Regulatory Affairs Specialist II

Seattle Children's•Seattle, WA

1d•$80,715 - $121,073•Onsite

About The Position

Serves as a subject-matter expert in quality assurance and regulatory support for clinical research at Seattle Children’s Research Institute. Guides and supports all clinical research team members in adhering to applicable federal regulations, state codes, institutional policies, and Institutional Review Board (IRB) oversight and review requirements when conducting research with human participants. Reviews, analyzes, and processes clinical research protocols, including associated documents, for submission to local and commercial IRBs. Assesses, analyzes, and implements regulatory requirements, policies, and guidance documents; creates and follows standard operating procedures (SOPs). Develops and delivers training and education to build and reinforce a culture of regulatory preparedness and quality assurance in clinical research practices, structures, and systems. Implement proven practices to ensure the quality of data collection and integrity, and documentation. Performs quality management activities in clinical research, ensuring research participants’ safety, quality of study operations, and compliance with applicable research regulations and ICH/GCP guidelines.

Requirements

Bachelor’s Degree in biological sciences or health related field.
Minimum of two (2) years experience in the pharmaceutical industry or clinical research organization in for-profit or academic setting.

Nice To Haves

Master’s Degree in biological sciences or health-related field.
At least five (5) years experience in a regulatory role.
Experience in drug and device approval process.
RAPS certification or equivalent.

Responsibilities

Guides and supports all clinical research team members in adhering to applicable federal regulations, state codes, institutional policies, and Institutional Review Board (IRB) oversight and review requirements when conducting research with human participants.
Reviews, analyzes, and processes clinical research protocols, including associated documents, for submission to local and commercial IRBs.
Assesses, analyzes, and implements regulatory requirements, policies, and guidance documents; creates and follows standard operating procedures (SOPs).
Develops and delivers training and education to build and reinforce a culture of regulatory preparedness and quality assurance in clinical research practices, structures, and systems.
Implement proven practices to ensure the quality of data collection and integrity, and documentation.
Performs quality management activities in clinical research, ensuring research participants’ safety, quality of study operations, and compliance with applicable research regulations and ICH/GCP guidelines.