Duties: Responsible for providing technical expertise and overall management of clinical research protocol documents and activity from initial submission through study closure. Incumbent at this level is an experienced professional competent to work at the highest technical level.
-Provides regulatory guidance and direction to all members of the research team in order to ensure compliance with all applicable policies, procedures and regulations. -Serves as primary contact for purposes of collection and completion of required regulatory documentation. -In collaboration with the Principle Investigator, interprets protocols and creates consent documents needed for clinical research study. -Prepares regulatory approval applications, respond to stipulations, and shepherd applications and correspondence through the processes until approvals are obtained. -Track all regulatory review submissions and approvals to ensure deadlines are met. -Maintain regulatory documentation to ensure compliance and audit-ready at any given time. -Coordinates the processing of outside safety reports and local serious adverse events. -Reports unanticipated problems involving risk to subjects or others (UPIRTSO) within the required timeline. -In collaboration with research team, provides support and oversees visits with outside sponsors, which may include pre-qualification, site initiation, interim visits and close-out visits. -Initiates and leads special projects, to include process improvement and regulatory training. -Serves as the regulatory subject matter expert through all phases of a clinical study. -Serves as a lead and mentor to other clinical research staff, to include the execution of new initiatives and process improvement. -Lead regulatory educational events for clinical research staff. -Develops protocols with the Principle Investigator and provides recommendations on research plan. -Coordinates and facilitates the submission of Investigational New Drug (IND) and/or Investigational Device Exemption (IDE) applications.
All required qualifications must be documented on application materials.
-BA/BS plus at least 4 years of clinical research experience or advanced degree plus 2 years of experience or a combination of related education and work experience to equal eight years -Previous experience working as a Regulatory Specialist -Experience with regulations governing research activity (such as GCP's, FDA regulations and ICH guidelines). -Experience developing and working complicated project schedules. -Computer proficiency in a PC environment including Microsoft Office products
-Experience in oncology clinical research setting and in an academic medicine setting. -Clinical Research Coordinator certification.
Internal Number: 327299
About University of Minnesota, Twin Cities
The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.