At Memorial Sloan Kettering (MSK), we're not only changing the way we treat cancer, but also the way the world thinks about it. By working together and pushing forward with innovation and discovery, we're driving excellence and improving outcomes.
For the 27th year, MSK has been named a top hospital for cancer by U.S. News & World Report. We are proud to be on Becker's Healthcare list as one of the 150 Great Places to Work in Healthcare in 2016, as well as Glassdoor's annual Employees' Choice Awards 2017. We're treating cancer, one patient at a time. Join us and make a difference every day.
As an integral member of the research team and in compliance with all regulatory, institutional, and departmental requirements, the Clinical Research Supervisor supervises the day-to-day activities of 6-10 Research Study Assistants in the Lymphoma Service for the Department of Medicine , ensuring 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 biospecimen protocols.
Responsibilities include :
Staff Management and Development - Participates in the orientation, training and supervision of Research Study Assistants. Participates in facilitating departmental trainings. Aligns staff and resources with appropriate protocols and research needs. Maintains workflow consistency amongst staff with standardized processes.
Operation Management - Ensures that workflow is managed and monitored to meet departmental and service needs. Assists Clinical Research Manager with protocol activation, especially with start-up activities. Monitors research portfolio for workload by appropriately managing and identifying service needs.
Quality Assurance - Performs regular audits to ensure that the data collected is complete and accurate and to ensure that the research project was carried out as outlined. Participates in the Institutional quality assurance audits.
Regulatory Compliance - Ensures that all appropriate Institutional, State, and Federal regulations are followed throughout the course of a research project, database, or protocol. Ensures that research protocols are approved by the Institutional Review Board/Privacy Board (IRB/PB) and followed as written.
Data collection - Utilizes appropriate methodologies to collect patient/human subject information for research projects, databases, and/or protocols.
Data reporting - Generates reports to all necessary parties (institutional and federal) on the progress of the research project, database, or protocol. Prepares data for analysis, monitoring visits and audits.
Clinical Research Billing Management - Implements 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. Assist manager with billing reconciliation.
Special Projects - Participates or coordinates on both interdepartmental and intradepartmental organization-wide research projects as requested. Provides leadership, organizational, creative, or clerical support to established and new research initiatives.
At least 3 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.
Must have a 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).
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.
Detail-oriented, excellent organizational skills.
Strong time management/project management skills.
Strong presentation skills.
Knowledge of oncology specific terminology is preferred.
Experience in the use of various electronic data management systems. Strong Data management skills, including database design preferred.
Basic knowledge of Microsoft suite (Power Point, Word, Access, Excel) and Teamshare.
MSK is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sexual orientation, national origin, age, religion, creed, disability, veteran status or any other factor which cannot lawfully be used as a basis for an employment decision.
Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.
As one of the world's premier cancer centers, Memorial Sloan-Kettering Cancer Center is committed to exceptional patient care, leading-edge research, a...nd 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.