Clinical Research Coordinator

Job Description

Job Description

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