• People Leadership and Team Development: Lead and support Data Coordinators by setting clear expectations, assigning work, coaching performance, and building team capability through training, feedback, and knowledge sharing.
• Operational Oversight and Capacity Management: Set daily and weekly priorities across assigned studies and sites, balancing team capacity with participant visits, sponsor timelines, monitoring activity, and database milestones. Identify risks early and adjust plans to maintain service levels.
• Data Quality and Compliance Governance: Maintain quality control practices for source review, EDC/CRF transcription, reconciliation, and documentation. Review performance trends and confirm activities align with protocol, GCP, sponsor requirements, and Care Access procedures.
• Query and Issue Escalation Management: Track open, aging, and high-risk queries; remove barriers to resolution; and coordinate escalations with site teams, investigators, sponsors, CROs, and internal quality and operational compliance partners. Ensure decisions and follow-up actions are documented in approved systems.
• Process Improvement and Reporting: Define and monitor site-level metrics for quality, timeliness, workload, and recurring issues. Standardize best practices, improve workflows, and communicate performance trends and risks to leadership.
• Cross-Functional Partnership: Work with Clinical Operations, Operational Compliance, site leadership, and study teams to align data coordination activities with study requirements and network priorities. Join sponsor, monitoring, and internal operational meetings as needed.
• Other Responsibilities:
  • Support the rollout of new studies, tools, reports, and process changes.
  • Contribute to audit and inspection readiness by reviewing follow-up items, trends, and quality issues.
  • Take on other duties and special projects that align with the role.

• Strong understanding of clinical research data workflows, including source documentation, EDC/CRF entry, query management, reconciliation, and documentation practices.
• Ability to lead and develop a remote team, set accountability, and manage competing priorities.
• Working knowledge of GCP, protocol compliance, sponsor expectations, and quality management principles.
• Ability to analyze data, identify trends and risks, and lead practical process improvements.
• Clear written and verbal communication skills, with the ability to work effectively with site teams, investigators, sponsors, CROs, and internal stakeholders.
• Proficiency with Microsoft Office and clinical research systems, including EDC platforms and quality management systems.

Certifications/Licenses, Education, and Experience

• Minimum Education:
  • High school diploma or GED required; bachelor’s degree in life sciences, healthcare, clinical research, or a related field preferred.
• Minimum Experience:
  • Five or more years of experience in clinical research, clinical data management, site coordination, or a related area required, including at least two years leading, coaching, or coordinating the work of others.
  • Experience supporting multi-site clinical research operations and sponsor-facing data activities preferred.
  • Experience reviewing, entering, reconciling, or maintaining structured data in electronic systems, spreadsheets, trackers, or databases.
  • Experience working with confidential or regulated information, with a focus on accuracy, documentation quality, and appropriate information handling.
  • Familiarity with electronic data capture systems, case report forms, clinical source documentation, and query resolution preferred.