Research Compliance & Post-Approval Monitor

ccf; Oklahoma; Sur place; USD 80 000 - 110 000; Plein temps

Résumé du poste

Cleveland Clinic's Main Campus seeks a Research Operations Post Approval Specialist to coordinate the post-approval monitoring program, conduct risk-based reviews, and ensure adherence to ICH-GCP, policies, and study protocols. You will collaborate with multiple institutes to promote regulatory compliance and patient safety.

The role emphasizes training, trending, and CAPA actions, with on-site responsibilities during the initial period and potential travel to regional sites in Ohio.

Qualifications

• Bachelor's degree and 5 years of recent experience in clinical trials research
• Advanced degree in healthcare or science with 3 years of recent experience in clinical trials research
• Associate degree and 7 years of relevant experience
• High School Diploma and 9 years of relevant experience
• Within 90 days of hire, must complete certification in Human Subjects Research (HSR)
• Direct experience and knowledge of ICH-GCP and regulatory laws
• Proficient computer skills (Excel, Word, Outlook, Access, PowerPoint)

Responsabilités

• Plan, schedule, and conduct monitoring activities per risk-based plan
• Analyze adherence to regulations, including ICH-GCP and policies
• Document and present compliance findings with root cause analysis
• Support CAPA development and timely implementation
• Maintain monitoring reports and action resolutions
• Prepare data-driven reports and trends for quality improvements
• Assist in regulatory inspections and responses
• Support training and education across institutes

Connaissances

ICH-GCP knowledge

Regulatory compliance

Data analysis

Formation

Bachelor's degree

Advanced degree in healthcare or science

Associate degree

High School Diploma

Outils

Excel

Word

Outlook

Access

PowerPoint

Description du poste

Cleveland Clinic's Main Campus seeks a Research Operations Post Approval Specialist to coordinate the post-approval monitoring program, conduct risk-based reviews, and ensure adherence to ICH-GCP, policies, and study protocols. You will collaborate with multiple institutes to promote regulatory compliance and patient safety.

The role emphasizes training, trending, and CAPA actions, with on-site responsibilities during the initial period and potential travel to regional sites in Ohio.