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. **Pay Range** Minimum Annual Salary: $63,250.00 Maximum Annual Salary: $96,467.50 The pay range displayed on this job posting reflects the anticipated range for new hires. 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. The pay range displayed does not include any applicable pay practices (e.g., shift differentials, overtime, etc.). The pay range does not include the value of Cleveland Clinic's benefits package (e.g., healthcare, dental and vision benefits, retirement savings account contributions, etc.). Cleveland Clinic Health System is pleased to be an equal employment employer: Women / Minorities / Veterans / Individuals with Disabilities