Regulatory Specialist

PURPOSE 

Under the administration of the Director of Regulatory Affairs, the Regulatory Specialist will contribute to the support of breast and colorectal cancer research and the management of clinical trials by preparing and coordinating protocol-related regulatory documents for new and existing Federal and Industry sponsored clinical trials and serving as a resource to staff and member institutions.   

ESSENTIAL FUNCTIONS

Regulatory Submissions and Protocol Maintenance

• Prepares documents including but not limited to drug applications, protocols, amendments, progress reports, safety report information for submission to applicable government agencies and Institutional Review Boards (IRBs) for obtaining approvals required to initiate and conduct clinical trials.  Maintains protocol-related registries.
• Serves as a regulatory resource to member institutions, pharmaceutical partners and NSABP staff.   Provides support to the protocol development team and sites by reviewing informed consent forms.   
• Prepares instructional memoranda for investigators regarding protocol activations, amendments, notifications, and closures.  Develops tools and, when needed, conducts training presentations to educate site staff about regulatory issues related to oncology trials.  
• Provides support to the Scientific Publications team by submitting abstracts and manuscripts to applicable government agencies and pharmaceutical partners per contractual obligations.

OTHER RESPONSIBILITIES

• Maintains professional knowledge by reviewing professional publications, attending professional meetings, and establishing personal networks.  Able to travel to offsite meetings
   as required.  
• Understands and adheres to the policies, procedures, regulations, and practices necessary to conduct the normal function of this position.
• Maintains confidentiality and performs duties in a responsible and ethical manner.
• Performs additional duties as may be assigned.

EXPERIENCE/SKILLS

• Bachelor's degree required, preferably in the sciences.  Advanced degree or equivalent experience preferred.
• Minimum of 2 years of regulatory clinical trial experience within the clinical research environment.  
• Familiarity with Federal regulations and Good Clinical Practice principles.
• Sound written and verbal communication skills. 
• Open, honest team member approach/skills.
• Ability to manage multiple projects and to meet tight deadlines.
• Ability to coordinate and prioritize tasks and complete in a timely manner. 
• Strong attention to detail with high level of accuracy.  
• Ability to participate as a team member and work independently within established guidelines. 

The NSABP Foundation, Inc. is an Equal Employment Opportunity and Affirmative Action Employer committed to the value of workforce diversity. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, gender identity, national origin, physical or mental disability, protected veterans, genetic information, and sexual orientation.