Regulatory Specialist 1

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. 

Responsibilities/duties:

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.