Seattle Cancer Care Alliance brings together the leading research teams and cancer specialists of Fred Hutch, Seattle Children's, and UW Medicine. One extraordinary group whose sole mission is the pursuit of better, longer, richer lives for our patients.
Manages the regulatory affairs for the SCCA Research Integration (RI) Program to ensure that the clinical trials initiated and/or maintained by RI are conducted in compliance with the clinical trial protocol as well as all applicable state and federal regulations. Overall responsibilities for ensuring RI trials meet regulatory requirements and are compliant with federal institutional policies. This is critical for ensuring the quality of the research, the reputation of the institution, and patient safety. Oversees regulatory policies, processes and staff for the SCCA Research Integration Program including credentialing, regulatory documentation, quality assurance and protocol compliance monitoring. Co-leads oversight of SCCA’s Human Research Protection (HRP) program and efforts to ensure that SCCA continually provides a safe and compliant environment for the conduct of human subject research. Oversees SCCA’s Protocol Compliance Monitoring program and staff to ensure that SCCA meets its commitment to timely assessment and implementation of preventative actions to achieve and maintain protocol compliance. Oversees the coordination and management of Research Integration’s QA activities associated with industry sponsored, investigator initiated and NCTN clinical research studies that include, but are not limited to, the review of all trial-related activities and documents to assure compliance with the protocol plan, internal policies, standard operating procedures (SOPs), good clinical practices (GCPs) and all other relevant regulations. Assesses staffing needs, hiring and retaining high-quality staff, completing performance evaluations in a timely fashion, taking disciplinary actions when needed, and handling the day-to-day human resources functions of the team.
Reports to the Associate Director of Research Integration and in close collaboration with the Director of Research Integration. Also works closely with other Research Integration Managers, Principal Investigators, UW/FH Research Managers, coordinators, clinical operations staff and all SCCA/FH/UW staff. Must have the flexibility and managerial commitment to work collaboratively with all study sponsors, SCCA partners and external stakeholders as applicable.
KEY KNOWLEDGE SKILLS AND ABILITIES
Minimum Leadership Experience:
Other Key Skills and Abilities: