Remote QA & Compliance Lead for Clinical Trials

Rovia Clinical Research; United States; Remote; USD 110,000 - 160,000; Full time

Job summary

Rovia Clinical Research is seeking a QA and Compliance Manager to ensure regulatory and quality standards across clinical studies. The role focuses on audits, SOP oversight, adverse event reporting, and training staff in QA practices.

You will lead investigations into deviations and work with sponsor monitors and inspectors. The position is fully remote with occasional site travel (approximately 20%), and candidates located in the Eastern or Central zones are preferred.

Qualifications

• Strong knowledge of ICH/GCP, FDA regulations and HIPAA policies.
• Experience conducting audits and managing quality systems in clinical trials.
• Ability to lead investigations, corrective and preventive actions.

Responsibilities

• Implements and maintains quality assurance policies and procedures.
• Conducts regular audits of clinical trial activities to ensure compliance with regulatory requirements and internal standards.
• Oversees adverse event reporting and compliance documentation.
• Manages SOPs to ensure compliance and efficiency.
• Establishes and reports on quality indicators.
• Trains staff on QA practices and regulatory regulations.

Skills

ICH/GCP knowledge

FDA inspections experience

Regulatory compliance

Quality_management

Education

Bachelor's degree in life sciences or related field

Compliance certification preferred

Job description

Rovia Clinical Research is seeking a QA and Compliance Manager to ensure regulatory and quality standards across clinical studies. The role focuses on audits, SOP oversight, adverse event reporting, and training staff in QA practices.

You will lead investigations into deviations and work with sponsor monitors and inspectors. The position is fully remote with occasional site travel (approximately 20%), and candidates located in the Eastern or Central zones are preferred.