Clinical Research Coordinator

Benefits:

Company parties

Competitive salary

Health insurance

Opportunity for advancement

Paid time off

Training & development

Position: Clinical Research Coordinator (Experienced)

Location: Charlotte, NC Schedule: Full‑time, on‑site Education Requirement: Associate’s degree or nursing certificate Experience Requirement: Minimum 1+ year of hands‑on CRC experience

About the Role

We are seeking an Experienced Clinical Research Coordinator to support the conduct of clinical trials across multiple therapeutic areas. The ideal candidate is detail‑oriented, proactive, and comfortable managing study visits independently while maintaining exceptional participant care and regulatory compliance.

Key Responsibilities

Study Coordination — Manage day‑to‑day study operations, ensuring strict adherence to protocol, GCP, and site SOPs.

Participant Management — Recruit, screen, consent, and schedule participants; conduct study visits and assessments.

Informed Consent — Lead the consent process with clarity, accuracy, and ethical compliance.

Source Documentation — Maintain complete, audit‑ready source documents and reconcile with EDC entries.

Data Entry & Query Resolution — Enter high‑quality data, resolve queries promptly, and meet sponsor deadlines.

Regulatory Support — Assist with IRB submissions, essential documents, delegation logs, and training records.

Specimen Processing — Process, label, centrifuge, freeze, and ship biological samples per protocol.

Safety Reporting — Document and report AEs/SAEs; collaborate with investigators on assessments.

Monitor & Sponsor Interaction — Prepare for monitoring visits, respond to findings, and maintain professional communication.

Study Supplies — Track inventory, maintain equipment logs, and ensure visit readiness.

Required Qualifications

Associate’s degree in a health‑related field or nursing certificate/degree (LPN, RN, BSN with clinical experience)

Minimum 1+ year of experience as a Clinical Research Coordinator

Proficiency with EDC systems (Rave, Inform) and Microsoft Office

Ability to perform vitals, ECGs, phlebotomy, and sample processing

Strong understanding of GCP, ICH, FDA regulations, and IRB processes

Excellent communication, organization, and time‑management skills

Preferred Qualifications

Experience in oncology, immunology, cardiology, or CNS

Familiarity with PK/PD sampling or complex visit schedules

Experience with eReg systems (Veeva)

Bilingual skills

What We Offer

Competitive compensation

Opportunities for professional development and advancement

Supportive team environment

Exposure to diverse therapeutic areas and study types