Study Operations Coordinator

Study Operations Coordinator Denver, CO Job Details Full-time $63,000 - $65,000 a year 1 day ago Benefits Health insurance Dental insurance 401(k) Paid time off Vision insurance Flexible schedule Qualifications Quality control corrective actions Project team coordination Financial forecasting Clinical research Operations management Variance analysis RN License Master of Public Health Budget monitoring Compliance audits & assessments Project timeline management Corrective and preventive actions (CAPA) Mid-level Client invoicing Key Performance Indicators Clinical research compliance Bachelor's degree Public Health Operational risk mitigation Vendor relationship management Data entry Clinical trials Research administration Master's degree in public health Vendor contract management Good Clinical Practice Research regulatory compliance Budgeting IRB compliance Financial management Cross-functional collaboration Escalation handling Cross-functional team management 2 years Project stakeholder communication Stakeholder relationship building Cross-functional communication Nursing Stakeholder management Full Job Description The Study Operations Coordinator is the operational owner of assigned industry-sponsored clinical trials and is accountable for execution, timelines, quality, and financial performance from start-up through close-out. This role serves as primary point of contact for sponsors and CROs, ensures clean and compliant study conduct, and drives cross-functional coordination across CRCs, Regulatory, QA, and Finance to deliver predictable, high-quality outcomes. This position reports to the Director of Clinical Operations.

RESPONSIBILITIES

Stakeholder Relationship Management Serve as the day-to-day primary point of contact for sponsors, CROs, and participating sites for assigned studies. Own all routine sponsor communications, updates, and follow-ups. Lead study and governance calls and ensure clear documentation of decisions and action items. Manage and triage sponsor requests, issues, and escalations. Align site execution with sponsor expectations and contractual requirements. Communicate protocol changes, amendments, and operational updates across all internal stakeholders. Proactively identify risks and escalate to the Director of Clinical Operations when needed. Operational Oversight During Study Conduct Own the master study timeline from activation through close-out. Coordinate execution and tracking of site work orders and vendor agreements. Monitor enrollment performance, screen failures, and recruitment trends. Track visit completion, data entry timeliness, and operational KPIs. Review deviations and protocol compliance trends. Support CRCs with operational problem-solving and issue resolution. Ensure monitoring visits are prepared for, conducted smoothly, and fully resolved. Ensure timely and accurate responses to sponsor queries, monitoring findings, and action items. Financial Performance Tracking Track expected vs. actual revenue at the study and site level. Ensure visits, procedures, and milestones are invoiced accurately and on time. Monitor holdbacks, pass-throughs, and delayed payments. Flag budget shortfalls, under-recoveries, and scope creep. Partner with Finance on cash forecasting and revenue projections per study. Actively push sponsors and CROs on delayed or disputed payments. Cross-Functional Coordination Coordinate across CRCs, Regulatory, QA, Finance, IP, and Data to Ensure clean handoffs from start-up to close-out. Maintain study trackers, task lists, and workflows. Drive internal accountability for study commitments and timelines. Review deviations, trends, and CAPAs for assigned studies. Ensure corrective and preventive actions are implemented and effective. Watch for repeat or systemic errors across sites or CRCs. Prepare for audits and monitoring visits. Participate in audit responses and follow-up actions. CRC Coordination & Backup Serve as the primary operational backup for CRCs on assigned studies during absences, high workload periods, or critical milestones. Provide hands-on support for study execution when needed, including patient coordination, visit coverage, data entry, and sponsor communication. Ensure continuity of study activities with no disruption to timelines, data quality, or patient experience. Recommend and coordinate workload redistribution in collaboration with the Director of Clinical Operations. Escalate persistent capacity constraints to the Director of Clinical Operations. Key Accountabilities On-time study start-up, activation, and execution across assigned studies. Working with the Director of Clinical Operations, successful transition from study start-up to active enrollment with no delays or rework. Consistent achievement of enrollment targets and study milestones. High-quality, compliant study conduct with minimal deviations and findings. Strong sponsor satisfaction driven by proactive communication and reliable execution. Accurate, timely invoicing and active management of collections and payment delays. Clear visibility into study financial performance, including revenue tracking and variance identification. Proactive identification and resolution of operational risks impacting timelines, quality, or revenue. Effective coordination across CRCs and departments to ensure accountability and execution.

MINIMUM QUALIFICATIONS

Knowledge, Skills, and Abilities 3-5+ years of clinical research operations experience Direct experience managing industry-sponsored trials preferred Prior sponsor or CRO-facing responsibility Strong understanding of GCP, IRB, and regulatory workflow. Confident in setting boundaries with sponsors and escalating issues internally when appropriate. Highly organized, operationally rigorous, and execution-driven. Education and experience Bachelor's degree required; Licensed Registered Nurse, or Master's in Public Health or another professional field preferred. Two (2) years' experience in clinical research coordination required. Experience in clinical trial study-start-up preferred.

Job Type:

Full-time Pay:

$63,000.00 - $65,000.00 per year

Benefits:

401(k) Dental insurance Flexible schedule Health insurance Paid time off Vision insurance

Experience:

Clinical trials: 2 years (Preferred) Ability to

Commute:

Denver, CO 80222 (Preferred)

Work Location:

In person