Quality Control Coordinator I

This is a fully remote position, open to applicants in United States.

📋 Description

• Carry out Quality Control activities on IRB and staff documentation to ensure accuracy in relation to primary sources and adherence to Advarra quality control standards, federal regulations, and timelines.

• Review and analyze documents critically for content accuracy based on assigned submission types.

• Provide clear feedback to Research Services staff regarding any missing or incomplete components.

• Manage daily workload priorities with flexibility and adaptability.

• Implement procedures in accordance with internal quality standards and external regulations.

• Assist the supervisor or director in achieving the team's performance goals through prompt processing of assigned tasks.

• Appropriately escalate workflow issues and proactively suggest process enhancements.

• Conduct quality control for recruitment, subject-facing, translated, and generic material submissions.

• Perform quality control on site modifications, including changes to investigators, sub-investigators, locations, informed consents, HIPAA, or eConsent requests.

• Engage in team and departmental professional and personal development initiatives.

• Carry out other duties as assigned.

⛳️ Requirements

• Bachelor’s degree in health science or a related field, or a comparable combination of education and experience.

• Over 1 year of experience in an office setting, ideally within a regulated industry.

• Fundamental understanding of federal laws and guidelines concerning Human Subjects Research Protection.

• Proficiency in MS Word and Outlook.

• Familiarity with Excel, PowerPoint, direct messaging applications like Slack, remote meeting applications such as Zoom, and web-based proprietary software.

• Capability to work independently with sound judgment, attention to detail, and accountability.

• Ability to concentrate on and manage tasks and responsibilities effectively.

• Proficient verbal communication, listening skills, and the ability to respond and articulate effectively.

• Capacity to sit or stand for extended periods at a stationary workstation.

• Ability to regularly lift, carry, and lower objects weighing up to 10 lbs.

🏝️ Benefits

• Variable bonus eligibility.

• Health coverage.

• Paid holidays.

• Equal opportunity and inclusive workplace.