We are seeking a Clinical Research Supervisor (CRS) to join our dynamic Regional Care Network overseeing the team at MSK Monmouth. As a CRS, you will supervise the day-to-day activities of ~7 Clinical Research Specialists to ensure efficient and effective operations. You will be responsible for data management activities and for data integrity associated with clinical research for the Regionals. You will also participate in special projects and task forces as determined by management.
Work with a Clinical Research Manager to oversee the regional division clinical research portfolio including prospective clinical trials and retrospective waiver projects.
Collaborate with clinical teams to coordinate research activities across multiple locations, according to institutional and other governing policies.
Implement all aspects of research protocols/ projects from study start up to study closure.
Direct staff management and development of Clinical Research Specialists (CRSp).
Implement standards for clinic and study management, and policies and procedures to meet those standards to ensure the highest quality management of research projects and databases.
Generate reports (e.g., DSMC, toxicities, minimal data set, CPR) and perform advanced queries for Principal Investigators, the IRB, sponsoring agencies, and management.
Oversee data management aspects of research databases such as the Clinical Research Database (CRDB) and other external EDCs.
Conduct systematic audits of research studies and/or databases to ensure that data collected has no typographical errors, is consistent with source documents, and is in compliance with external sponsor/regulatory requirements.
Review regulatory submissions as necessary.
Facilitate weekly team meetings and other PI/ service-specific meetings as needed.
Participate in the orientation, training and supervision of CRSps; participate in facilitating departmental trainings; align staff and resources with appropriate protocols and research needs; and maintain workflow consistency amongst staff with standardized processes.
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.
Perform regular audits to ensure that the data collected is complete and accurate, and that the research project is carried out as planned.
Ensure 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.
Utilize appropriate methodologies to collect patient/human subject information for research projects, databases, and/or protocols.
Generate reports to all necessary parties (institutional and federal) on the progress. You will prepare data for analysis, monitoring visits and audits.
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.
Effective at building formal and informal networks inside and outside the organization to further departmental and institutional goals.
Adept at building partnerships and working collaboratively with others to meet shared objectives and goals.
A good decision-maker, with shown success at making timely decisions that keep the organization moving forward.
Eager to foster talent and support people in meeting their career goals and the organization's goals.
A bachelor's degree with at least 3 years of clinical research experience OR a high school diploma with 6 years of clinical research experience
Supervisory experience and experience with high volume trials is 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 time management/project management 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.
Internal Number: 2019-36906
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.