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 10-11 Research Study Assistants for the Urology, Pediatric, Colorectal and Plastic Services,
within the Department of Surgery
, ensuring efficient and effective operations. Responsible for data management activities and for data integrity associated with clinical research as well as staff management and overseeing the opening of new studies within the respective services. Participates in special projects and task forces as determined by management. The Clinical Research Supervisor will manage several research protocols, including multi centered trials, NCTN protocols, industry sponsored studies, chemotherapy , device, surgery-based studies, as well as biospecimen protocols.
Staff Management and Development - Participates in the orientation, training and supervision of Research Study Assistants and a RSS. 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 device, NCTN and 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 oral and written communication skills.
Knowledge of oncology specific terminology is preferred.
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.