Regulatory Compliance Specialist

Description:
Incumbent is independently responsible for IRB study protocols under the supervision of the PI and their related colleagues. Responsibilities will include coordination and oversight and establishing start- up procedures, study implementation guidance, recruitment regulatory oversight, subject screening procedures oversight, and maintenance of subjects throughout multiple studies. This includes coordinating with possible various organizations including the FDA, CRO's, VMRF, SDVA IRB, SDVA Research program, as well as assisting multiple Principal Investigators with the day-to-day aspects of research studies. Incumbents will be responsible for protocol development, assistance with writing proposals, progress reports and manuscripts, creating informational and recruitment materials, maintaining and overseeing all regulatory activities, as well as acting as a liaison with other VA regulatory departments for the purpose of implementation and management of studies. Assure compliance with state and federal regulatory guidelines. This position will require developing, updating and refining Standard Operating Procedures that serve as the basis for the Program at the site; developing and maintaining a study data bases, including quality control of data. The incumbent will also assist in screening procedures including symptoms and diagnostic assessments for neuropsychiatric disorders.

Uses skills as a seasoned, experienced research compliance professional with a full understanding of industry practices and organization policies / procedures to apply federal, state, and university regulations, policies, and guidelines, and promote best practices. Interact frequently with investigators, people in other organizational departments, and occasionally people outside the University. Interactions require the use of tact and independent judgment, knowledge of standards and best practices, and counseling to resolve a wide range of research compliance issues. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Errors or omissions may ultimately place research participants at undo risk and / or compromise the institution's assurance of regulatory compliance with the federal government.

Requirements:
Masters’s degree (MA/MS) in a related field from an accredited college or university AND at least 4 years of related experience; or an equivalent combination of education and experience.