medical center. Manages 8 active protocols and a caseload of 45 enrolled participants, has screened 300+ patients, and closed the last 3 sponsor monitoring visits with no critical findings.
Experience
Clinical Research Coordinator II, Lakeshore University Medical Center
Mar 2022 – Present
Houston, TX
- Coordinate 8 active industry-sponsored and NCI cooperative-group trials in oncology; enrolled 38 participants in 2025, 112% of the site's target.
- Screen and consent participants under ICH-GCP and 21 CFR Part 50, verify eligibility against inclusion/exclusion criteria with the PI, and keep the consent audit trail complete.
- Enter and reconcile data in Medidata Rave and Oracle InForm within 5 business days of each visit; reduced open queries by 40% with a weekly query-clearance routine.
- Prepare for sponsor monitoring visits and FDA inspection readiness; the last 3 monitoring visits closed with no critical findings and the site's protocol deviations fell by 30%.
Clinical Research Coordinator I, Lakeshore University Medical Center
Jul 2020 – Feb 2022
Houston, TX
- Supported 5 cardiology trials: scheduled visits, drew and processed study labs, and shipped research samples under IATA guidelines.
- Maintained regulatory binders and submitted amendments, continuing reviews and safety reports to the IRB through the electronic IRB system.
- Reported adverse events and serious adverse events to the sponsor and IRB within protocol timelines; zero late SAE reports in 18 months.
- Managed drug accountability and investigational product storage, with temperature logs and reconciliation completed without discrepancy at each audit.
Skills
ICH-GCP and 21 CFR Parts 11, 50, 56, 312 · Participant screening and informed consent · Protocol adherence and deviation management · EDC systems (Medidata Rave, Oracle InForm) · CTMS (OnCore) · IRB submissions and regulatory binders · Adverse event reporting · Source documentation · Investigational product accountability · Sponsor monitoring and audit readiness
Education
B.S. in Biology, University of Houston, 2020
Certifications
- Certified Clinical Research Coordinator (CCRC), ACRP
- CITI Good Clinical Practice and Human Subjects Research
- Phlebotomy certification