Clinical Research Coordinator / Study Coordinator

Key Responsibilities Coordinate and manage Rheumatoid Arthritis clinical trials from start-up to close-out Screen, recruit, and consent patients with RA based on inclusion/exclusion criteria Conduct study visits, including joint assessments, patient-reported outcomes, and follow-ups Assist investigators in evaluating disease activity scores (e.g., DAS28, CDAI, SDAI) Maintain accurate documentation (source documents, eCRFs, regulatory binders) Ensure compliance with ICH-GCP , FDA, and protocol-specific requirements Monitor patient safety and report adverse events (AEs/SAEs), including immunologic reactions Coordinate laboratory sample collection (e.g., biomarkers, inflammatory markers like

CRP, ESR

) Liaise with sponsors, CROs, and multidisciplinary teams (rheumatologists, nurses, lab staff) Manage investigational products, including biologics and immunomodulators Prepare for monitoring visits, audits, and regulatory inspections Track enrollment, retention, and study milestones Qualifications & Requirements Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related field 2-5 years of experience as a Clinical Research Coordinator / Study Coordinator Experience in autoimmune, immunology, or rheumatology trials preferred Strong understanding of Rheumatoid Arthritis and clinical trial methodologies Knowledge of

GCP, FDA

regulations, and clinical research compliance Familiarity with EDC systems (Medidata, Oracle, REDCap, etc.) Excellent organizational and patient management skills Preferred Skills Experience with biologic therapies (e.g., TNF inhibitors, JAK inhibitors) Familiarity with RA disease activity scoring systems (DAS28, CDAI, SDAI) Phlebotomy or clinical patient-care experience Certification such as CCRC or CCRP preferred

Job Type:

Full-time Pay:

$1,800.00 - $2,200.00 per month

Work Location:

In person