Summary

The Dan L. Duncan Comprehensive Cancer Center (DLDCCC) has an immediate opening for a Regulatory Affairs Associate. The Regulatory Affairs Associate, as a member of the Clinical Trials Support Unit of the DLDCCC, works to provide regulatory compliance and study start-up support to physician investigators in one or more designated oncology disease areas. This support includes, but is not limited to preparing clinical trial submissions for review by internal and external regulatory agencies and oversight bodies, shepherding trials through the local approval process and providing guidance from a regulatory perspective to investigators and study staff.

Employees with Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) are eligible for certification pay.

This position offers the flexibility of a hybrid work arrangement.

Job Duties

• Prepares clinical trial submission for review. (40%)
• Prepares all initial, amendment and continuing review submissions for assigned clinical trials, ensuring adherence with internal timelines and any external deadlines (e.g. approval expiration dates) through the Maintains protocol/site regulatory files. (30%)
• Creates and maintains the site regulatory files for assigned clinical trials by entering the necessary approvals and metrics into the Clinical Trials Management System and following the internal best practices and timelines for electronic filing of essential regulatory documents as well as compliant maintenance of physical documents.
• Provides regulatory guidance to investigators and other study staff members. (30%)
• Acts as a subject matter expert with regard to regulatory compliance and be able to apply knowledge of current research regulations (FDA, ICH/GCP, local affiliate rules) to commonly encountered situations in the conduct of clinical research in an academic setting.
• Performs other job related duties as assigned.

Minimum Qualifications

• Bachelor's degree.
• Two years of relevant experience.

Preferred Qualifications

• Experience in clinical research, preferably from a regulatory or administrative role.  
• Certification as a Research Professional (SOCRA or ACRP certified) is preferred, but not required.
• Knowledge and familiarity with clinical research compliance and regulations, including FDA, OHRP and ICH/GCP.  
• Must have excellent oral and written communication skills, ability to multi-task and high attention to detail.