SKY Clinical Research Network Group · 4 hours ago
Lead Clinical Research Coordinator
Union City, GA
Full-time
Onsite
Lead/StaffSKY Clinical Research Network Group is seeking a Lead Clinical Research Coordinator who will provide operational leadership and oversight of clinical research studies. The Lead CRC will ensure protocol compliance, manage subject visit execution, and oversee investigational product accountability while collaborating with the Site Manager on study activities.
Research
Hiring Manager
Shamekia Bennett, BS, CCRP
Responsibilities
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
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
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
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
Perform and/or coordinate DEXA scans, including the completion, tracking, and documentation of all outside DEXA scans, as required per protocol
Qualification
Required
Operational leadership and oversight of clinical research studies
Ensuring protocol compliance
Subject visit execution
Investigational product (IP) accountability
Regulatory maintenance
Serving as a DEXA technician
Management of Clinical Research Coordinators (CRCs)
Collaboration with Site Manager for study start-up, execution, maintenance, and close-out activities
Compliance with ICH-GCP and IRB requirements
Maintaining subject visit schedules
Ensuring subject visit compliance across all CRCs
Overseeing investigational product (IP) accountability
Maintaining the regulatory binder
Participation in Site Initiation Visits (SIVs) and sponsor or CRO meetings
Resolution of data, lab, and imaging queries
Providing subject study status updates to Site Manager
Collecting, organizing, and submitting study start-up documents
Creating and maintaining study-specific checklists
Completing continuing review and study termination IRB submissions
Providing guidance on protocol requirements and documentation standards
Supporting training, onboarding, and professional development of CRC staff
Ensuring site staff have appropriate access to study systems
Monitoring staff training completion and system access readiness
Promoting a culture of compliance and continuous improvement
Performing and/or coordinating DEXA scans
Company
SKY Clinical Research Network Group
Diversity and efficiency are at the core of SKYCRNG's operations.
Founded in 2016
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase