Careers in Quality

The Regulatory Affairs Associate / Sr. Associate works with faculty and staff in the Infectious Disease Sciences (IDS) 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 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. Responsible for preparing IRB documents and FDA correspondence, maintaining regulatory files, and facilitates regulatory oversight for all related studies. This position has significant interactions with the PI(s), other team members, internal departments and external organizations and agencies.  The position reports to the Program Operations Director in the IDS Program.

Regulatory Affairs Associate

• 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 site 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
• Assist with the maintenance and management of  the regulatory tracking and archive systems (e.g. SharePoint, Clinical Trials Management System, shared network drive, etc.)
• Write and prepare regulatory submissions including applications, renewals, amendments, consent forms, safety reports, study updates, etc. in accordance with required timelines
• Prepare and coordinate site registration materials/submissions and assist with communications with sponsors and contract research organizations (CROs)
• Assist in the development of project/study policies and procedures. Administer policies and procedures according to protocol, regulatory, and lab safety policies
• In partnership with the PI, 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.
• Assure the proper management, retention, and version control of all applicable regulatory documentation including master files and amendments
• Assist in the coordination of project activities to ensure they follow timelines and meet deadlines
• Assist in the development of research materials
• Perform information searches related to studies and projects
• Use judgment to interpret and apply federal and local regulations regarding clinical research
• Perform other tasks as assigned

Regulatory Affairs Associate, Sr.—in addition to above responsibilities

• Serve as regulatory liaison for interdepartmental and external agencies including, but not limited to Office for Human Research Protections (OHRP), Regulatory Affairs Branch (RAB), the Fred Hutchinson Cancer Research Center’s Institutional Review Office and other research institutions site IRBs
• In conjunction with IDS Regulatory Coordinator, facilitate and track trial protocols through all applicable review and approval processes including, but not limited to FDA, IRBs, RAB, and in-country agencies
• Ensure that participating research sites have complied with all applicable regulatory requirements of the site registration process
• Provide regulatory oversight on safety reporting for the IDS Program and related studies
• Assist in compiling materials needed for investigational new drug (IND), submissions, IND safety reports, and annual reports as required
• Design, develop and implement SOPs that ensures the IDS Program conducts its regulatory activities in accordance with FDA/ICH regulations and guidance documents.
• Serve as an internal resource to address and resolve any questions or issues of a regulatory nature
• Prepare and submit regulatory documents, as well as manage the regulatory archive.
• Monitor, interpret and validate current and changing regulatory legislation and instructional polices, and ensure new regulations or changes to existing regulations are communicated throughout IDS to faculty and staff, and share potential impact these changes may have on ongoing protocols
• Manage sites who utilize the FHCRC IRB as the IRB of Record
• Provide expert review of non-lead IRB sites consent forms and other applicable regulatory documents
• Coordinate with others, as appropriate, to resolve highly complex or extraordinary regulatory problems that may arise
• Provide advice and counsel to the IDS faculty and staff and participating research institutions regarding regulatory requirements
• Identify potential regulatory risks to the operational plans of the IDS Program and propose options to mitigate risks

REGULATORY AFFAIRS ASSOCIATE

Minimum Education/Work Experience:

• Bachelor’s degree
• 3-5 years of experience working in regulatory affairs or related field with emphasis on INDs and IDEs in a pharmaceutical, biotechnology, or academic clinical research setting
• Preparing and reviewing IND applications
• Communicating with FDA and preparing for FDA inspections
• Assessing risk in the conduct of clinical research
• Designing tools for the regulatory management of clinical trials
• Interpreting federal regulations and guidelines

Qualifications:

• Previous work experience preparing and/or reviewing study start-up documents, including IRB documentation and research protocols
• Knowledge of FDA, ICH/GCP guidelines
• Strong verbal and written communication skills working across multiple disciplinary teams
• Ability to adapt and adjust priorities based on changing needs, and the ability to troubleshoot and problem-solving skill
• Excellent time management skills and meet deadlines
• Working knowledge of Microsoft Suite, SharePoint, Adobe Suite, Clinical Trials Management System

• Ability to use discretion and maintain confidentiality

SR. REGULATORY AFFAIRS ASSOCIATE

Minimum Education/Work Experience

• Minimum BS in Life Sciences, advanced degree preferred
• At least 5-7 years of experience working within the regulatory environment or related field with emphasis on INDs and IDEs in a pharmaceutical, biotechnology, or academic clinical research setting

Qualifications:

• Extensive and current working knowledge of FDA regulations, GCP, and International Conference on Harmonization guidelines
• Honed knowledge of clinical trial safety issues
• Excellent interpersonal skills and attention to detail
• Professional Society Certification (RAC) and background in pharmaceutical regulatory affairs or law strongly desired

Preferred Qualifications:

• Previous clinical research regulatory coordinator experience working within Fred Hutchinson Cancer Research Center or University of Washington’s institutional regulatory system
• Previous experience working with on-line/web-based platforms for clinical trial management systems
• Certified IRB Professional (CIP) certification preferred
• Knowledge of regulations and guidelines that govern clinical research, including but not limited to FDA regulations and Good Clinical Practice
• Master’s degree in regulatory affairs preferred—for Regulatory Affairs Associate Sr. level

Fred Hutch has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations.
As a condition of employment, newly hired employees must provide proof of vaccination or initiate the accommodations process before their first day of employment. 

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.