Carle is seeking to hire a Clinical Research Quality Monitor who will be responsible for monitoring and evaluating research protocol and research compliance in clinical trials and investigator-initiated research within the Stephens Family Clinical Research Institute (SFCRI). This position will provide guidance in meeting the highest standards of regulatory guidelines governing clinical research. Duties include ensuring adherence to protocol and regulatory guidelines and the development and maintenance of compliance programs, as well as education and training of research staff and investigators.
Qualifications: EDUCATIONAL REQUIREMENTS MPH, or Masters in a health-related field. Ph.D., preferred
EXPERIENCE REQUIREMENTS Five (5) years human subjects experience in a clinical research environment and thorough knowledge of HIPAA regulations. Five (5) years working experience in a research compliance and regulatory environment; expertise, knowledge, and GCP experience in reviewing protocols and clinical trials, monitoring and evaluating internal processes, and proficiency in using electronic systems to manage clinical trial data or safety reporting.
OTHER REQUIREMENTS Thorough knowledge of ICH Guidelines, GCP's and FDA Code of Federal Regulations, other applicable regulatory authority laws and regulations, and institutional policies as they pertain to the conduct of protocol, research, and clinical trials requirements. Ability to accurately review and interpret protocols, grant applications, and clinical trial data. Strong written and verbal communication skills; the ability to communicate with all levels of physician, clinical, and research staff within SFCRI, as well as external investigators, in an accurate, helpful, and customer service oriented manner. Detail oriented, accurate, and able to solve problems pragmatically and assess risk.
Review research data for accuracy and completeness.
Participate in areas of clinical and research staff education, communication, and compliance policy development.
Identify and assess areas of research compliance risk for SFCRI.
Recommend and ensure appropriate corrective actions.
Provide written reports of research compliance activities and trends to department administration.
Review adherence to protocol and regulatory compliance in clinical trials and investigator-initiated research within SFCRI.
Conduct compliance assessments for accuracy and completeness; provide direct feedback to investigators and research coordinators to guide them in making necessary modifications to investigator-initiated SFCRI submissions in order to meet regulations.
Conduct special complex reviews of clinical trials and investigator-initiated research for allegations of noncompliance.
Monitor, validate, and evaluate data and trends to determine deficiencies and/or areas for further investigation; prepare written reports and provide recommendations to the appropriate department administrators, management, and others as needed within SFCRI.
Initiate and participate in the development and maintenance of compliance programs, educational/training materials, associated forms and policies; provide recommendations for process improvement.
Provide one-on-one and group training to research staff and investigators within SFCRI to ensure compliance with federal and state regulations and laws, GCP/CMS/FDA and other external regulatory agencies, and with internal research policies and procedures.
Maintain required knowledge of applicable regulations and sponsor-specific GCP and ensure changes in regulatory and institutional requirements are integrated in draft policies.
Develop databases, entering, tracking, and monitoring SFCRI submissions.
Supports other QA projects as needed.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
Internal Number: 5009
About Carle Foundation Hospital
Based in Urbana, IL, The Carle Foundation is a vertically integrated health system with more than 7,000 employees in its hospitals, physician group, health plan and associated healthcare operations.
Serving a population of over 1.4 million people across 41 counties in Illinois and five in Indiana, Carle provides patient-focused, world-class care with a dedication to research and education.
The 413-bed Carle Foundation Hospital is the region’s only Level I Trauma Center and offers Level III perinatal services. Carle ranked in 2018 as one of America’s 50 Best Hospitals by Healthgrades, a Best Hospital by U.S. News and World Report and has achieved Magnet® designation, the nation’s highest honor for nursing care. In addition, Carle secured Great Places to Work in Healthcare honors in 2018. The system also includes the 24-bed critical-access Carle Hoopeston Regional Health Center, the 134-bed Carle Richland Memorial Hospital, and Carle Physician Group with more than 500 doctors.
Carle’s Centers for Excellence include Mills Breast Cancer Institute, Carle Cancer Center, Carle Spine Institute, Carle Neuroscience Institute, Carle Digestive Health Institute and Carle Heart and Vasc...ular Institute. Carle Illinois College of Medicine is the world’s first engineering-based college of medicine. And the Stephens Family Clinical Research Institute enables clinicians and scientists to partner in solving some of today’s most pressing health issues.
Part of the Carle system, Health Alliance is a leading provider-driven health plan serving nearly a quarter-million members in Illinois, Iowa, Indiana, Ohio and Washington. In 2017, Health Alliance was awarded by J.D. Power for highest member satisfaction among commercial health plans in the Illinois and Indiana Region.