Regulatory Affairs Specialist II

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. Implements 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. Required Education and Experience 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. Required Credentials N/A. Preferred 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. Compensation Range $80,715.00 - $121,073.00 per year Salary Information This compensation range was calculated based on full-time employment (2080 hours worked per calendar year). Offers are determined by multiple factors including equity, skills, experience, and expertise, and may vary within the range provided. Disclaimer for Out of State Applicants This compensation range is specific to Seattle; positions located outside of Seattle may be compensated differently depending on various factors. Benefits Information Seattle Children’s offers a generous benefit package, including medical, dental, and vision plans, 403(b), life insurance, paid time off, tuition reimbursement, and more. Additional details on our benefits can be found on our website Equal Opportunity / EEO Statement Seattle Children’s welcomes people of all experiences, backgrounds, and thoughts as this is what drives our spirit of inquiry and allows us to better connect with our patients and families. Our organization recruits, employs, trains, compensates, and promotes based on merit without regard to race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. The people who work at Seattle Children’s are members of a community that seeks to respect and celebrate all the qualities that make each of us unique. Each of us is empowered to be ourselves. Seattle Children’s is proud to be an Equal Opportunity Workplace and an affirmative action employer. #J-18808-Ljbffr