IRB Regulatory Coordinator II - Infectious Disease Sciences

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

 

The Regulatory Coordinator works with faculty and staff in the Infectious Disease Sciences Program in the Vaccine and Infectious Disease Division to ensure all regulatory compliance measures are followed for clinical trials by coordinating regulatory submissions and monitoring as well as assisting with the resolution of compliance issues. 

 

The Regulatory Coordinator works on the Infectious Disease Sciences Program’s IRB and Regulatory team reporting to the team manager/supervisor. The position is expected to work independently within a framework of established regulations and guidelines, and demonstrate initiative and sound judgment in problem solving, providing regulatory guidance and developing policies and procedures. This position has significant interactions with the PI(s), other team members, internal departments and external organizations and agencies. 

• Prepare, track and maintain all correspondence and regulatory documentation required by the IRB, FDA, sponsors, and other institutional and federal oversight committees, including drafting and reviewing content as appropriate.
• Submit all regulatory documents to the IRB and other governing bodies to maintain study compliance with GCP, institutional and federal regulations.
• Maintain study regulatory binders and electronic files g. SharePoint, OneDrive, OnCore.
• Perform internal audit and quality assurance checks on regulatory documents.
• With input from PIs, study team, draft initial clinical research informed consent forms and study documents.
• Lead study start-up; prepare and submit all required regulatory documents for new study applications; successfully open new studies from inception to accrual.
• Prepare and present materials for monitoring visits; may serve as primary point of contact during visits.
• Independently follow-up and resolve all issues related to regulatory concerns identified during monitoring visits.
• Prepare and submit modifications/amendments, and continuing renewals for ongoing study maintenance in a timely manner.
• Conduct study close-out. Be responsible for archiving regulatory documents/records, ensuring that all files are prepared for off-site storage in accordance with FDA, other applicable regulatory guidelines and program SOP.
• Process IND external safety reports, maintain documentation of PI review and submit safety reports to the IRB as appropriate.
• Report non-compliance and unanticipated problems to the IRB as applicable.
• Serve as primary regulatory resource for PIs, sponsors, a study team, providing guidance on regulatory statuses, approvals and instructions regarding patient consent.
• Serve as liaison for internal regulatory bodies (IRB, Clinical Research Support, Regulatory Affairs, etc.)
• Stay abreast of new impacts/areas of knowledge and regulatory changes and disseminate this knowledge to the study/operations team. Work with IRB team and IDS leadership to develop standard operating procedures (SOPs).
• Identify, develop and implement any necessary revisions to related policies and procedures.
• Work with fiscal team/PI/study team regarding funding proposals, annual progress reports.
• Coordinate and manage the regulatory documents from each participating sites for studies where IDS serves as the IRB of record (coordinating center). Also track sites’ annual continuing reviews and alert sites to upcoming expirations to prevent lapses from occurring.

Minimum qualifications:

• Associates or Bachelor’s degree and a minimum two years of regulatory, human research protection or related experience in a research environment. 
• Demonstrated knowledge of regulatory guidelines (IB, IACUC, MUA, etc.), knowledge of FDA, GCP and NIH requirements, ability to interpret and synthesize regulations and guidelines.
• Ability to adapt and adjust priorities based on changing needs, strong written and verbal communication skills, problem solving skills, and the ability to reach and reconcile data in reports. 
• Ability to use discretion and maintain confidentiality. 
• Proficiency with MS Office suite.

Preferred qualifications:

• Certified IRB Professional (CIP) certification

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 escmail@fredhutch.org or by calling 206-667-4700.