Research Regulatory QA Coordinator- Neurological Institute

4 weeks ago


Cleveland, United States Cleveland Clinic Full time

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 petencies (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.Requiresclinical, human subject research over basic science research. Research experience coordinatingFDAregulated research projects preferred.Physical Requirements: Ability to perform work in a stationary position for extended periodsAbility to operate a computer and other office equipmentAbility to communicate and exchange accurate informationAbility to move up to 25 poundsMay be required to work with biological, chemical and radiation hazards after proper trainingPersonal Protective Equipment: Follows standard precautions using personal protective equipment as required.Pay RangeMinimum hourly: $27.65Maximum hourly: $42.17The pay range displayed on this job posting reflects the anticipated range for new hires. While the pay range is displayed as an hourly rate, Cleveland Clinic recruiters will clarify whether the compensation is hourly or salary. A successful candidate's actual compensation will be determined after taking factors into consideration such as the candidate's work history, experience, skill set, and education. This is not inclusive of the value of Cleveland Clinic's benefits package, which includes among other benefits, healthcare/dental/vision and retirement.



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