Remote QA & Compliance Lead, Clinical Trials

ROVIA; United States; Remote; USD 90,000 - 125,000; Full time

Job summary

Rovia Clinical Research is seeking a QA and Compliance Manager to ensure that our clinical studies meet regulatory standards and contractual obligations. You will lead quality assurance programs and drive continuous improvement across trial activities, documenting findings and action plans.

The role is fully remote with occasional site travel (20%). The candidate should have strong knowledge of ICH/GCP, FDA/HIPAA policies, and relevant certifications. Eastern or Central time zones preferred.

Qualifications

• Bachelor's degree in a related field or relevant experience.
• CCRC or compliance certification preferred.
• 2+ years CRC experience required.
• 3+ years quality specialist experience required.
• 1-2 years quality management experience required.

Responsibilities

• Implements and maintains QA policies and procedures.
• Audits clinical trial activities for regulatory compliance.
• Oversees adverse event reporting and compliance docs.
• Manages SOPs to ensure compliance and efficiency.
• Establishes, measures, and reports quality indicators.
• Trains staff on QA practices and regulations.
• Collaborates with cross-functional teams for corrective actions.
• Supports sponsor monitoring, audits, and inspections.
• Acts as regulatory liaison during inspections.
• Leads investigations into deviations and prevents recurrence.
• Performs other duties as assigned.

Skills

Clinical trials

ICH/GCP

FDA compliance

HIPAA

Education

Bachelor's degree in related field

ACRP certification

CCRC

Job description

Rovia Clinical Research is seeking a QA and Compliance Manager to ensure that our clinical studies meet regulatory standards and contractual obligations. You will lead quality assurance programs and drive continuous improvement across trial activities, documenting findings and action plans.

The role is fully remote with occasional site travel (20%). The candidate should have strong knowledge of ICH/GCP, FDA/HIPAA policies, and relevant certifications. Eastern or Central time zones preferred.