Lead Clinical Research Coordinator — Trials Leader

Folio Clinical Research; Skokie (IL); On-site; USD 65,000 - 85,000; Full time

Job summary

Folio Clinical Research in Skokie, IL seeks a Lead Clinical Research Coordinator to manage all clinical trial activities under the PI, ensuring regulatory compliance, patient safety, and study efficiency. The role requires collaboration with investigators, sponsors, and site staff to drive high-quality trial execution.

The successful candidate will coordinate regulatory processes, oversee documentation, and maintain study timelines with strong communication and leadership skills.

Qualifications

• Minimum of five years of Clinical Research Coordinator experience.
• Experience with EDC, CTMS, and eTMF systems.
• Understanding of urology and related therapeutic areas.
• In-depth knowledge of ICH-GCP and regulatory requirements.
• Experience with data management and GCDMP.
• Commitment to patient safety and data integrity.
• Strong communication and stakeholder relationship skills.
• Bachelor's degree or equivalent in science/health.

Responsibilities

• Regulatory and institutional compliance support under PI.
• Documentation management of study documents per sponsor and policy.
• Study oversight ensuring IRB approvals and safety requirements.
• Coordinate with Sponsors, CROs, Investigators, Nurses, and staff.
• Participate in SQVs, SIVs, IMVs and other study meetings.
• Identify obstacles and provide solutions to maintain timeline.
• Manage study inventory and equipment.

Skills

Clinical Research Leadership

Regulatory Compliance

Study Coordination

Communication

Problem Solving

Time Management

Team Collaboration

Education

Bachelor's degree or equivalent in science/health

Tools

EDC

CTMS

eTMF

IXRS

RTSM

MS Office

PowerPoint

Job description

Folio Clinical Research in Skokie, IL seeks a Lead Clinical Research Coordinator to manage all clinical trial activities under the PI, ensuring regulatory compliance, patient safety, and study efficiency. The role requires collaboration with investigators, sponsors, and site staff to drive high-quality trial execution.

The successful candidate will coordinate regulatory processes, oversee documentation, and maintain study timelines with strong communication and leadership skills.