Research Operations Post Approval Specialist

ccf; Oklahoma; On-site; USD 80,000 - 110,000; Full time

Job summary

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)

Responsibilities

• 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

Skills

ICH-GCP knowledge

Regulatory compliance

Data analysis

Education

Bachelor's degree

Advanced degree in healthcare or science

Associate degree

High School Diploma

Tools

Excel

Word

Outlook

Access

PowerPoint

Job description

Job Title

Research Operations Post Approval Specialist

Location

Cleveland

Facility

Cleveland Clinic Main Campus

Department

RES Clinical Research Resources-Research Innov and Educ

Job Code

T97716

Shift

Days

Schedule

8:00am-5:00pm

Job Summary

Join Cleveland Clinic's Main Campus where research and surgery are advanced, technology is leading-edge, patient care is world class and caregivers are family. Here, you will work alongside a passionate and dedicated team, receive endless support and appreciation, and build a rewarding career with one of the most respected healthcare organizations in the world.

Job Details

As a Research Operations Post Approval Specialist, you will coordinate and implement the Cleveland Clinic Research Operations Post Approval Monitoring Program by conducting risk-based monitoring activities to evaluate clinical research documentation and processes, identify areas of noncompliance, and mitigate research-related risks. In this role, you will collaborate with institutes to assess research risks, ensure adherence to applicable regulations, Good Clinical Practice (ICH-GCP) guidelines, Cleveland Clinic policies, and approved study protocols, and identify educational needs and deliver training based on monitoring findings and trends. As part of a new centralized team, you will provide specialized monitoring support across institutes to promote regulatory compliance and the conduct of clinical research responsible.

A caregiver in this role works a hybrid schedule from 8:00 a.m. - 5:00 p.m. and may travel to other Cleveland Clinic regional sites, primarily within Ohio.

This position is on-site during the first 90 days of the new-hire period.

Responsibilities

• Plan, schedule, and conduct monitoring activities in accordance with a risk-based work plan to assess risk.
• Utilize knowledge and critical thinking to analyze, interpret, and ensure adherence to applicable regulations, including federal and local laws, Good Clinical Practice (ICH-GCP) guidelines, Cleveland Clinic policies, and other relevant guidance.
• Document and present detailed compliance findings and recommendations, citing relevant regulations, policies, and guidance, in a timely manner to allow for proper review and assessment of identified risks, including root cause analysis.
• Exercise appropriate judgment in assisting research teams with resolving issues and ensure corrective and preventive action (CAPA) plans are appropriate and implemented in a timely manner.
• Maintain accurate documentation of all monitoring reports, investigative findings, corrective actions, and final resolutions.
• Assist in collecting data on monitoring findings, preparing comprehensive reports and metrics, and analyzing 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 assist in communicating regulatory changes, providing current and accurate information and resources to research caregivers, and updating procedures according to best practices.
• Assist in identifying trends and gaps across the enterprise 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 the research risk assessment process in partnership with institute clinical research leaders.
• May participate in compliance committee activities for the clinical institutes they support.
• Perform all other duties as assigned.

Minimum Qualifications

• Bachelor's degree from an accredited college or university and 5 years of recent experience in clinical trials research
• OR Advanced degree in healthcare or science field and 3 years of recent experience in clinical trials research
• OR Associate degree and 7 years of relevant experience
• OR High School Diploma and 9 years of relevant experience
• Within 90 days of hire, must successfully complete certification in Human Subjects Research (HSR) as required by the Responsible Conduct of Research guidelines adopted by the Cleveland Clinic
• Direct experience and knowledge of Good Clinical Practice (ICH-GCP), Federal, State, and local healthcare laws and regulations
• Proficient computer skills (Excel, Word, Outlook Access, PowerPoint,