Research Operations Post Approval Specialist

Cleveland Clinic • Cleveland, OH

1d • Hybrid

About The Position

The Research Operations Post Approval Specialist coordinates and implements Cleveland Clinic’s Research Operations Post Approval Monitoring Program. The role conducts risk-based monitoring to evaluate clinical research documentation and processes, identify noncompliance, and mitigate research-related risks. The specialist collaborates with institutes to assess research risks and ensure adherence to applicable regulations, Good Clinical Practice (ICH-GCP) guidelines, Cleveland Clinic policies, and approved study protocols. The role also identifies educational needs and delivers training based on monitoring findings and trends, providing specialized monitoring support across institutes as part of a centralized team.

The position follows a hybrid schedule from 8:00 a.m. to 5:00 p.m. and may require travel to Cleveland Clinic regional sites, primarily within Ohio. It is on-site during the first 90 days of the new-hire period. The specialist may support presentations of data, trends, and risk assessments to the IRB and Research Compliance Director, regulatory-change communications, external inspections, formal responses to regulatory inquiries, research risk assessments, and institute compliance committee activities.

Requirements

• Bachelor's degree from an accredited college or university and 5 years of recent clinical trials research experience; or an advanced degree in a healthcare or science field and 3 years of recent clinical trials research experience; or an associate degree and 7 years of relevant experience; or a high school diploma and 9 years of relevant experience.
• Successfully complete Human Subjects Research (HSR) certification within 90 days of hire, as required by Cleveland Clinic Responsible Conduct of Research guidelines.
• Direct experience and knowledge of Good Clinical Practice (ICH-GCP) and federal, state, and local healthcare laws and regulations.
• Proficient computer skills, including Excel, Word, Outlook, Access, PowerPoint, and the Epic electronic medical record.
• High level of discretion in handling sensitive and confidential information.
• Strong written and oral communication skills.
• Ability to take initiative, prioritize tasks to meet deadlines, produce results, and cope with inherent pressures.
• Ability to perform multiple tasks accurately and with attention to detail.

Nice To Haves

• Advanced degree in a healthcare- or science-related field.
• Certification in a clinical research specialty.
• Registered Nurse (RN) license in the State of Ohio.
• Clinical research certification from SOCRA and ACRP.
• Project management experience and a strong understanding of root cause analysis and process improvement.
• Experience reviewing clinical trial documentation and processes for compliance with study protocols, institutional policies, applicable regulations, and Good Clinical Practice (GCP).
• Previous experience as a Research Coordinator directly managing clinical trial documentation and compliance processes.
• Experience participating in root cause analysis and developing and implementing effective CAPA plans.

Responsibilities

• Plan, schedule, and conduct monitoring activities according to a risk-based work plan to assess risk.
• Analyze and interpret applicable regulations, including federal and local laws, ICH-GCP guidelines, Cleveland Clinic policies, and other relevant guidance, and assess adherence.
• Document and present detailed compliance findings and recommendations in a timely manner, citing relevant regulations, policies, and guidance; include root cause analysis where appropriate.
• Assist research teams in resolving issues and ensure corrective and preventive action (CAPA) plans are appropriate and implemented in a timely manner.
• Maintain accurate documentation of monitoring reports, investigative findings, corrective actions, and final resolutions.
• Collect data on monitoring findings; prepare reports and metrics; and analyze trends to identify process failures and inform quality improvement and training initiatives.
• Assist in monitoring adherence to policies and action plans to measure program effectiveness.
• May assist the Research Operations Post Approval Monitoring Manager with presenting data, trends, and risk assessments to the IRB and Research Compliance Director.
• May communicate regulatory changes, provide current and accurate information and resources to research caregivers, and update procedures according to best practices.
• Identify enterprise-wide trends and gaps to determine educational opportunities.
• Assist in managing external inspections by regulatory agencies or third parties.
• May assist in preparing formal responses to governmental or other regulatory inspections and inquiries.
• May participate in research risk assessment with institute clinical research leaders.
• May participate in compliance committee activities for supported clinical institutes.
• Perform other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED