Senior Clinical Research Lead — Trials & Compliance

Folio Clinical Research; Skokie (IL); Hybrid; USD 65.000 - 85.000; Vollzeit

Zusammenfassung

Folio Clinical Research in Skokie, IL seeks a Lead Clinical Research Coordinator to manage all clinical trial activities under the PI. The role focuses on regulatory compliance, documentation, and coordination with sponsors and CROs.

You will interact with patients during screening, facilitate informed consent, and ensure quality and timeliness across study operations. A strong background in clinical research is required.

Qualifikationen

• Bachelor's degree or equivalent in science/health.
• Five years of Clinical Research Coordinator experience.
• Experience with EDC, CTMS, and eTMF systems.
• Knowledge of ICH-GCP and regulatory requirements.
• Experience ensuring patient safety and data integrity.

Aufgaben

• Ensure regulatory compliance with federal regulations, institutional policies, and sponsor requirements.
• Maintain secure, accurate study documents including consent forms and CRFs.
• Support PI to meet IRB approvals, safety requirements, and financial terms.
• Coordinate with Sponsors, CROs, and internal teams to advance study progress.
• Participate in SQVs, SIVs, IMVs, and other key study meetings.
• Identify obstacles and propose solutions to maintain study momentum.
• Manage study inventory and equipment needs.

Kenntnisse

Interpersonal communication

Attention to detail

Time management

Problem solving

Ausbildung

Bachelor's degree in science or health-related field

Tools

EDC

CTMS

eTMF

IXRS

RTSM

MS Office

PowerPoint

Jobbeschreibung

Folio Clinical Research in Skokie, IL seeks a Lead Clinical Research Coordinator to manage all clinical trial activities under the PI. The role focuses on regulatory compliance, documentation, and coordination with sponsors and CROs.

You will interact with patients during screening, facilitate informed consent, and ensure quality and timeliness across study operations. A strong background in clinical research is required.