Research Operations Post Approval Specialist

Cleveland Clinic • Cleveland, OH

124d

About The Position

Join the Cleveland Clinic team, where you will work alongside passionate caregivers and provide patient-first healthcare. Cleveland Clinic is recognized as one of the top hospitals in the nation. At Cleveland Clinic, you will work alongside passionate and dedicated caregivers, receive endless support and appreciation, and build a rewarding career with one of the most respected healthcare organizations in the world. The Research Operations Post Approval Specialist assists with the coordination and implementation of the CC Research Operations Post Approval Monitoring Program by performing research monitoring activities to assess and mitigate risk. They will assist in the assessment of research education needs as a result of monitoring and trends, delivering educational offerings for investigators, research staff and other members of the HRPP to promote the responsible conduct of research. A caregiver in this position works days from 8:00 AM—5:00PM. After completion of the 90-day new hire period, this caregiver will work a hybrid schedule.

Requirements

• Bachelor's Degree from an accredited college or university and five years of recent experience in clinical trials research.
• High School Diploma and nine years of relevant experience OR Associate's Degree and seven years of relevant experience may substitute for a Bachelor's Degree.
• Successful completion of the Human Subjects Research (HSR) Certification as required by the Responsible Conduct of Research guidelines adopted by the Cleveland Clinic within 90 days of hire.
• Direct experience and knowledge of Federal, State, and local healthcare laws and regulations with ability to apply laws and regulations within healthcare operations.
• Ability to take initiative, prioritize tasks to meet deadlines, produce results and cope with the inherent pressures.
• Ability to perform multiple tasks with a high level of accuracy and attention to detail.
• Proficient computer skills (Excel, Word, Outlook Access, PowerPoint, electronic medical record, Epic, etc.).

Nice To Haves

• Advanced degree in healthcare or science-related field and three years of required experience.
• Clinical Research certification from the Society of Clinical Research Associates (SOCRA) and Association of Clinical Research Professionals (ACRP).
• Project management experience and an excellent understanding of root cause analysis or process improvement.

Responsibilities

• Plan, schedule, conduct and perform monitoring activities.
• Utilize knowledge and critical thinking to analyze, interpret and ensure adherence to applicable regulations including federal and local laws, Good Clinical Practices (ICH-GCP) and CC policies.
• Document and present detailed compliance findings and recommendations (with regulatory citations) in a timely manner that allows for proper review and assessment of the risks identified, 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.
• Collect data on monitoring findings, prepare comprehensive reports and metrics, analyze trends to identify process failures and direct quality improvement and training initiatives.
• Monitor compliance with policies and action plans.
• Identify trends and gaps across the enterprise to determine educational opportunities.
• Assist in the management of external inspections by regulatory agencies or third parties.
• Prepare formal responses to governmental or other regulatory inspections and inquiries.
• Participate in the research risk assessment process and compliance committee activities in partnership with Institute clinical research leaders.

What This Job Offers

• Job Type: Full-time
• Industry: Ambulatory Health Care Services
• Education Level: Bachelor's degree