Quality Control Coordinator II

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

📋 Description

• Conduct Quality Control activities on IRB and staff documentation to ensure alignment with primary sources and adherence to Advarra quality control standards, federal regulations, and timelines.

• Review and thoroughly analyze documents for content accuracy related to assigned submission types.

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

• Manage daily workload priorities with flexibility and adaptability.

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

• Support the supervisor or director's vision for team performance by timely processing of delegated tasks, addressing workflow concerns, and offering proactive suggestions for process improvements.

• Engage in professional and personal development initiatives within the team and department.

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

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

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

• Carry out other assigned duties as required.

⛳️ Requirements

• 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.

• Basic understanding of federal laws and guidelines related to Human Subjects Research Protection.

• Proficient in MS Word and Outlook.

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

• Ability to sit or stand for prolonged periods at a stationary workstation.

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

• Ability to learn and understand basic instructions.

• Strong focus and attention to tasks and responsibilities.

• Effective verbal communication skills, including listening, understanding, responding, and speaking.

🏝️ Benefits

• Variable bonus eligibility.

• Health coverage.

• Paid holidays.