What are the responsibilities and job description for the Research Compliance and Quality Coordinator position at Vital Heart & Vein?
We are seeking a detail-oriented and highly organized Compliance and Quality Coordinator to support quality, compliance, and operational excellence across our clinical research department. This role will help ensure that quality is maintained in every department, including eSource, regulatory processes, data management, lab management, and IP management. This position will also support audit readiness, documentation accuracy, and compliance across active clinical studies.
Key Responsibilities
- Perform quality reviews across clinical research operations to ensure compliance and consistency.
- Review eSource documentation, regulatory files, data records, lab processes, and IP accountability for completeness and accuracy.
- Identify gaps in quality, compliance, and workflow processes and escalate findings as needed.
- Support monitoring follow-up responses, internal quality checks, and audit/inspection readiness.
- Assist with the development and maintenance of quality control procedures, logs, and follow-up tracking.
- Work closely with study teams to improve compliance, documentation quality, and operational efficiency.
- Support CAPA tracking and follow-up on quality-related issues.
- Maintain organized records and communicate findings to leadership in a timely manner.
- Help ensure quality standards are followed across all departments and study activities.
- Maintain site SOPs, provide staff training on identified compliance gaps, and generate periodic study-wise quality reports for the Research Director.
Qualifications
- Associate degree or bachelor's degree preferred.
- Experience in clinical research, quality assurance, regulatory, healthcare operations, or related field preferred.
- Strong attention to detail and organizational skills.
- Ability to review documents carefully and identify discrepancies.
- Strong written and verbal communication skills.
- Ability to work independently and collaboratively across departments.
- Proficiency in Microsoft Office applications.
Preferred Experience
- Clinical research experience.
- Knowledge of GCP, protocol compliance, and audit readiness.
- Experience with eSource review, regulatory support, data management, lab oversight, or IP accountability.
- Medical device research experience is required.