Job Abstract

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 country. 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. 

As a Research Regulatory QA Coordinator, you will implement and maintain the Research Regulatory and Quality Assurance (QA) Program including QA auditing, monitoring and training. This position provides support for research infrastructure. A dynamic position offering the highest quality of care for our innovative research program.

The Future Caregiver is someone who: 

• Has High-level management and leadership skills. 
• Can schedule and manage tasks effectively. 
• Is experience with conflict resolution and problem-solving. 
• Has written and verbal communication skills. 
• Has teamwork and motivational skills. 

This is a rewarding opportunity that offers growth-oriented projects, mentorship, support, and resources. You will experience great exposure to both the institute and department leadership and have numerous opportunities for career growth in different administrative and project/program management.  

At Cleveland Clinic, we know what matters most. That's why we treat our caregivers as if they are our own family, and we are always creating ways to be there for you. Here, you'll find that we offer: resources to learn and grow, a fulfilling career for everyone, and comprehensive benefits that invest in your health, your physical and mental well-being and your future. When you join Cleveland Clinic, you'll be part of a supportive caregiver family that will be united in shared values and purpose to fulfill our promise of being the best place to receive care and the best place to work in healthcare.

Job Description:

• Assists with establishment of standard operating policies, procedures and guidelines for the conduct of research that are in alignment with GCPs, external regulatory agencies and central research administration offices.
• Coordinates all regulatory and research compliance quality audits and inspections which includes billing and non-billing.
• Identifies, reports and assists PI in the resolution of compliance issues/concerns.
• Reports into the Institute and Research Compliance database per requirements.
• Participates in the evaluation of research industry best practices for research compliance and quality assurance to develop metrics and drive improvement.
• Provides education as needed. Maintains records, files and data for research regulatory and quality assurance efforts.
• Other duties as assigned.

Education:

• Bachelor's Degree in healthcare, quality management or a related discipline preferred.

Certifications:

• 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.

Competencies (Complexity of Work):

• Requires critical thinking skills, decisive judgment and the ability to work with minimal supervision. Must be able to work in a stressful environment and take appropriate action.

Work Experience:

• Minimum five years research experience with a focus on research quality assurance and compliance required.
• Research experience coordinating regulated research projects preferred.
• Bachelor's degree in healthcare or science field may offset two years of research experience requirement.

Preferred Qualifications:

• Five years of research experience with a focus on research quality assurance and compliance. Requires clinical, human subject research over basic science research. Research experience coordinating  FDA regulated research projects preferred.

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
• Ability to move up to 25 pounds
• May be required to work with biological, chemical and radiation hazards after proper training

Personal Protective Equipment:

• Follows 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 tobacco free and drug free environment. All offers of employment are followed by testing for controlled substance and nicotine. All offers of employment are follwed by testing for controlled substances and nicotine. All new caregivers must clear a nicotine test within their 90-day new hire period. Candidates for employment who are impacted by Cleveland Clinic Health System's Smoking Policy will be permitted to reapply for open positions after one year.

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. 

Please review the Equal Employment Opportunity poster. 

Cleveland Clinic Health System is pleased to be an equal employment employer: Women / Minorities / Veterans / Individuals with Disabilities