The goal of the Clinical Research Strategic Partnerships Office at MSK is to expand access at community based hospitals to MSK clinical trials and cutting-edge cancer research that raises the standard of care. We are seeking to hire a Research Project Associate (RPA) to join our team in supporting MSKs Clinical Research Strategic Partnerships Program and Alliance Program (Hartford Healthcare, Lehigh Valley Health Network, Miami Cancer Institute and Norwalk Hospital) .This is an exciting opportunity to join the Clinical Research Strategic Partnerships Office working with regulatory compliance, protocol management, and program quality/monitoring.
Regulatory Compliance of Strategic Partners
Maintaining Strategic Partners regulatory binders to ensure documentation is complete and accurate
Facilitating submission and finalization of SAEs, Safety Reports and Deviations between MSK and Strategic Partners to the IRB and Sponsors
Management and coordination of amendments, consent translations, amendment document distribution and notification via Strategic Partnerships Web Portal
Serve as the MSK point of contact for CR Strategic Partnership and Alliance sites in activities related to the clinical trial and maintain real-time knowledge of all aspects of the trial, including data management, subject management and regulatory oversight.
Perform diverse administrative and research-related duties requiring good judgment, comprehensive understanding of all federal regulatory standards and ICH (International Center for Harmonization) mentorship on Good Clinical Practice (GCP) and MSK CRA SOPs.
Ensure that participants are treated in accordance with the protocols and that study conduct is in accordance with the CR protocol and applicable policies and regulations.
Participates in internal/external clinical trial meetings to update the study team/external sites with relevant information related to the clinical trial.
Conduct real-time eligibility verification and risk-based monitoring (RBM) of external participants enrolled in MSK clinical trial
Performs regular monitoring to ensure study is being carried out according to the protocol and MSK IRB SOPs
Protocol Tracking and Quality Monitoring Support
Collaboration with MSK Clinical Research Service Teams and Strategic Partner Teams
Participate in special projects and task forces as determined by management.
Bachelors degree preferred with experience in clinical research and/or other applicable research investigation. Relevant graduate work considered in lieu of minimum experience.
At least 1-3 years of clinical research experience
Comprehensive knowledge and understanding of the regulations pertaining to human subject protection, Good Clinical Practice and other clinical research essential.
Detail-oriented, strong written and verbal communication, ability to multitask, and excellent time management skills strongly preferred.
Adept at building partnerships and working reciprocally with others to meet shared objectives and goals
Ability to solve problems by using a logical, systematic, sequential approach.
Internal Number: 2020-43786
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.