Regulatory Affairs Associate Jobs

Overview: Responsibilities:

• Provide clear and concise professional communication in response to reviewing bodies and regulatory agencies.
• Perform other responsibilities as assigned.
• Use judgment to interpret and apply federal and local regulations regarding research.
• Prepare and coordinate study registration materials/submissions and assist with communications with sponsors and other stakeholders.
• Assist with sponsor monitoring visits remotely and onsite as needed.
• Assure the proper management, retention, and version control of all applicable regulatory documentation including master files and amendments.
• Serve as the subject matter expert for human subjects determinations for laboratory-based research proposals.
• Along with the PI and Regulatory Manager, prepare and track all clinical activity documents including IRB/IBC/site registration approvals, safety reports, deviations, laboratory certifications, staff training & licenses, monitoring notices and reports, inspections & compliance, etc.
• Assist in the coordination of project activities to ensure they follow timelines and meet deadlines.
• Assist in the development of project/study policies and procedures. Administer policies and procedures according to protocol, regulatory, and lab safety policies.
• Perform information searches related to studies and projects.
• Create, maintain, and audit systems for tracking and implementing regulated activities.
• Write and prepare regulatory submissions including applications, renewals, amendments, consent forms, safety reports, study updates, etc. in accordance with required timelines.
• Assist in the development of research materials.
• Provide regulatory support to IVD PIs working in multiple locations including the laboratories, the clinics and other external institutions.

Qualifications:

• Advanced knowledge of MS Word and Acrobat
• Excellent time management skills
• Ability to work collaboratively and build relationships across a large organization
• Excellent written and verbal communication skills including the ability to communicate clearly, succinctly and effectively over the phone and in writing
• Bachelor’s Degree in a related field or equivalent experience
• Skilled in the use of clinical trials and electronic document management systems
• Minimum of three years experience in clinical research with emphasis on IRBs, Ethics Committee and Human Subjects review for a pharmaceutical, biotechnology, or academic clinical research setting
• Skilled in technical writing and review of scientific documents
• Knowledge of US FDA regulations and guidelines that govern clinical research (GCP/ICH and IRB)

• IRB, Regulatory and/or Clinical research-related certification preferred (CIP, RAPS, ACRP, SOCRA)
• Previous experience with non-human subjects, exempt and minimal risk determinations
• Five or more years of experience in in clinical research with emphasis on IRBs, Ethics Committee and Human Subjects review for a pharmaceutical, biotechnology, or academic clinical research setting

The annual base salary range for this position is from $70,817 to $106,225 and pay offered will be based on experience and qualifications.

Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well-being, and financial security. Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, employee assistance program, onsite health clinic, tuition reimbursement, paid vacation (12-22 days per year), paid sick leave (12-25 days per year), paid holidays (13 days per year), paid parental leave (up to 4 weeks), and partially paid sabbatical leave (up to 6 months).

Our Commitment to Diversity: We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at [email protected] or by calling 206-667-4700.