Are you committed to the protection of human research participants? Are you passionate about working in clinical trials and ready to take on more responsibility and ownership? The Human Research Protection Program (HRPP) team is seeking an HRPP Operations Manager to oversee several aspects within HRPP space. The HRPP team is service based and is responsible for protecting the rights and welfare of human research participants in accordance with the federal regulations and internal operating procedures.
Provide oversight of the review and management of all Serious Adverse Events (SAEs) and safety-related submissions to HRPP
Maintain systems for the efficient input, throughput, and output of SAEs and safety related correspondence
Serve as a liaison to research teams and investigators to ensure SAE and safety submissions are being carried out in accordance with institutional SOPs and federal regulations
Identifies problems, trends and issues related to HRPP operations requiring further action or review by the IRB/PB Chairs, HRPP Director, and/or IRB Administrators. Play a role in developing and carrying out appropriate action plans to correct issues.
Serve as the Administrator to the Genomic Advisory Panel (GAP), a subcommittee to the IRB
Assists the HRPP Administrator with Operations based responsibilities, when needed.
Trouble-shoots all system related problems with PIMS development team in IS and HRPP office staff. Tracks problems reported and monitors until resolutions are complete. Participates in design enhancements as required.
Prepare data reports for IRB Chairs, IRB/PB membership, CRA senior management, institutional leadership and hospital administrative staff, as needed.
Capable of anticipating and balancing the needs of multiple stakeholders.
A good decision-maker, with proven success at making timely decisions that keep the organization moving forward.
Focused on continuous improvement, knowing the most effective and efficient processes to optimize work flow.
Adept at planning and prioritizing work to meet commitments aligned with organizational goals.
An effective communicator, capable of determining how best to reach different audiences and executing communications based on that understanding.
Have a firm understanding of clinical research space (i.e. SAEs, IRB SOPs, consent requirements, etc.)
A Bachelor's degree (preferred) with a minimum of 1 year of clinical research experience. In lieu of a Bachelor's, 5 years of direct experience will be accepted.
Knowledge of State and Federal HHS regulations regarding human subject protection (45 CFR 46), the HIPAA Privacy Rule (45CFR 160,164), the FDA (21 CFR 50, 21 CFR 56)
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 28th 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 2018, as well as one of Glassdoor’s Employees’ Choice Best Place to Work for 2018. We’re treating cancer, one patient at a time. Join us and make a difference every day.