Quality Control Coordinator II

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

📋 Description

• Perform Quality Control tasks on IRB and staff documentation.

• Verify accuracy against primary sources and ensure compliance with Advarra quality control standards, federal regulations, and timelines.

• Review and critically assess assigned submission documents for content accuracy.

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

• Manage daily workload priorities with flexibility and adaptability.

• Implement procedures that comply with internal quality standards and external regulations.

• Assist supervisor or director's vision through timely completion of delegated tasks, escalation of workflow issues, and suggestions for process improvement.

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

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

• Execute initial site reviews and site modifications, including those related to investigator, location, conflict-of-interest, informed consent, HIPAA, and eConsent requests.

• Perform quality control on study-level Protocol or Product Information modifications that do not affect Informed Consent templates.

• Undertake additional duties as assigned.

⛳️ Requirements

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

• A minimum of 1 year of experience in IRB, clinical research, or quality control.

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

• Proficient in MS Word and Outlook.

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

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

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

• Capacity to learn and understand basic instructions.

• Strong focus and attention to tasks and responsibilities.

• Effective verbal communication skills, including listening and responding appropriately.

🏝️ Benefits

• Variable bonus eligibility.

• Health coverage.

• Paid holidays.

• Additional benefits.

• Remote work arrangement.