Research Operations Post Approval Specialist

Cleveland Clinic · Cleveland Clinic Main Campus

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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.  

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.

A caregiver who excels in this role will:

• 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 for the ideal future caregiver include:

• 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, electronic medical record-Epic)
• High level of discretion in handing sensitive and confidential information
• Strong written and oral communication skills
• 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

Preferred qualifications for the ideal future caregiver include: 

• Advanced degree in healthcare or science-related field
• Certified in one of the clinical research certifications
• Licensed as a Registered Nurse (RN), in the State of Ohio
• Clinical Research certification from Society of Clinical Research Associates (SOCRA) and Association of Clinical Research Professionals (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 Corrective and Preventive Action (CAPA) plans

Physical Requirements:

• Ability to perform work in a stationary position for extended periods. 
• Ability to operate a computer and other office equipment. 
• Ability to communicate and exchange accurate information. 
• In some locations, ability to move up to 25 pounds.

Personal Protective Equipment:

• Follow standard precautions using personal protective equipment as required

The policy of Cleveland Clinic Health System and its system hospitals (Cleveland Clinic Health System) is to provide equal opportunity to all of our caregivers and applicants for employment in our drug free environment. All offers of employment are followed by testing for controlled substances.

Cleveland Clinic Health System administers an influenza prevention program. You will be required to comply with this program, which will include obtaining an influenza vaccination on an annual basis or obtaining an approved exemption.

Decisions concerning employment, transfers and promotions are made upon the basis of the best qualified candidate without regard to color, race, religion, national origin, age, sex, sexual orientation, marital status, ancestry, status as a disabled or Vietnam era veteran or any other characteristic protected by law. Information provided on this application may be shared with any Cleveland Clinic Health System facility. 

If applying for a Florida position, please see the following website for more information on the background screening requirements required by the Agency of Health Care Administration: https://info.flclearinghouse.com/

Please review the Equal Employment Opportunity poster. 

Cleveland Clinic is pleased to be an equal employment opportunity employer.

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