This position is responsible for providing regulatory guidance and regulatory management of clinical research protocol documents and activity from initial submission through study closure for clinical trials conducted in the Clinical Trials Office (CTO) of the Masonic Cancer Center. Incumbent at this level is an experienced professional competent to work at a high technical level.
Regulatory Management of Clinical Studies (100%)
Provides regulatory guidance and direction to all members of the research team in order to ensure compliance with federal regulations, good clinical practice as well as sponsor, University and CTO policies.
Serves as primary contact for purposes of collection and completion of required regulatory documentation.
In collaboration with the Principal 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 prequalification, site initiation, interim visits and closeout visits.
Serves as the regulatory subject matter expert through all phases of a clinical study.
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.
REQUIRED: Bachelor’s degree in health, public health, biomedical disciplines plus two years of work experience in research; or a combination of related education and work experience in research totaling six years. Experience with regulations governing research activity (such as GCPs, FDA regulations and ICH guidelines). Experience developing and working complicated project schedules. Computer proficiency in a PC environment including Microsoft Office products.
PREFERRED: Clinical Research Coordination certification. Experience in oncology clinical research setting. Previous professional experience on a clinical research project team or similar environment. Experience writing and adapting patient consent forms for research studies. Experience in an academic medicine setting.
Internal Number: 330890
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.