Supervise regulatory personnel, and responsible for overseeing daily operations, quality and timeliness of regulatory activities.
Locations (16)
Wisconsin, United States
Alabama, United States
Arizona, United States
Delaware, United States
Florida, United States
Georgia, United States
Show all 16 locations
Illinois, United States
Indiana, United States
Maryland, United States
Michigan, United States
Minnesota, United States
Missouri, United States
Compensation
Target salary range for this position is between $75,300.00 and $95,900.00 annually.
Responsibilities
Supervise staff including overseeing daily operations of the regulatory team to ensure compliance with state and federal regulations
Develop, improve, and apply standard education, processes, and procedures requiring specialized experience to assure timely, quality, and compliant work
Ensure creation and maintenance of accurate, timely and compliant regulatory records and data
Operationalize and implement proposed solutions or process improvements related to identified problems or obstacles in the system/procedures related to implementation of the research protocols
Draft, submit, and advise on regulatory submissions including but not limited to protocols, protocol summaries, amendments, protocol deviations, serious adverse and other reportable events, continuing progress reports, and consent-to-treat documents without need for supervision
Quality Control Coordinator 1 interfaces with clinical research faculty and staff to execute and maintain a comprehensive cancer clinical research quality control program across LCCC’s NCI Cancer Center Support Grant consortium sites.
Compensation
$44,022.00 - $73,406.80
Responsibilities
Performing quality control assessments and risk-based centralized eligibility reviews for select cancer clinical trials
Conducting regular quality reviews within the Clinical Trials Management System (CTMS; OnCore) to assure data integrity and SOP compliance
Assisting in the coordination, preparation, conduct, and follow-up for internal quality monitoring and external audits across LCCC consortium sites
Collaborating with ORQA and the TEQC Manager to review audit findings and identify systemic trends to inform future training and educational initiatives
Assisting with the maintenance of Lombardi CTO Standard Operating Procedures and Guidance Documents to support uniform research practices
Requirements
Bachelor’s degree in a biological science, health science, or related field
Nice to have: Up to two years of clinical research experience, preferably in oncology clinical trials
Nice to have: Knowledge of NCI Cancer Center Support Grant guidelines