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Remote Clinical Research Coordinator (Operations - Patient visits, Data Entry, Regulatory, QC) - Contract to Hire

Remote, USA Full-time Posted 2025-11-03
We're a NYC-based, community-embedded clinical research site focused on CNS & metabolic health. We run industry-sponsored trials! Role overview: We’re hiring an experienced remote coordinator to call patients for visits, visit operations, quality assurance, data tasks, query management, while our two in-person CRCs handle patient-facing visits. You’ll keep our EDC/CTMS clean, visits prepped, and monitors happy. What you’ll do (core responsibilities) EDC/CTMS data entry & QC: Enter/verify CRFs, resolve queries within 24–48h, reconcile labs/ECGs/concom meds/AEs against source. Visit readiness (“T-24” checks): Confirm inclusion/exclusion, visit windows, kits/diaries/ePRO assignments, vendor orders, stipend setup, transport bookings, IP accountability paperwork. Monitoring support: Clear action items pre-SDV/SDR, track findings to closure, maintain a zero-backlog dashboard. Regulatory touchpoints (light): File SIV/SQV letters, training logs/DOA signatures, version control of ICFs in eReg (remote workflows). Tracker hygiene: Screen/fail/randomization logs, eligibility trackers, deviation logs, and subject payment logs Visit close-out: Ensure all source uploaded, CRFs complete, queries closed, and packet marked “monitor-ready.” Success looks like (KPIs) ≤48h average query turnaround; Study specific visit checklists On-time EDC entry per protocol/Sponsor SLA. Must-have qualifications Go-getter and positive attitude Curious to learn and constantly improve existing processes 2+ years coordinating industry-sponsored trials (site or CRO), with hands-on EDC (e.g., Medidata Rave, Veeva, REDCap) and CTMS (e.g., RealTime, eClinPro) experience. Working knowledge of ICH-GCP, HIPAA, IRB submissions/portals (e.g., CIRBI). Strong grasp of AE/SAE documentation, con-med/med history reconciliation, and window management. Detail-obsessed, systems-driven, excellent written communication. Overlap with EST time (Time frame likely 10AM - 2PM EST ) Nice-to-haves CNS/metabolic trial experience (Alzheimer’s, MDD, CKD/obesity/cardiometabolic). Vendor portal experience (labcorp, ePRO, Oracle EDC) Basic familiarity with eSource and remote monitoring workflows. ACRP Certification Logistics Start: ASAP Hours : Around 10-20 hours a week What you’ll work on in Week 1 (examples) Build a visit checklist for our current protocols and run it before upcoming visits. Enter subject visit data in EDC Clear the existing query queue and create a weekly monitor-action tracker. Audit subject stipend/travel logs for completeness and CTA/ICF alignment. How to apply Send a short video youtube link with a short note on your coordinating experience and the number of trials you've worked on. Also answer what is the hardest thing you've ever worked on in your life and how hard did you exactly work to get through it? Apply tot his job Apply To this Job

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