Cancer Research Quality Specialist

At Cleveland Clinic Health System, we believe in a better future for healthcare. And each of us is responsible for honoring our commitment to excellence, pushing the boundaries and transforming the patient experience, every day. We all have the power to help, heal and change lives — beginning with our own. That’s the power of the Cleveland Clinic Health System team, and The Power of Every One. Job Title Cancer Research Quality Specialist Location Cleveland Facility Cleveland Clinic Main Campus Department Research Administration-Research Innov and Educ Job Code T97582 Shift Days Schedule 8:00am-5:00pm Job Summary Job Details 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. Cleveland Clinic Cancer Center provides complete cancer care enhanced by internationally recognized research efforts, offering the most effective techniques to achieve long-term survival and improve patients’ quality of life. As a Cancer Research Quality Specialist, you will implement and maintain the quality and compliance of cancer clinical research in accordance with regulations from applicable regulatory authorities and the Case Comprehensive Cancer Center (CCCC) grant requirements. In this role, you will plan, schedule, and conduct post-approval monitoring activities for cancer studies. A caregiver in this role works a hybrid schedule from 8:00 a.m. – 5:00 p.m., with one day in the office and four days remote. A caregiver who excels in this role will: Oversee Cancer Institute auditing, monitoring and training for assigned areas. Coordinate all regulatory and quality audits and inspections, identifying and resolving compliance issues and concerns, developing and implementing quality improvement plans, defining standard scope of audit to mitigate future risk and reporting on research compliance activities. Plan, schedule, and conduct post approval monitoring activities for Cancer studies. Support the development and implementation of standard operating procedures (SOPs), guidelines, and policies for clinical research in alignment with GCP, institutional, regulatory, and Cancer Center standards. Support committees as applicable to uphold the CCCC grant requirements. Conduct and report on audits related to CCCC metrics to ensure compliance with CCCC. Identify potential compliance issues, escalate concerns appropriately, and collaborate with PIs to ensure timely resolution. Ensure timely reporting to institutional and research compliance offices in accordance with established requirements. Contribute to the evaluation and integration of cancer research best practices to strengthen compliance and performance metrics. Oversee Cancer Institute auditing, monitoring and training. Other duties as assigned. Minimum qualifications for the ideal future caregiver include: Bachelor's degree from an accredited college or university and five years recent experience in clinical trials research OR Advanced degree in healthcare or science field and three years recent experience in clinical trials research OR Associate degree and seven years of relevant experience OR High School Diploma and nine 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 with ability to apply laws and regulations within healthcare operations Preferred qualifications for the ideal future caregiver include: 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) 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 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 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.