Required stack
필요 기술
Project ManagementDocumentationData ManagementClinical ResearchGCPICH GuidelinesRegulatory AffairsCTMSeCRFParticipant RecruitmentClinical Data CollectionAdverse Event Reporting
Project brief
프로젝트 내용
I’m Bob Settineri, CRO at Sierra Productions Research, and we’re about to launch a pilot study on a new dietary supplement at our Irvine, CA clinic. I need an experienced registered nurse to step straight into the role of Clinical Research Coordinator and keep the study moving smoothly from first screening call to database lock.
The trial is a short-term, single-site pilot focused on efficacy evaluation, so tight execution and immaculate documentation are critical. You’ll own every operational detail on site: recruiting and pre-screening potential participants, guiding them through informed consent, coordinating visit schedules with the medical team, collecting vitals and lab specimens, and completing source notes and eCRF entries in real time. Because this is an efficacy-driven project, consistent administration of study product, timely outcome assessments, and accurate AE reporting will be under your watch.
I will provide protocol, CRF templates and access to our cloud-based CTMS. You’ll interface directly with the principal investigator, the clinic staff, and me for sponsor updates. Experience with FDA-aligned GCP, ICH guidelines, and dietary supplement trials is strongly preferred.
Deliverables I’ll be reviewing:
• Up-to-date screening/enrollment log with signed consents
• Completed source documents and matching eCRF entries for every visit
• Maintained regulatory binder (including delegation log, CVs, licenses, training records)
• Weekly status email summarising enrollment progress, data entry completeness, and any protocol deviations
• Close-out package ready for monitor review
The study begins as soon as we lock the final protocol, so availability in Irvine for participant visits is essential. If you’re confident managing an end-to-end pilot and can start quickly, I’d like to hear how your background fits this project.
The trial is a short-term, single-site pilot focused on efficacy evaluation, so tight execution and immaculate documentation are critical. You’ll own every operational detail on site: recruiting and pre-screening potential participants, guiding them through informed consent, coordinating visit schedules with the medical team, collecting vitals and lab specimens, and completing source notes and eCRF entries in real time. Because this is an efficacy-driven project, consistent administration of study product, timely outcome assessments, and accurate AE reporting will be under your watch.
I will provide protocol, CRF templates and access to our cloud-based CTMS. You’ll interface directly with the principal investigator, the clinic staff, and me for sponsor updates. Experience with FDA-aligned GCP, ICH guidelines, and dietary supplement trials is strongly preferred.
Deliverables I’ll be reviewing:
• Up-to-date screening/enrollment log with signed consents
• Completed source documents and matching eCRF entries for every visit
• Maintained regulatory binder (including delegation log, CVs, licenses, training records)
• Weekly status email summarising enrollment progress, data entry completeness, and any protocol deviations
• Close-out package ready for monitor review
The study begins as soon as we lock the final protocol, so availability in Irvine for participant visits is essential. If you’re confident managing an end-to-end pilot and can start quickly, I’d like to hear how your background fits this project.