Reporting directly to the Manager, CR Monitoringthe SeniorClinical Research(CR) Monitor actively manages the daily operations of MSK's centralized Clinical Research Monitoring Program .
Manage and support the clinical research Risk-Based Monitoring (RBM) program for MSKs Investigator-Initiated Trial (IIT) portfolio.
Ensureadherence of the clinical research program at MSKto all federal regulatory requirements and ICH (International Councilfor Harmonization) guidance on Good Clinical Practice (GCP) through monitoring and oversight.
Ensure participantsare treated in accordance with the protocols.
Execute a real-time eligibility verification of participantsenrolled in MSK clinical trials through CTMS (Clinical Trials Management System).
Oversee the daily QA operational tasks of the Monitoring and Auditing Tracking System (MATS).
Work with QA Leadership to provide real-time feedback, process improvement and common trends identified through Monitoring to improve overall quality.
Supervise the day-to-day operations of staff including training, retention and performance management.
Bachelors Degree with at least 6 years of clinical research experience.
At least 2 years of management experience.
Human Subjects Protection Certification, GCP Certification, GMP Knowledge, FDA/EMA requirements, Quality Standards and Systems experience.
Communication Skills: The ability to develop, facilitate, and orchestrate effective communication with all members of MSK; responsible for the writing, preparing and educating staff on clinical research procedures and processes. Individual must be able to communicate effectively with all levels of staff including clinical staff (investigators, nurses etc), administration, research and clerical support staff, and Institutional Leaders as well as external sponsors. Excellent oral and written communication skills are required.
Federal Regulations: Must have an advanced comprehensive knowledge and understanding of the regulations pertaining to human research protection (including 21 CFR and 45 CFR 46 of the United States Code of Federal Regulations) and Health Insurance Portability and Accountability Act (HIPAA).
Information Management Skills: The ability to communicate, explain, interpret, share and present information to employees, management and clinical staff and patients at MSK as well as appropriate external contacts.
Analytical Skills: A strong ability and understanding on how to collect, analyze, interpret and prepare data for presentation (i.e., written, tabular and graphical formats). Excellent problem-solving ability. Ability to analyze situations, draws conclusions, make recommendations and convey information in a timely and proficient manner. Strategic thinker.
Time Management Skills: The ability to set priorities among several tasks simultaneously and meet established deadlines. Ability to manage multiple large scale development projects simultaneously. Ability to guide staff to ensure programmatic activities adhere to established time frames and deadlines.
Administrative Skills: The ability to plan, organize, facilitate and lead meetings, to develop programs, to manage research projects and to prioritize work across several services/departments is essential.
Computer Skills: Proficiency in use of computers and software such as database management, spreadsheet, word processing and graphics applications. Knowledge of mainframe systems utilized at MSKCC is essential. #LI-POST
Internal Number: 2019-37940
About Memorial Sloan-Kettering Cancer Center
As one of the world's premier cancer centers, Memorial Sloan-Kettering Cancer Center is committed to exceptional patient care, leading-edge research, and superb educational programs. The close collaboration between our physicians and scientists is one of our unique strengths, enabling us to provide patients with the best care available today as we work to discover more effective strategies to prevent, control, and ultimately cure cancer in the future. Our education programs train future physicians and scientists, and the knowledge and experience they gain at Memorial Sloan-Kettering has an impact on cancer treatment and the biomedical research agenda around the world.