Sr. Regulatory Analyst

University of Miami Miller School of Medicine
Sylvester Comprehensive Cancer Center



The Sylvester Comprehensive Cancer Center is seeking a Sr. Regulatory Analyst. Serve as the main point of contact / liaison for cross functional teams ensuring that studies follow the clinical trial activation process in an expedited manner. Serve as a research concierge for new SCCC investigators who are submitting their first study as well as service users. Communicate with each group involved in study activation including the Protocol Development Office, Study Start Up team, the Protocol Review Committee, the Study Intake Team, the CRS Managers, the SCCC Office of Clinical Trial Finances and the SCCC Office of Research Compliance. Evaluate whether these groups are meeting and/or exceeding expected project timelines/deadlines. Track and divulgate the activation status of the SCCC clinical trials pipeline portfolio. Assist in identifying, compiling and addressing roadblocks to quick trial activation. Notify the Director, Research Committees and Clinical Research Leadership of any issues that could affect the clinical trial activation success and/or broad patterns of inefficient operations. Attend Site Disease Group and CRS Management meetings, reporting and updating on the trial activation status and possible delays. Propose and discuss actions to expedite activation of trials and remain in constant communication with the Principal Investigator (PI) to inform him/her of current progress. Assist with the preparation and periodic review of processes and Standard Operating Procedures pertinent to the scope of work assigned. Complies with U.S Food and Drug Administration (FDA) regulations, Good Clinical Practices. (GCP), International Conference on Harmonization (ICH) guidelines, and sponsor internal/external policies and procedures. Provides administrative support for ongoing projects, as assigned. Serve as the main point of contact/liaison for all Feasibility matters. Communicate with each partner involved in the Feasibility Committee to ensure that timelines/deadlines are met and all reviews are done in parallel to PRC submission and review. Assist in identifying, compiling and addressing roadblocks to not being able to accept vital trials at SCCC (main campus and satellites). Notify the Director, Research Committees and Clinical Research Leadership of any issues that could affect the clinical trial success and/or broad patterns of inefficient operations. Attend Site Disease Group meetings. Assist with the preparation and periodic review of processes and Standard Operating Procedures pertinent to the scope of work assigned. Complies with U.S Food and Drug Administration (FDA) regulations, Good Clinical Practices (GCP), International Conference on Harmonization (ICH) guidelines, and sponsor internal/external policies and procedures. Provides administrative support for ongoing projects, as assigned.

Apply online at: um.hodesiq.com