Summary

The Dan L. Duncan Comprehensive Cancer Center (DLDCCC) has an immediate opening for a Regulatory Affairs Specialist.  The Regulatory Affairs Specialist, as a member of the Clinical Trials Support Unit of the DLDCCC, works to provide regulatory support and Investigator Site File maintenance 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, maintaining physical and/or electronic regulatory records for existing and future clinical trials and assisting investigators and study staff with interpreting local, federal and international clinical research regulations.

This position will support a busy, diverse and rapidly growing group of research investigators in the Gastrointestinal Oncology Disease Working Group.  He or she will be responsible for the regulatory oversight and maintenance of existing clinical trials within the GI portfolio and will have a direct and significant impact on the clinical research operational structure of the Cancer Center and directly contribute to the overall research mission of the College.  The ideal candidate would be able to integrate with the existing team and offer immediate support (after an appropriate training/oversight period) to keep operations running smoothly.  The selected candidate will be entrusted with proprietary research information, such as clinical trial protocols, drug brochures and research data.  As such, it is important that the individual be appreciative of the confidential nature of many of the tasks and duties assigned to them.

This position is currently Hybrid.

Job Duties

• Prepare clinical trial submission for review.
• Responsible for preparing amendments, continuing reviews and other maintenance-phase related submissions for assigned clinical trials, ensuring adherence with internal timelines and when applicable, external deadlines (e.g. approval expiration dates) through the use of various online research interface portals.  
• Attend assigned Disease Working Group Meetings and provide updates regarding on-going research.
• Maintain protocol/site regulatory files.
• Receive and maintain site regulatory files of assigned clinical trials following the completion of start-up activities.  
• Maintain files through the use of electronic regulatory software and keep necessary data current in the Clinical Trials Management System database by following departmental best practices.  
• Provide regulatory guidance to investigators and other study staff members.
• Fulfill the role of subject matter expert with regard to regulatory compliance; 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.
   

Minimum Qualifications

• High School diploma or GED.
• Four years of relevant experience.

Preferred Qualifications

• Must have strong communication skills (oral and written), above-average computer skills and proficiency, ability to multi-task and high attention to detail. 
• Work independently and as part of a team unit; must possess the interpersonal skills necessary to work productively with a variety of internal and external stakeholders, such as industry sponsors/their representatives, clinicians, staff and co-workers within the department.
• Four (4) years of relevant experience in clinical research, preferably from a regulatory or administrative role. 
• Must be able to manage competing priorities, deadlines and projects while maintaining a high quality work product through supporting regulatory maintenance of active oncology clinical trials within an NCI-designated comprehensive cancer center housed within the BCM academic medical center matrix.
• Must be sufficiently computer-literate and possess the necessary organizational skills and attention to detail to learn and master the functionality and workflow processes required to maintain electronic regulatory documentation in a Part-11 compliant system.  Modernization and maximizing efficiency of processes is a key component to supporting the Cancer Center Support Grant.