Clinical Research Coordinator

Lead Clinical Research Coordinator Job Description

Job Title: Lead Clinical Research Coordinator

Reports To: Clinical Research Site Manager

Department: Clinical Operations

Location: On-site (SKYCRNG Network Site)

Position Summary

The Lead Clinical Research Coordinator (Lead CRC) provides operational leadership and oversight of clinical research studies conducted at the site. This role is responsible for ensuring protocol compliance, subject visit execution, investigational product (IP) accountability, regulatory maintenance, and serving as a DEXA technician, while serving as a manager to CRCs. The Lead CRC works closely with the Site Manager to support study start-up, execution, study maintenance, and close-out activities in accordance with ICH-GCP, IRB requirements, sponsor protocols, and SKYCRNG’s Standard Operating Procedures (SOPs).

Key Responsibilities

Study Operations & Compliance

• Maintain and oversee subject visit schedules, ensuring protocol-required visits and procedures are completed accurately and on time.
• Ensure subject visit compliance across all CRCs, including source documentation, protocol adherence, and timely data, imaging, and lab query resolution by CRC staff.
• Oversee and maintain investigational product (IP) accountability, ensuring accurate documentation, storage, reconciliation, and compliance.
• Maintain the regulatory binder, ensuring all essential documents are complete, current, and audit-ready.
• Attend and actively participate in Site Initiation Visits (SIVs) and other required sponsor or CRO meetings.

Data Quality & Query Management

• Oversee the resolution of data, lab, and imaging queries, ensuring timely, accurate responses and appropriate follow-up.
• Collaborate with CRCs to identify trends, recurring errors, or training needs related to source quality and visit compliance.
• Provide ongoing subject study status updates to the Site Manager, including enrollment, visit completion, and outstanding issues.

Study Start-Up & Close-Out & Systems Readiness

• Work closely with the Site Manager to collect, organize, and submit study start-up documents, including regulatory and training materials.
• Create and maintain study-specific checklists to support efficient study execution and consistent CRC workflows.
• Complete continuing review and study termination IRB submissions in accordance with IRB requirements and established timelines.

Leadership, Mentorship & Team Development

• Serve as a manager and subject-matter resource for CRCs, providing guidance on protocol requirements, documentation standards, and best practices.
• Support training, onboarding, and professional development of CRC staff.
• Ensure all site staff have appropriate access to study systems, including EDC, IRT/IXRS, ePRO, imaging platforms, and sponsor portals.
• Monitor and support staff training completion, system access readiness, and protocol-required certifications.
• Promote a culture of compliance, accountability, collaboration, and continuous improvement across the site and SKYCRNG network.

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DEXA & Specialized Procedure Oversight

• Perform and/or coordinate DEXA scans, including the completion, tracking, and documentation of all outside DEXA scans, as required per protocol.

Qualifications

Required

• Minimum 3–5 years of clinical research coordination experience.
• Strong working knowledge of ICH-GCP, IRB requirements, and FDA regulations.
• Proven experience with regulatory binders, IP accountability, and subject visit management.
• Experience working with EDC systems, IRB portals, and sponsor systems.
• Excellent organizational, communication, and leadership skills.

Preferred

• Prior experience in a Lead CRC or Senior CRC role.
• Experience with DEXA scans and imaging-based clinical studies.
• Multi-protocol and multi-therapeutic area experience.
• Professional certification (CCRC, CCRP, or equivalent).

Core Competencies

• Attention to detail and regulatory compliance
• Leadership and team mentorship
• Time management and prioritization
• Data quality oversight and query resolution
• Cross-functional collaboration
• Audit and inspection readiness

Work Environment

• Clinical research site environment
• May require extended hours based on study needs and sponsor visits
• Occasional travel for meetings, monitoring visits, or training, if applicable

SKYCRNG is committed to excellence, integrity, and community-focused research. This role is critical to maintaining our reputation as an audit-ready, enrollment-ready, high-performing clinical research network.

Job Type: Full-time

Work Location: In person