We are seeking a Clinical Research Supervisor (CRS) for our dynamic team in the Multiple Myeloma service in the Department of Medicine . As an integral member of the research team and in compliance with all regulatory, institutional, and departmental requirements, the CRS supervises the day-to-day activities of Clinical Research Coordinators (CRSs) and Clinical Research Associates (CRAs) to ensure efficient and effective operations. Responsible for data management activities and for data integrity associated with clinical research. Participates in special projects and task forces as determined by management. The Clinical Research Supervisor will manage several research protocols, including investigator initiative trials, industry-sponsored studies, as well as bio-specimen protocols.
Staff Management and Development - You will participate in the orientation, training and supervision of Clinical Research Coordinators; participate in facilitating departmental trainings; align staff and resources with appropriate protocols and research needs; and maintain workflow consistency amongst staff with standardized processes.
Operation Management - You will ensure that workflow is managed and monitored to meet departmental and service needs; assist the Clinical Research Manager (CRM) with protocol activation, especially with start-up activities; monitor research portfolio for workload by appropriately managing and identifying service needs.
Quality Assurance - You will perform regular audits to ensure that the data collected is complete and accurate, and to ensure that the research project is carried out as planned. You will also participate in the Institutional quality assurance audits.
Regulatory Compliance - You will ensures that all appropriate Institutional, State, and Federal regulations are followed throughout the course of a research project, database, or protocol. Also, you will ensure that research protocols are approved by the Institutional Review Board/Privacy Board (IRB/PB) and followed as written.
Data collection - You will utilizes appropriate methodologies to collect patient/human subject information for research projects, databases, and/or protocols.
Data reporting - You will generate reports to all necessary parties (institutional and federal) on the progress of the research project, database, or protocol. You will prepare data for analysis, monitoring visits and audits.
Clinical Research Billing Management - You will implement Principal Investigator's decisions regarding Patient-Care Costs (both billable and non-billable), and ensures that research non-billable services are not billed to patients/human subjects or insurers. Also, you will assist manager with billing reconciliation.
Special Projects - You will participate or coordinate on both interdepartmental and intra-departmental organization-wide research projects as requested. You will provide leadership, organizational, creative, or clerical support to established and new research initiatives.
At least 2-4 years of relevant (clinical research) experience, or as determined by hiring manager.
At least one year's supervisory experience strongly preferred.
Experience with Industrial protocols strongly preferred.
Comprehensive knowledge and understanding of the regulations pertaining to human subject protection (including 21 CFR and 45 CFR 46 of the United States Code of Federal Regulations) and Health Insurance Portability and Accountability Act (HIPAA) is critical.
Strong interpersonal, verbal and written communication skills. Ability to form strong and constructive internal as well as external professional relationships.
Effectively interacts with and collaborates at all levels in the organization.
Experience in collaboration with relevant vendors, CROs and sponsors.
Strong attention to detail & excellent organizational skills.
Strong time management/project management skills.
Strong presentation skills.
Knowledge of oncology-specific terminology is helpful.
Experience in the use of various electronic data management systems. Strong Data management skills, including database design preferred.
Basic knowledge of Microsoft suite (PowerPoint, Word, Access, Excel) and Teamshare. #LI-POST
Internal Number: 2020-39113
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.